2016 Ss 0390

Supporting Statement

Importation of Chinese Sand Pears from China

OMB No. 0579-0390

March 2016

NOTE: This is a reinstatement of a previously approved information collection with changes.

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, Animal and Plant Health Inspection Service (APHIS), is responsible for preventing plant pests and noxious weeds from entering the

United States, preventing the spread of plant diseases not widely distributed in the United States, and eradicating those imported pests and noxious weeds when eradication is feasible.

Under the Plant Protection Act (7 U.S.C. 7701 – et seq), the Secretary of Agriculture is authorized to carry out operations or measures to detect, eradicate, suppress, control, prevent, or retard the spread of plant pests new to the United States or not known to be widely distributed throughout the United States.

The regulations in “Subpart – Fruits and Vegetables” Title 7, Code of Federal Regulations (CFR) 319.56 through 319.56-74, referred to below as the regulations), prohibit or restrict the importation of fruits and vegetables into the United States from certain parts of the world to prevent the introduction and dissemination of plant pests that are new to or not widely distributed within the United States.

APHIS amended the fruits and vegetables regulations to allow the importation of Chinese sand pears (Pyrus pyrifolia) from China into the United States. As a condition of entry, sand pears from areas of China in which the Oriental fruit fly (Bactrocera dorsalis) is not known to exist will have to be produced in accordance with a systems approach that will include requirements for registration of places of production and packinghouses; sourcing of a pest-free propagative organization of China; bagging of fruit; safeguarding; labeling; and importation in commercial consignments. Sand pears from areas in China in which Oriental fruit fly is known to exist can be imported into the United States if, in addition to these requirements, the places of production and packinghouses have a monitoring system in place for Oriental fruit fly and the pears are treated with cold treatment. All sand pears from China will also be required to be accompanied by a phytosanitary certificate with an additional declaration stating that all conditions for the importation of the pears have been met and that the consignment of pears has been inspected and found free of quarantine pests. This action will allow for the importation of sand pears from China into the United States while continuing to provide protection against the introduction of quarantine pests.

The regulations currently allow for the importation of both Ya pears (Pyrus bretschneideri) and fragrant pears (Pyrus sp. Nr. Communis) from China. The conditions for the importation of Ya pears are found in § 319.56.29 of the regulations, and those for fragrant pears are found in

§ 319.56-39 of the regulations.

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 its efforts to prevent the spread of plant pests and plant diseases from entering into the United States.

2. Indicate how, by whom, and for what purpose the information is 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 allow for the importation of sand pears from China into the United States while continuing to provide protection against the introduction of quarantine pests.

Operational Workplan (Foreign Government) 7 CFR 319.56-57 (a)(1)

An operational workplan will be required by the National Plant Protection Organization (NPPO) of China that details the activities for phytosanitary measures governing the import or export of a specific commodity and guidance procedures for the day-to-day operations.

Registration of Production Site (Business) and (Foreign Government) 7 CFR 319.56-57 (a)(2)

The pears must be grown at places of production that are registered with the NPPO of China.

Packinghouse Registration (Business) and (Foreign Government) 7 CFR 319.56-57 (a)(3)

The pears must be packed for export to the United States in pest-exclusionary packinghouses that are registered with the NPPO of China.

Test and Certification of Propagative Material (Foreign Government) 7 CFR 319.56-57 (b)(1)

All propagative material entering a registered place of production must be tested and certified by the NPPO of China as being free of quarantine pests.

Inspection of Registered Production Sites (Foreign Government) 7 CFR 319.56-57 (b)(4)

The NPPO of China must visit and inspect registered places of production prior to harvest for signs of infestations and allow APHIS to monitor the inspections.

Investigation for Recertification of Production Site (Business) and (Foreign Government)

7 CFR 319.56-57 (b)(5)

If any of the quarantine pests listed in the introductory text of this section are detected at a registered place of production, APHIS may reject the consignment or prohibit the importation into the United States of sand pears from the place of production for the remainder of the season. The exportation to the United States of sand pears from the place of production may resume in the next growing season if an investigation is conducted and APHIS and the NPPO conclude that appropriate remedial action has been taken.

