Reference Manual A 

(RM-A) 

NATIONAL SEED HEALTH 

SYSTEM (NSHS)

REFERENCE MANUAL FOR 

ADMINISTRATION, PROCEDURES, 

AND POLICIES OF THE NSHS 

 

 

 

 

Version dated

 10/20/09 

 
Contents 

TABLE OF CONTENTS.. ................................................................................................2 

 

INTRODUCTION..............................................................................................................3 

SECTION ONE .................................................................................................................4 

Administration, Organization, and Structure of the NSHS 

 

1.1 Overview ...........................................................................................................4 

 

1.2 Administration of the NSHS..............................................................................8 

 

1.3 Auditors ...........................................................................................................19 

 

1.4 Accreditation Process.......................................................................................20 

 

SECTION TWO: .............................................................................................................26 

Process of Accreditation 

 

2.1 Purpose of Accreditation .................................................................................26 

 

2.2 Accreditation Procedures ................................................................................26 

 

2.3 Relationship between the NSHS and the Applicant or Accredited Entity.......30 

 

SECTION THREE: .........................................................................................................32 

Evaluation and screening of laboratory seed heath testing, seed sampling, visual 

inspections, and phytosanitary field inspections methodologies 

3.1 Criteria for the Evaluation and Screening of Seed Health Testing 

 Methodologies............... 32 

3.2 Criteria for the Evaluation of Phytosanitary Field Inspection Methodologies 34 

3.3 Criteria for the Evaluation of Sampling Procedures........................................34 

3.4 Criteria for the Evaluation of Visual Inspection Methodologies.....................34 

GLOSSARY OF TERMS ...............................................................................................35 

 

REFERENCES.................................................................................................................38 

APPENDIX A: .................................................................................................................39 

Quality System and the Quality Manual 
3

INTRODUCTION 

Seed Health Accreditation Program 

The U.S. Seed Health Accreditation Program, in the form of the NSHS has been 

established by the U. S. Department of Agriculture-Animal and Plant Health Inspection 

Service (USDA-APHIS) to accredit entities to perform laboratory seed heath testing, seed 

sampling, visual inspections, and phytosanitary field inspections. Authority for the 

establishment and operation of the seed health accreditation program are described in 

Title 7 Code of Federal Regulations (7 CFR) Parts 300 and 353. 

NSHS 

The NSHS has been established in cooperation with the USDA-APHIS, the National 

Plant Board (NPB), the Association of American Seed Control Officials (AASCO), the 

Association of Official Seed Certifying Agencies (AOSCA), and the American Seed 

Trade Association (ASTA). 

 

The three main objectives of the NSHS are as follows: 

 

1. To develop standardized seed health laboratory test procedures, seed sampling 

procedures for laboratory seed health testing, visual inspections procedures, 

and phytosanitary field inspection procedures; 

2. To develop a process to accredit private and public entities to carry out the 

above mentioned activities (see seed health accreditation program); and 

 

3. To leverage this initiative as well as other international initiatives to promote 

international phytosanitary reform and foster fair equitable trade. 
4

SECTION ONE: Administration, Organization, and Structure of the 

NSHS

1.1 OVERVIEW

1.1.1 NSHS

The NSHS is a cooperative government and industry consortium formed to address seed 

health and trade problems in an orderly, scientific, and systematic manner. The goals are 

promoting trade while protecting agriculture, the environment, and the economic well 

being of the interested and affected parties.

1.1.2 USDA-APHIS 

The USDA-APHIS has responsibility for the Seed Health Accreditation Program in the 

form of the NSHS. (See Section 2; Administration of the NSHS) 

 

The Administrator1 of APHIS, or his designee (the USDA-APHIS Accreditation Manager 

(AM)), acts as an ex-officio member of the Policy and Procedures Advisory Board 

(PPAB) of the NSHS. The AM responsibilities are outlined in Section 2.3.1. This person 

is responsible for maintaining oversight functions of the NSHS. 

 

1.1.3 NPB Council/ Plant Protection and Quarantine (PPQ) Strategy Team 

The Strategy Team is a group of state and USDA plant health officials that provides 

program review of pest management programs within the U.S. Their function is to 

provide policy recommendations and identify issues important to the USDA and the 

states. The Strategy Teams’ involvement in the Seed Health Accreditation Program is to 

review the program and provide input to the Administrator.

1.1.4 PPAB

The PPAB acts as the primary body giving direction to the NSHS. The PPAB contains 

one member each from the National Plant Board (NPB), the American Association of 

Seed Control Officials (AASCO), the Association of Official Seed Certifying Agencies 

(AOSCA), and three members from the American Seed Trade Association (ASTA). The 

director(s) of the Administration Units (AU) and the Administrator of APHIS (or his 

designee) participate as ex-officio members of the PPAB. 

The PPAB determines specific host/pathogen combinations for which test methods are 

developed, with recommendations from groups such as the ASTA Veg-Tech 

Subcommittee, etc. They assist in setting the agenda for the Administration Unit’s (AU) 

activities and priorities. The PPAB reviews the results and recommendations of the 

 

1

 The Administrator delegates this authority to the AM on his or her behalf as listed at 7 CFR 301.38-1. 
5

Technical Panels, makes any recommendations based on their review, and forwards them 

to the Administrator for approval. Following USDA-APHIS approval, these results are 

included in Reference Manual B for official use in phytosanitary certification. The PPAB 

also approves checklists of equipment and facilities that can be used to evaluate 

accreditation candidates. 

 

1.1.5 Technical Panels 

Technical Panels are chosen from a pool of ‘qualified experts’ based on their area of 

expertise to serve as volunteers to review existing and propose new: seed health 

laboratory test procedures, seed sampling procedures for laboratory seed health testing, 

visual inspections procedures, and phytosanitary field inspection methodologies. The 

panels may consist of experts from the private and public sectors and are open to experts 

from other countries as well. 