Tracking System for Packinghouses (Business) 7 CFR 319.56-57 (c)(2)

Packinghouses must have a tracking system in place to readily identify all sand pears that enter the packinghouse destined for export to the United States back to their place of production.

Inspection of Packinghouse (Business) and (Foreign Government) 7 CFR 319.56-57 (c)(3)

The NPPO of China or officials authorized by the NPPO, must inspect the pears for signs of pest infestation and allow APHIS to monitor the inspections. If any of the quarantine pests listed in the introductory text of this section are detected in a consignment at the packinghouse, APHIS may reject the consignment.

Handling Procedure (Business) and (Foreign Government) 7 CFR 319.56-57 (c)(4)

Following the inspection, the packinghouse must follow a handling procedure for the pears that is mutually agreed upon by APHIS and the NPPO of China.

Labeling (Business) 7 CFR 319.56-57 (c)(5)

The pears must be packed in cartons that are labeled with the identity of the place of production and the packinghouse.

Phytosanitary Certificate with Declaration (Foreign Government) 7 CFR 319.56-57 (e)

Each consignment of sand pears imported from China into the United States must be accompanied by a phytosanitary certificate issued by the NPPO of China with an additional declaration stating that the requirements of this section have been met and the consignment has been inspected and found free of quarantine pests.

Trapping System (Business) 7 CFR 319.56-57 (f)(1)

The place of production of the pears and the packinghouse in which they are packed must have a trapping system in place for B. dorsalis. At a minimum, the trapping system must meet the requirements of the operational work plan.

Recordkeeping for Trap Location (Business) 7 CFR 319.56-57 (f)(2)

The place of production or the packinghouse must retain data regarding the number and location of the traps, as well as any pests other than B. dorsalis that have been caught, and make this information available to APHIS upon request.

Packinghouses Will Notify NPPO Regarding Detection (Business) and (Foreign Government) 7 CFR 319.56-57 (f)(3)(i) - The place of production or packinghouse must notify the NPPO of China, and the NPPO of China must notify APHIS, regarding the detection of a single B. dorsalis in a place of production, packinghouse, or surrounding area within 48 hours of the detection. The NPPO of China must provide records of pest detections and pest detection practices to APHIS, and APHIS must approve these practices. Records must be maintained for a minimum of 1 year.

Mitigation Measures for Detection at Production Sites (Business) and (Foreign Government) 7 CFR 319.56-57 (f)(3)(ii)

If a single B. dorsalis is detected in a registered place of production, APHIS will prohibit the importation into the United States of sand pears from the place of production until any mitigation measures determined by APHIS to be necessary to prevent future infestations are taken.

Mitigation Measures for Detection at Packinghouse (Business) and (Foreign Government) 7 CFR 319.56-57 (f)(3)(iii)

If a single B. dorsalis is detected in a registered packinghouse, the packinghouse may not be used to pack sand pears for export to the United States until any mitigation measures determined by APHIS to be necessary to prevent future infestations are taken.

(319.56.57(f)(4) Cold Treatment - The pears must be treated in accordance with 7 CFR part 305 and the operational workplan.

Certification of treatment facilities (Business) 7 CFR 305.6 (a)

- All facilities or locations used for refrigerating fruits or vegetables in accordance with the cold treatment schedules in the PPQ Treatment Manual or in another treatment schedule approved in accordance with §305.2 must be certified by APHIS. Recertification of the facility or carrier is required every 3 years, or as often as APHIS directs, depending on treatments performed, commodities handled, and operations conducted at the facility. 

Numbered Seal (Business) 7 CFR 305.6 (d)(6)

Only the same type of fruit in the same type of package may be treated together in a container; no mixture of fruits in containers may be treated. A numbered seal must be placed on the doors of the loaded container and may be removed only at the port of destination by an official authorized by APHIS.

Review of treatment records (Business) 7 CFR 305.6 (d)(12)

Cold treatment is not completed until so declared by an official authorized by APHIS or the certifying official of the foreign country; consignments of treated commodities may not be discharged until APHIS clearance has been fully completed, including review and approval of treatment record charts.

Audits (Business) 7 CFR 305.6 (d)(12)

An official authorized by APHIS may perform audits to ensure that the treatment procedures comply with the regulations in this section and that the treatment is administered in accordance with the treatment schedules in the PPQ Treatment Manual or in accordance with another approved treatment schedule. The official authorized by APHIS must be given the appropriate materials and access to the facility, container, or vessel necessary to perform the audits.

Monitoring (Business) 7 CFR 305.6 (e)

Treatment must be monitored by an inspector to ensure proper administration of the treatment. An inspector must also approve the recording devices and sensors used to monitor temperatures and conduct an operational check of the equipment before each use and ensure sensors are calibrated. An inspector may approve, adjust, or reject the treatment.

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.

CARPOL - As part of the overall e-Government directive to improve IT investments, APHIS began an Agencywide effort to consolidate and modernize its IT systems under an initiative termed e-File. The CARPOL project is a part of eFile that will combine more than eight separate APHIS IT systems used to generate and issue certificates, accreditations, registrations, permits, and other licenses CARPOL will also maintain information that is currently not part of any other system.

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.

The information APHIS collects is exclusive to its mission of preventing the entry of injurious plant pests, diseases, and noxious weeds and 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 APHIS collects in connection with this program is the minimum needed to

protect the United States from plant pests and diseases. APHIS has determined that 20 percent of the 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.

Failing to collect this information would cripple APHIS’ ability to ensure that sand pears from China are not carrying plant pests and would cause millions of dollars in damage to U.S. agriculture.

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;

The NPPO of China must notify APHIS regarding the detection of a single B. dorsalis in a place of production, packinghouse, or surrounding area within 48 hours of the detection.

• 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.

In 2015, APHIS held productive consultations with the following individuals concerning the information collection activities associated with the import of Chinese sand pears from China:

Bryant Christi, Inc.

Alise McConnell

International Regulatory Affairs

2005 "I" Street, Suite 200
Sacramento, CA 95811-3113
[email protected]

T 916-492-7062  /  F 916-492-7061

USA Pears

Pear Bureau Northwest

Kathy Stephenson
4382 SE International Way, Ste A
Milwaukie, OR 97222-4635
503-652-9720
503-652-9721 Fax

Washington Tree Fruit/Tree Fruit Technical Advisory Council

Jim Doornink

1719 Springwater Avenue

Wenatchee, WA 98801

509-665-8271

On Thursday, March 10, 2016, pages 12681-12682, 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 decisions to provide any payment or gift to respondents, other than remuneration of contractors or grantees.

This information collection activity involves no payments (other than appropriate, program-related 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 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 annualized cost to respondents for the hour burdens for collections of information, identifying and using appropriate wage rate categories.

The annualized cost to respondents is $9,862.50. APHIS arrived at this figure by multiplying the total burden hours (375) by the estimated average hourly wage of the respondents ($26.30).

$26.30 X 375 hours = $9,862.50.

$26.30 is the hourly rate derived from APHIS International Services’ discussions with officials from China.

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 costs, maintenance costs, and purchase of services in connection with this program.

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 $7,794.00. (See APHIS Form 79.)

15. Explain the reasons for any program changes or adjustments reported in Items 13 or 14 of the OMB Form 83-1.

ICR Summary of Burden:

	Requested	Program Change Due to New Statute	Program Change Due to Agency Discretion	Change Due to Adjustment in Agency Estimate	Change Due to Potential Violation of the PRA	Previously Approved
Annual Number of Responses	60,411	0	60,411	0	0	0
Annual Time Burden (Hr)	384	0	384	0	0	0
Annual Cost Burden ($)	0	0	0	0	0	0

This reinstatement is a program change resulting in increase of +29 respondent and +60,411 responses resulting in an increase of +384 burden hours.

The increase is due to additional burden items that were erroneously omitted from the previous collection. The additional items include: production site and packing house registrations, Certification of Propagative Material, investigations for re-certifications of production sites and packinghouses, tracking systems, NPPO inspections of pears, handling procedures, additional requirements for pears harvested below the 33^rd Parallel (trapping systems, recordkeeping, notifications of detections, and cold treatment requirements).

16. For collections of information whose results are planned to be published, outline plans for tabulation and publication.

APHIS has no plans to publish this data.

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.

There are no USDA forms involved in this information collection.

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 in the Act.

B. Collections of Information Employing Statistical Methods

Statistical methods are not used in this information collection.