Methods that have not been reviewed by a Technical Panel for host/pathogen 

combinations and have already been reviewed by ISHI or ISTA may be published in 

Reference Manual B as “B” rated methods until passed by a Technical Panel. These 

laboratory testing ISHI/ISTA methods that are non-Technical Panel reviewed are 

approved for publication by the PPAB. 

The recommendations of the panels are reviewed by the PPAB. In certain cases, where 

additional research and development are required, financial support is provided to 

technical experts or the AU for specified uses as approved by the PPAB. 

1.1.6 AUs

The AU(s) manages the day-to-day activities of the NSHS on behalf of the USDAAPHIS as follows: 

 

1.1.6.1 The AU receives and processes applications from entities wishing to 

become accredited;

1.1.6.2 The AU schedules and coordinates the accreditation and recertification 

audits with the applicants and accredited entities; 

1.1.6.3 The AU coordinates and conducts appropriate training sessions and 

workshops in the appropriate areas of plant health for applicant entities, as 

needed; 

1.1.6.4 The AU assists in performing proficiency testing, if deemed necessary by 

USDA-APHIS, as part of resolving any phytosanitary issues; 

1.1.6.5 The AU is the official “record keeper’ of the system and maintains the 

controlled versions of all reference materials including the standardized test 

and inspection methodologies;
6

1.1.6.6 The AU engages in test/inspection standardization and development;

1.1.6.7 The AU makes provisions for the testing of “minor use crops;” 

 1.1.6.8 The AU develops lists of experts from which volunteers are selected to 

 serve on Technical Panels. The selection process is under the guidance of 

the PPAB and the AM; and

1.1.6.9 The AU collects and organizes the relevant body of scientific information 

for review and consideration by the Technical Panels. 

1.1.7 Accredited Entities (AE’s) 

AEs are any public or private organization (or individual) that meet the requirements for 

accreditation as outlined in this manual and the regulations at 7 CFR 353.9. Private AE’s 

are allowed to perform only those seed health laboratory test procedures, seed sampling 

procedures for laboratory seed health testing, visual inspections procedures, and 

phytosanitary field inspection procedures for which they have been accredited. AE’s will 

adhere to a regular program of surveillance audits and proficiency testing as required by 

the Administrator and/or as outlined in this manual and the regulations at 7 CFR 353.9.

 
7

 
8

1.2 ADMINISTRATION OF THE NATIONAL SEED HEALTH SYSTEM 

 

1.2.1 General Provisions 

 

 1.2.1.1 The procedures under which the NSHS operates are administered in a 

 nondiscriminatory manner. 

 

 Access to the NSHS is not conditional upon the size of the operation, laboratory 

 or membership of any association or group, nor are there any undue financial 

 conditions restricting participation. 

 

 1.2.1.2 The competence of an applicant entity to conduct seed health laboratory 

 test procedures, seed sampling procedures for laboratory seed health testing, 

 visual inspections procedures, and/or phytosanitary field inspection procedures is 

 assessed according to the accreditation standards established by the USDA-

 APHIS and the procedures contained within this document. 

 

 1.2.1.3 The NSHS is administered in a manner that requires AEs to maintain 

 impartiality and integrity. 

 

 1.2.1.4 The administration of the NSHS is organized as outlined in Figure 1. The 

 NSHS is organized in a manner that gives the USDA-APHIS oversight 

 responsibility for the accredited portion of the NSHS in order to maintain the 

 integrity of the international phytosanitary system. The USDA-APHIS 

 participates as an ex-officio member of the PPAB in the approval of 

 standardized seed health laboratory test procedures, seed sampling procedures for 

 laboratory seed health testing, visual inspections procedures, and phytosanitary 

 field inspection procedures. 

1.2.2 Organizational Requirements of the NSHS Administration 

 

1.2.2.1 The USDA-APHIS AM and the AU: 

 a. Are legally identifiable entities; 

 

 b. Have rights and responsibilities relevant to NSHS accreditation 

 activities; 

 

 c. Have adequate arrangements to cover liabilities arising from operations 

 and/or activities; 

 

 d. Have the financial stability and resources required for the operation of 

 an accreditation system; 

 

 e. Have and make available on request a description of the means by 
9

 which each receives financial support; 

 

 f. Employ a sufficient number of personnel having the necessary 

 education, training, technical knowledge, and experience for handling the 

 type, range, and volume of work performed, under a senior executive who 

 is responsible to the organization, body, or board to which it reports; 

 

 g. Have a quality system including an organizational structure, that 

 enables each to give confidence in their ability to operate an accreditation 

 system satisfactorily; 

 

 h. Have documented policies and procedures for the operation of the 

 quality system that include: 

 

 i. Policies and decision-making procedures that distinguish 

 between accreditation and any other activities in which the body 

 is engaged; and 

 

 ii. Policies and procedures for the resolution of complaints and 

 appeals received from AEs about the handling of accreditation 

 matters, or from users of services about AEs or any other matters; 

 

 i. Together with its senior executive, and staff, be reasonably free from 

 any commercial, financial, and other pressures which might influence the 

 results of the accreditation process; 

 

 j. Have formal rules and structures for the appointment and operation of 

 committees involved in the accreditation process; such committees are 

 reasonably free from any commercial, financial, and other pressures that 

 might influence decisions, or they have a structure where members are 

 chosen to provide impartiality through a balance of interests where no one 

 interest predominates; 

 

 k. Establish one or more technical committees or panels, each responsible 

 within their scope, for advising the AM and AU on the technical matters 

 relating to the operation of their accreditation system; 

 

 l. Will not offer consultant or other services potentially compromising the 

 objectivity of their accreditation process and decisions; and 

 m. Have arrangements that are consistent with applicable laws, to 

 safeguard, at all levels of their organization (including committees), 

 confidentiality of all information obtained relating to applications, 

 assessments, and accreditation of applicants. 

 

1.2.2.2 The AM and AU have written procedures for controlling the ownership, 
10

use, or display of accreditation documents. Both also have procedures the AE 

utilizes to refer to their accredited status. 

 

1.2.3 Administration Structure for the NSHS

1.2.3.1 The AM (USDA-APHIS): 

 

 a. Is an appointee of the USDA-APHIS and maintains oversight functions 

 of the accredited portion of the National Seed Health System; 

 b. Upholds the regulations and rules governing units of the Federal 

 government, and is subject to the organizational requirements of Section 

 1.1; 

 

 c. Is an integral part of the accreditation system and works closely with the 

 PPAB (Section 1.3.3) and the National Plant Board/PPQ Strategy Team 

 (Section 1.3.4) to set and maintain policy and priorities of the 

 accreditation system; 

 d. Grants official accreditation to applicant entities as a representative of 

 the USDA-APHIS according to the provisions of the standards for 

 accreditation; 

 e. Directs the AU(s) in the activities of accreditation. This includes 

 establishing the priorities, criteria, and regulations for accreditation of 

 non-government entities; and 

 f. May conduct independent audits of the AUs. 

1.2.3.2 The AUs: 

 a. Are designated by a Memorandum of Understanding (MOU) from 

 the USDA-APHIS; 

 b. Are a legally identifiable, public or private, entity; 

 c. Are an affirmative action, equal opportunity employer; 

 d. Confine their requirements, assessments, and decisions on accreditation 

 to those matters specifically related to the scope of the accreditation being 

 considered; 

 e. Are subject to the organizational requirements of Section 1.5; 

 f. Are responsible for the organization and implementation of the 

 accreditation processes outlined in the standards for accreditation; 
11

 g. Train and appoint auditors according to the provisions in Section 2 and 

 for final approval by the AM; 

 h. Maintain procedures and protocols for applicant entities in a manner 

 that assures impartiality and maintains the provisions of the quality system 

 (Section 2.4); and 

 i. Organize and/or hold training workshops, as needed, to assure that 

 applicant entities can meet the requirements of the Seed Health 

 Accreditation Program. 

1.2.3.3 The PPAB shall consist of six (6) members: 

a. One member of the NPB (National Plant Board); 

b. One member from AASCO (Association of American Seed Control 

Officials); 

c. One member of AOSCA (Association of Official Seed Certifying 

Agencies); and 

d. Three members from ASTA (American Seed Trade Association). 

1.2.3.4 Ex-officio members of the PPAB are the AM and the director(s) of the 

AU(s). 

 

1.2.3.5 The PPAB develops policies and procedures for the AM, provides 

 technical expertise and information deemed necessary for the AM to effectively 

 administer the system, and performs other duties as outlined in Section 1.1.4. 

1.2.3.6 The NPB/PPQ Strategy Team consists of members from the NPB and the 

USDA-APHIS. This team: 

 

 a. Provides the AM with policy coordination, reviews, and 

 recommendations; 

 b. Reviews the provisions of the accreditation system on behalf of the 

 AM; and 

 c. Resolves issues of regulatory procedures to assure accreditation system 

 integrity. 

1.2.4 AU Quality System 

 

1.2.4.1 The AU operates a quality system according to the type, range, and 
12

volume of the work performed. This system is documented and the documentation 

is available for use by the AU staffs. The AUs designate a specific person to 

communicate directly with the AM, to be responsible for the quality system, and 

to maintain the quality documentation. 

 

 1.2.4.2 The quality system is documented with a quality manual or equivalent 

 documentation and relevant quality procedures. The quality manual contains or 

 refers to, at a minimum: 

 

a. A quality policy statement; 

 b. The organizational structure of the accreditation body; 

 c. The operational and functional duties and services pertaining to quality; 

 each person involved is able to refer to this information to ascertain the 

 extent and the limits of their responsibility; 

 d. Administrative procedures including document control; 

 e. Policies and procedures to implement the accreditation process; 

 f. Procedures for feedback and corrective actions to address discrepancies 

 after detection; 

 g. The policies and procedures for responding to appeals, complaints, and 

 disputes; 

 h. The policies and procedures for conducting internal audits; 

 i. The policies and procedures for conducting quality system reviews; 

 j. The policies and procedures for the recruitment and training of auditors 

 and for monitoring their performance. 

1.2.4.3 The AUs audit their activities at a minimum of once a year to verify 

compliance with the requirements of the quality system. The quality system is 

also reviewed to ensure its effectiveness. Audits and reviews are performed 

systematically and periodically and also include details of any corrective actions 

performed. 

 

1.2.4.4 The AUs maintain records to document accreditation procedures have 

been effectively performed, including but not limited to, application forms, 

regular audit reports, and reports related to granting, maintaining, extending, 

suspending, or withdrawing accreditation. These documents form part of the 

official record. 

 
13

1.2.4.5 The AUs have policies and procedures for retaining records for a period 

consistent with their contractual and legal obligations. The AUs also have policies 

and procedures for accessing these records consistent with Section 2.2 of this 

document. 

 

1.2.5 Granting, Maintaining, Extending, Suspending, and Withdrawing 

Accreditation 

 

 1.2.5.1 The AM, through technical advice from its committees, specifies the 

 conditions for granting, maintaining, and extending accreditation and the 

 conditions under which accreditation will be suspended or withdrawn, partially or 

 in full for all or part of the AE’s scope of accreditation. 

 1.2.5.2 The AM has procedures to grant, maintain, suspend, or withdraw 

 accreditation, and also to increase or reduce the scope of accreditation or to 

 require reassessment, due to changes affecting the AE's activity and operation. 

 This includes changes, such as personnel or equipment, or if the investigation of a 

 complaint or any other information indicates that the AE no longer complies with 

 the requirements of their quality system. 

 1.2.5.3 The AM reviews the accreditation status relating to the transfer of 

 accreditation when the legal status (e.g., ownership) of the AE changes. 

 1.2.5.4 These responsibilities are detailed in: 7 CFR 353: Accreditation Standards 

 for Laboratory Seed Health Testing and Seed Crop Phytosanitary Inspection 

 

1.2.6 In Order to Maintain Accreditation, the AE Must: 

 

1.2.6.1 Perform all work for which it is accredited in conformance with their 

approved protocols, methods, or procedures; 

 1.2.6.2 Be re-assessed (via a re-certification audit) and evaluated on a three year 

schedule by providing a report of activities (positive and negative issues and 

suggestions), send an updated Quality Manual to the AU, which would include 

any new methods, and undergo an external audit. An option of referee 

(proficiency) testing may be required of the AE under circumstances as deemed 

necessary by the AM and/or another USDA-APHIS official. The AU is 

responsible for scheduling the audit and any necessary proficiency testing; 

1.2.6.3 Demonstrate on request that it is able to perform the procedures for which 

it is accredited; 

1.2.6.4 Be able to perform the laboratory seed health tests or inspection services 

for which it is accredited. If at any time, an AE is determined by the AM to be 

unable to perform accredited duties, they will immediately cease those activities 

until they can demonstrate to the AM’s satisfaction that corrective action has been 
14

identified and implemented;

1.2.6.5 Notify the AM immediately (within two business days) of any changes in 

key management personnel or staff responsible for the testing or phytosanitary 

inspection services for which the entity is accredited; 

1.2.6.6 Notify the AM within five business days, of any changes in the location, 

ownership, physical facilities, equipment, or other pertinent conditions that 

existed at the facility at the time of accreditation and are critical to the 

performance of the accreditation functions; and 

1.2.6.7 Pay all fees required to cover costs associated with audits, proficiency 

tests, or other work performed by the AU. 

1.2.7 Refusal, Suspension or Cancellation, and Notification 

 

 1.2.7.1 Applications that are incomplete, unsigned, or signed by an unauthorized 

 person or not on the USDA-APHIS approved forms will be refused. Notice of any 

 refusal shall be provided within 15 working days of receipt, not including the time 

 for mail or other delivery delay. Re-application may not be made for 90 days after 

 a notice of refusal. A new application fee is required with any reapplication. 

 1.2.7.2 Accreditation is refused if the AM determines that the applicant does not 

 met the requirements, has falsified any information provided on the application or 

 to the AU, or fails to pay any fees. The applicant shall be notified of refusal 

 within 15 days of a determination by the AM. 

 1.2.7.3 Accreditation is re-evaluated within 90 days of any change of ownership. 

 Based upon this evaluation, the AM may also require an audit. 

 1.2.7.4 Incidences of non-compliance are defined as either Critical, Major, or 

 Minor. This depends on the extent to which they effect the AE’s ability to 

 continue to provide confidence that the performance of the AE meets the 

 conditions established in this standard. 

 a. A Critical Non-Compliance is defined as: 

An audit finding that reveals that the integrity of the program is 

jeopardized. The result of this finding indicates the tests or inspection 

findings could not be utilized as supporting documentation for the 

issuance of the phytosanitary certificate. 

 Critical Non-Compliance incidences include, but are not limited to: 

 

 i. No inspection or test conducted; 
15

 ii. Failure to follow inspection/testing methods in accordance with 

 this standard; 

 iii. A deliberate attempt to provide incorrect results of an 

 inspection or testing; 

 iv. Three or more Major Non-Compliance items detected in any 

 one audit; and 

 v. Any reoccurrence of the same Major Non-Compliance detected 

 in the two previous consecutive audits. 

 Action taken for Critical Non-Compliance: The AE is notified of their 

 violation of the Standard. The AE is removed from the approved list until: 

 i. An agreed corrective strategy has been identified by the AU, the 

 AM, and the AE; and 

 ii. An audit is completed of all areas found not to be in compliance, 

 if designated as required by the corrective strategy. 

 b. A Major Non-Compliance is defined as: 

 An audit finding that reveals an isolated incident(s) that results in 

 decreased confidence of the AE’s inspection, sampling, or testing results; 

 however, it does not have a direct impact on the integrity of the program. 

 Corrective action is required immediately so that implementation is in 

 place to retain confidence that the conditions of the Standard are being 

 fulfilled. 

 

 Major Non-Compliance incidences include, but are not limited to: 

 i. A significant difference between the Auditor’s and AE’s 

 inspection and/ or test findings; 

 ii. The AE fails to identify, classify, or record problems correctly; 

 iii. Lack of inspection facilities and/or equipment; 

 iv. Internal audits are not conducted or properly documented; 

 v. Actions taken following audits are not recorded; 

 vi. Documentation is unavailable for auditors; 
16

 vii. Corrective action for a Minor Non-Compliance(s) is not 

 implemented within the agreed time-frame; and 

 viii. Three or more Minor Non-Compliance incidents result from 

 any one audit. 

Action taken for a Major Non-Compliance: 

 i. When one or more Major Non-Compliance incidents 

 are identified during the initial accreditation audit, the 

 entity will not be accredited. 

 ii. When one or two Major Non-Compliance incidents are 

 identified during a surveillance audit, corrective action is 

 required for implementation as soon as possible. An 

 additional audit may be conducted to confirm that the 

 corrective actions have been made. 

 

 iii. A Critical Non-Compliance will be recorded for every 

 three Major Non-Compliance incidents identified during a 

 single visit. 

 

 c. A Minor Non-Compliance is defined as: 

 An audit finding that reveals a non-conformance that does not 

 immediately and/ or significantly affect the integrity of the program. 

 Corrective actions must be undertaken no later than the next audit, or 

 within a time-frame agreed to by the Auditor and Entity. 

 

 Minor Non-Compliance incidents include, but are not limited to: 

 i. Any amendment to procedural details that is not documented; 

 ii. An incomplete inspection, testing, or audit record, such as: 

 (1) No recording of critical test steps; 

 (2) No signing of records and recording of dates; 

 (3) Improper grower identification; 

 (4) Improper sample identification; 

 (5) Incomplete inspection and testing facilities or 

 equipment; or 

 
17

 (6) Any other deviations from the Entity’s Quality Manual. 

 

 Action taken for Minor Non-Compliances: A Major Non Compliance 

 will be recorded for every three (3) Minor Non Compliance incidents 

 identified during an audit. 

 

 1.2.7.5 If a Non Compliance not covered by the above examples and definitions is 

 identified, it will be classified as a Major Non Compliance incident until clarified 

 by the AM. 

1.2.8 Corrective Action Implementation 

1.2.8.1 A corrective action and a time frame for implementation will be agreed 

between the Auditor and the Entity for each non-compliance. The auditor verifies 

that the corrective action has been implemented and is operating effectively 

within the agreed time frame. Any non-compliance incident will be accompanied 

by an action plan. Failure to follow the action plan may result in cancellation of 

accreditation. 

1.2.8.2 The Auditor provides the entity with a list of all corrective actions to be 

taken to identify and correct system non-compliances. Corrective actions will 

outline: 

 

a. What will be done; 

b. By whom it will be done; 

c. The time frame for implementation of the corrective action; and 

d. The verification activities to be undertaken to ensure that corrective actions 

have been successfully implemented. 

1.2.9 Corrective Action Non-Implementation

When agreed-upon corrective actions for Major or Critical Non Compliances are not 

implemented, the entity is subject to suspension of accreditation. 

 

1.2.10 Suspension or Cancellation

When accreditation is suspended or cancelled, the AE and all certifying officials will be 

notified within 48 hours by telephone, electronic mail, facsimile, overnight mail, or 

courier service. The AE will immediately cease activities for which a major or critical 

non-compliance has been recorded. 

1.2.11 AM Suspension or Cancellation Responsibilites 
18

The AM apprises the AE of the reason(s) for suspension or cancellation, the corrective 

action(s) required, and the process for re-accreditation. 

1.2.12 AE Corrective Measures Requirements and Re-accreditation 

The AE is responsible for notifying the AM of corrective measures taken and for 

requesting re-accreditation. Re-accreditation may be granted when the corrective 

measures have been verified to the satisfaction of the AM. 

1.2.13 Appeals

Appeal of any refusal, suspension, or cancellation of accreditation by the AM may be 

made within 5 working days of notification. The AM then makes a determination and 

notifies the appellant within 15 working days. The AM’s decision is final. 

1.2.14 Dispute Resolution 

Disputes relating to testing or inspections results will be resolved by a mediator or trained 

arbitrator, according to the AM’s discretion. The mediation or arbitration panel will 

consist of testing or inspection professionals with expertise in the disputed testing or 

inspection protocol(s) or procedure(s) 

1.2.15 Documentation 

1.2.15.1 The AU will provide updates at adequate intervals and make available 

upon request through publications, electronic media, or other means. These will 

include the following: 

a. Information on the authority under which accreditation systems operated by 

the AM are established. This will also specify whether they are mandatory or 

voluntary; 

 

 b. A document containing the requirements for accreditation in accordance 

with this document; 

 

 c. The Standards for Accreditation identifying the requirements for granting, 

maintaining, extending, suspending, and withdrawing accreditation; 

 

 d. Information about the assessment and accreditation processes; 

 

 e. General information on the fees charged to the applicant and the AE; and 

 

 f. A description of the rights and duties of the AE as specified in Clauses 4.1, 

4.2, and 4.3 of this document, including requirements, restrictions, or 

limitations on the use of the NSHS logo and on the ways of referring to the 

accreditation granted. 
19

1.3 AUDITORS 

 

1.3.1 Requirements for Auditors 

The auditor or auditor team appointed to assess an applicant: 

 

 1.3.1.1 Is familiar with the relevant legal regulations, accreditation procedures, 

 and accreditation requirements; 

 1.3.1.2 Has a thorough knowledge of the relevant audit method and documents; 

 1.3.1.3 Has appropriate technical knowledge of the identified seed health tests, 

 plant health inspection protocols, or the visual and sampling procedures relevant 

 to the accreditation; 

 1.3.1.4 Is able to communicate effectively, both orally and in writing; 

 

 1.3.1.5 Is reasonably free of any commercial, financial, or other pressures or 

 conflicts of interest leading the auditor(s) to act in an unfair or discriminatory 

 manner; and 

 1.3.1.6 Has not have offered consultant services to the applicant potentially 

 compromising their impartiality in the accreditation process and decisions. 

 

1.3.2 Qualification Procedures for Auditors

The AM has an adequate procedure for: 

 

 1.3.2.1 Qualifying auditors, through an assessment of their competence and 

 training, and by attending one or more actual training sessions with a qualified 

 auditing program; 

 1.3.2.2 Monitoring the performance of auditors. 

 

1.3.3 Contracting of Auditors

 The AU requires the auditors to sign a contract or other document by which they commit 

themselves to comply with the rules defined by the NSHS. These include rules pertaining 

to confidentiality as well as those relating to independence from commercial and other 

interests, and to any prior association with the applicant undergoing auditing. 

 

1.3.4 Auditor Records 

 The AU shall possess and maintain up-to-date records of all auditors consisting of their: 

 1.3.4.1 Name and address; 
20

 1.3.4.2 Organization affiliation and position held; 

 1.3.4.3 Educational qualification and professional status; 

 1.3.4.4 Work experience; 

 1.3.4.5 Training in procedures involving seed health laboratory testing, seed 

 sampling for laboratory seed health testing, visual inspections, and phytosanitary 

 field inspection; 

 1.3.4.6 Experience in procedures involving seed health laboratory testing, seed 

 sampling for laboratory seed health testing, visual inspections, and phytosanitary 

 field inspection; and 

 1.3.4.7 Date of most recent record revision. 

 

1.3.5 Procedures for Auditors

Auditors are provided with an up-to-date set of procedures outlining auditing instructions 

and all other relevant information required to perform an audit. 

 

1.4 ACCREDITATION PROCESS 

 

1.4.1 Application for Accreditation 

 

1.4.1.1 A detailed description of the audit and accreditation procedure, documents 

containing the requirements for accreditation, and documents describing the rights 

and duties of the applicant (including fees to be paid by the applicant) are current 

and are provided to the applicants by the AU. 

1.4.1.2 Additional relevant information is provided to applicants on request. 

1.4.1.3 The AU supplies an application form that provides for the collection of all, 

but not limited to, the applicant’s following information, authorization, and 

agreements: 

 

 a. Legal name and full address (mail and business); 

 b. Name, address, telephone and fax numbers, and e-mail address (if 

 available) of the responsible individual or his/her authorized 

 representative; 

 c. A description of the entity, including its physical facilities, primary 

 function, scope of operation, and relationship to its larger corporate entity; 
21

 d. A description of the laboratory testing or phytosanitary inspection 

 services for which the entity is seeking accreditation; 

 e. Authorization for auditors to access the applicant’s facilities and review 

 relevant records during normal business hours; 

 f. Agreement to provide all relevant information requested by the auditor; 

 and 

 g. Agreement to pay all accreditation fees as billed in order to cover costs 

 incurred while conducting accreditation audits. This includes travel costs 

 for the auditor. 

1.4.1.4 To apply for accreditation, the applicant obtains, completes, signs, and 

submits an application to the AM along with the required fees. Applications that 

are incomplete or unsigned, or not on the USDA-APHIS/NSHS approved forms 

will be rejected. A notice of rejection will be issued within 15 working days (not 

including the normal time for delivery by mail).

1.4.1.5 Confidential Business Information (CBI) will not be disclosed by the AM, 

the AU, or independent auditors, to any unauthorized persons according to the 

applicant or the AE.

1.4.1.6 A duly authorized representative of the applicant is required to sign an 

official application form, which includes (and/ or may be attached): 

 

 a. The clearly defined scope of the desired accreditation; 

 b. The applicant’s representative’s agreement to fulfill the accreditation 

 procedure which includes receiving the assessment team, paying the fees 

 charged to the applicant regardless of the result of the assessment, and 

 accepting the charges of subsequent maintenance of the accreditation; 

 and 

 c. The applicant’s agreement to comply with the requirements for 

 accreditation and to supply any information needed for the evaluation. 

1.4.1.7 The following minimum information is provided by the applicant prior to 

the on-site assessment (as listed in the application form): 

 

 a. The general features of the applicant (corporate entity: name, address, 

 legal status, and human and technical resources); 

 

 b. General information concerning the applicant covered by the 

 application (such as the primary function), relationship to/ in a larger 

 corporate entity, and, if applicable, physical location of all facilities 
22

 involved; 

 

 c. A descriptive list of the procedures for: seed health laboratory testing, 

 sampling, and visual inspections, and phytosanitary field inspections for 

 which accreditation is sought; and 

 

 d. A copy of the applicant’s quality manual and associated documentation. 

 

1.4.1.8 This information used for the preparation of the on-site assessment will be 

treated as confidential. 

 

 1.4.1.9 Fees for accreditation are described in the official NSHS application form. 

1.4.1.10 Upon receipt of an application, the AM will review the application for 

completeness and in order to determine the scope of the audit that will be required 

to adequately review the entity’s fitness to conduct accredited seed health 

laboratory test procedures, seed sampling procedures for laboratory seed health 

testing, visual inspections procedures, and phytosanitary field inspection 

procedures.. This review will be completed within 30 days. The information is 

then entered into the USDA-APHIS accreditation database. 

1.4.1.11 By submitting a signed application form, the applicant agrees to fulfill 

the accreditation procedure, specifically to receive the auditor team, to supply any 

information needed for the audit of the facility, and to pay in advance the fees 

charged to the applicant. These fees will cover the costs incurred in conducting 

the accreditation audits and include travel costs for the auditors. 

1.4.1.12 Once an application has been approved, the AM contacts the AU and 

requests that it arrange an audit within 30 working days after notification. If the 

audit cannot be performed within 30 days, the applicant is notified and another 

date is determined. 

1.4.2 Audit

 

1.4.2.1 The AU appoints a qualified auditor(s) to evaluate all material collected 

from the applicant and to conduct the audit on its behalf at the applicant’s location 

and any other sites where accreditation activities are to be performed. 

 

1.4.2.2 To ensure that a comprehensive and correct audit is completed, each 

auditor is provided with the appropriate working documents; auditor checklist 

templates are available from the AU. 

 

1.4.2.3 The date of audit is mutually agreed upon with the applicant. The latter is 

informed of the name(s) of the qualified auditor(s) nominated to perform the 

audit, with sufficient notice so that the applicant has an opportunity to appeal 

against the appointment of any particular auditor. 
23

 

1.4.2.4 The auditor(s) is formally appointed by the AM. A lead auditor is 

designated, if appropriate. The mandate given to the auditor(s) is clearly defined 

by the AM and forwarded to the applicant. 

 

1.4.3 Sub-contracting of Auditors

 

1.4.3.1 If the AU, with approval from the AM, decides to fully or partially 

delegate the audit of an applicant to another body, the AU takes full responsibility 

for such an audit made on its behalf. 

 

1.4.3.2 The AU ensures that any body to which an audit has been delegated is 

competent and complies with the applicable provisions of this document. 

1.4.4 Audit Report 

 

1.4.4.1 The AU may adopt reporting procedures that suit its needs but at a 

minimum these procedures ensure that: 

 

 a. A meeting takes place between the auditor(s) and the applicant prior to 

 leaving the facilities; the auditor provides a written or oral report on the 

 results of the audit; 

 

 b. The auditor(s) team provides the AU with a detailed report containing 

 all relevant information concerning the ability of the applicant to comply 

 with all of the accreditation requirements; and 

 

 c. A report on the outcome of the audit is promptly brought to the 

 applicant’s notice by the AM, identifying any non-compliance that must 

 be corrected in order to comply with all of the accreditation requirements. 

 The applicant is invited to present its comments on this report and to 

 describe the specific actions taken, or planned to be conducted (within a 

 time frame as specified by the AM), in order to remedy any non-

 compliance with the accreditation requirements. 

 

1.4.4.2 The final report is authorized by the AU and then submitted to the 

applicant, if different, and includes, at a minimum: 

 

 a. The date(s) of the audit(s); 

 

 b. The names of the auditor(s) that completed the report; 

 

 c. The names and addresses of all the facilities audited; 

 

 d. The scope of the audit of accreditation or reference thereto; and 

 
24

 e. The comments of the auditor(s) about the compliance of the applicant 

 with the accreditation requirements. 

 

1.4.4.3 The audit reports take the following into consideration: 

 

 a. The technical qualification, experience, education, and authority of the 

 staff encountered, particularly the persons responsible for the technical 

 validity of the laboratory seed health test reports. Technical qualifications 

 should also be noted for all staff preparing seed sampling reports and field 

 inspection reports, and for those reviewing seed reports; 

 

 b. The competency of the internal organization and the applicant’s adopted 

 procedures adequacy to give confidence to the quality of its services, and 

 physical facilities; 

 

 c. Proficiency testing of all accredited activities or other inter-laboratory 

 comparisons performed by the applicant, the results of the testing or 

 comparison, and the use of the results by the applicant; and 

 

 d. The actions taken to correct any non-compliance identified during 

 previous audits. 

 

1.4.5 Decision on Accreditation 

 

1.4.5.1 The decision whether or not to accredit an applicant is made by the AM on 

the basis of the information gathered during the accreditation process (this 

includes information received by all credible sources) and by the AU.

 

1.4.5.2 The AM does not delegate its responsibility for granting, maintaining, 

extending, suspending, or withdrawing accreditation. 

 

1.4.6 Documentation Granting Accreditation 

 

1.4.6.1 The AM transmits to each applicant formal accreditation documents such 

as a letter or a certificate signed by an officer who has been assigned this 

responsibility. These formal accreditation documents permit the identification of: 

 

 a. The name and address of the accredited applicant; 

 

 b. The scope of the accreditation including: 

 

 i. The type of accreditation granted (seed health testing, 

 phytosanitary field inspections, sampling for phytosanitary 

 testing, visual inspections); 

 

 ii. The crop species on which these test and inspections may be 
25

 carried out. 

 

 c. The persons recognized by the AM responsible for: supervising or 

 conducting the seed health laboratory tests, seed sampling procedures for 

 laboratory seed health testing, visual inspection procedures, and 

 phytosanitary field inspection procedures and that these persons have met 

 the appropriate qualifications and training requirements. 

 

 d. The effective date of accreditation, and the corresponding term, if 

 applicable. 

 

1.4.7 Re-Accreditation of AEs 

 

1.4.7.1 The AU has a program for carrying out re-accreditation audits and is 

performed every three years to ensure that the AE continues to comply with 

the accreditation requirements. 

 

1.4.7.2 The re-accreditation audit of the AE includes: 

 a. A report of activities and any internal audits (positive and negative 

 issues and suggestions) for the AU; 

 b. An updated Quality Manual for the AU, which would include any new 

 methods; and 

 c. An external audit. 

1.4.8 Certificates or Reports Issued by AE 

 

1.4.8.1 The AM normally allows an AE to refer to its accreditation in seed health 

test for reports that contain only the tests for which the AE is accredited. The AE 

refers to NSHS accreditation for use on certificates and documentation 

referencing accredited procedures only; specific language used may be referenced 

in the AE’s Quality Manual. Specific information regarding accreditated services 

for each AE is also listed on the USDA-APHIS NSHS website. The AE will not 

use NSHS attribution on any non-accredited services. Failure to comply with this 

requirement may result in the AE’s suspension of accreditation or indefinite 

expulsion from the NSHS program. 
26

SECTION TWO: Process of Accreditation. 

2.1 PURPOSE OF ACCREDITATION: 

2.1.1 Issuing Phytosanitary Certificates 

Provide a program where non-government entities and public entities are accredited to 

perform seed health laboratory test procedures, seed sampling procedures for laboratory 

seed health testing, visual inspection procedures, and phytosanitary field inspection 

procedures of seed crops for use in issuing phytosanitary certificates. 

 

2.1.2 Ensure Quality

Provide quality data for phytosanitary certifications through accreditation and quality 

assurance processes. 

 

2.1.3 Ensure High Performance Standards 

Maintain high standards of performance for testing and inspecting, ensuring movement of 

healthy seed within the U.S. and internationally. 

 

2.2 ACCREDITATION PROCEDURES 

 

2.2.1. Facility; Documentation and Staff Requirements

 

2.2.1.1 The applicant: 

 

a. Is organized in a manner to assure proficient: performance of seed health 

laboratory test procedures, seed sampling procedures for laboratory seed 

health testing, visual inspection procedures, and phytosanitary field inspection 

procedures; 

b. Has a Quality Manual or equivalent documentation to describe the Quality 

System; 

c. Is organized in a manner that avoids undue pressure or inducement possibly 

influencing judgment or results; 

 

d. Makes staff aware of specific job duties, including the extent and 

limitations of responsibilities; and 

 

e. Requires the technical manager to be sufficiently trained for tests and 

inspections. 

 

2.2.1.2 The facility and environment: 

 

 a. Conform to all local zoning and ordinances; 

 

 b. Provide a work area that is dedicated to laboratory function and is 
27

sufficiently removed (by physical barriers) from all residence(s) and food 

preparation areas; 

 

 c. Comply with all Federal and local regulations for chemical handling and 

disposal; 

 

 d. Provide a facility that does not invalidate the test results or adversely affect 

the accuracy of data; 

 

 e. Provide adequate protection from adverse environmental conditions (such 

as dust, contamination, temperature extremes, moisture extremes, etc.); 

 

 f. Are maintained to ensure "good housekeeping”; and 

g. Comply with all USDA-APHIS-PPQ requirements for the movement of 

regulated articles. 

 

2.2.1.3 Data reporting, records, and documents: 

 

a. Clearly state the results of the: seed health laboratory test procedures, seed 

sampling procedures for laboratory seed health testing, visual inspection 

procedures, and phytosanitary field inspection procedures, methodology, and 

other information pertinent to the results; 

b. Are maintained for a period that corresponds to the inventory of the 

product, and no less than three years and a statutory maximum; 

c. Are kept secure and are considered confidential, unless otherwise 

stipulated. 

2.2.1.4 Other records and documents include: 

 

 a. Records of equipment calibration and maintenance repair; and 

 

 b. All procedures, tests methods, and inspection methods. 

 

2.2.1.5 Samples and sampling records: 

 

 a. Sampling is according to NSHS sampling procedures in order to assure the 

sample is representative as listed in the reference manual. 

 

 b. Sampling is the responsibility of those authorized under state and Federal 

seed laws, or official sampling agents, and must be done in a manner suitable 

to assure adequate representation of the seed lot or plants. 

2.2.2. Facility Inspection Prior to Accreditation 
28

 

2.2.2.1 A registration audit is: 

 

a. Performed by a an approved NSHS auditor; and 

b. Verifies that resources (such as equipment and trained staff) are present 

and/ or in functioning order. 

2.2.2.2 Additional laboratory requirements: 

 

a. The laboratory utilizes Good Laboratory Practices (GLP) including, but not 

limited to: 

 

i. Aseptic techniques; 

 

ii. Identification of contamination potential and relevant containment 

procedures; 

 

iii. Sterilization and disinfestation of microbiological agents; and 

 

iv. Safe chemical handling and disposal procedures in accordance with 

Federal, State, and local laws and regulations as well as manufacturer 

guidelines. 

 

b. Equipment and machinery: 

 

i. Is required to correctly carry out the designated test; 

 

ii. Is properly maintained and repaired; 

 

iii. Is re-calibrated routinely or as necessary to correct erroneous results; 

 

iv. Contain calibration information that is logged as necessary or 

appropriate (pH meters, incubators, etc.).; and 

 

v. Contatin records of maintenance requirements, if relevant and they are 

current and accessible. 

 

c. Test methods and inspection protocols use approved methods and 

inspection protocols as listed in Reference Manual B. 

 

d. Other facility requirements include: 

 

i. Control of access to the testing area; and 

 

ii. Access only by persons subject to the rules of the testing and inspecting 
29

protocols. 

 

2.2.2.3 Staff and training requirements include: 

 

a. Appropriate education, training, technical knowledge, and experience for 

assigned functions is documented and clearly defined; and 

 

b. Evaluation of seed health tests and inspections are performed: by a 

University trained plant pathologist, under the supervision of a plant 

pathologist, or by a person with a related degree and with training approved 

by the AM. 

 

2.2.2.4 The Quality Manual or equivalent documentation outlines how the AE 

will: 

 

a. Ensure the accuracy and precision of all tests and data, document control, 

and sample control; 

b. Define the policy, purpose, and obligation of the AE; 

c. Document the quality for staff review; 

 

d. Document the structure/ facility; 

e. Document the operational staff and functional duties and responsibilities; 

 

f. Document all test procedures; 

 

g. Document all feedback and corrective actions; 

 

h. Define all customer complaint procedures; 

 

i. Document all procedures for new testing, including the assignment, as well 

as facility requirements prior to initiation; and 

j. Document the internal periodic audits of quality procedures. 

 

2.2.2.5 Documentation requirements for samples are outlined in Reference 

 Manual B. 

 

2.2.3 Accreditation Review and Post-accreditation Inspection 

 

2.2.3.1 The AE, after accreditation, provides periodic reports to the accrediting 

organization or an appointee of the organization. 

 

2.2.3.2 The AE faces the possibility of periodic accreditation review, in which all 
30

or part of the above documentation is reviewed by the AU and/or AM. 

 

2.2.3.3 Accreditation review is mandatory and/or the AE reports to the AU when: 

 

 a. Significant staff changes occur in technical or evaluating personnel; and 

 

 b. Significant errors occur in any referee sample tests. 

 

2.3 RELATIONSHIP BETWEEN THE NSHS AND THE APPLICANT OR 

ACCREDITED ENTITY 

 

2.3.1 General Provisions 

 

The administrators of the NSHS have arrangements to ensure that the applicant and its 

representatives afford such accommodation and cooperation as is necessary, to enable the 

accreditation body to verify compliance with the requirements for accreditation. These 

arrangements include provisions for examination of documentation and access to all 

testing areas, records, and personnel for the purpose of assessment, surveillance, 

proficiency testing, and complaints resolution. 

 

2.3.2 Specific Provisions 

 

The AM shall require that an AE: 

 

2.3.2.1 Maintains compliance with the relevant provisions of this document at all 

times; 

 

2.3.2.2 Make claims to be accredited only in terms of the services for which it has 

been granted accreditation and which are carried out in accordance with these 

conditions; 

 

2.3.2.3 Pays all fees determined by the AM; 

 

2.3.2.4 Abstains from using its accreditation in such a manner as to bring the 

 NSHS into disrepute and does not make any statement relevant to its accreditation 

 which the AM may consider misleading or otherwise unauthorized; 

 

 2.3.2.5 Discontinues its use of all advertising matter that contain any reference 

thereto and return any certificates of accreditation to the AU upon suspension or 

withdrawal of its accreditation; 

 

 2.3.2.6 Does not use its accreditation to imply product approval by the NSHS; 

 

2.3.2.7 Attempts to ensure that no certificate or report nor any part thereof is used 

in a misleading manner; and 

 
31

2.3.2.8 Complies with the requirements of the NSHS when making reference to 

its accreditation status in communication media such as advertising, brochures, or 

other documents. 

 

2.3.3 Notification of Changes 

 

2.3.3.1 The AU makes arrangements to ensure that an AE provides notification 

immediately for any change in any aspect of the AE’s status or operation affecting 

the AE’s: 

 

 a. Legal, commercial, or organizational status; 

 

 b. Organization and management (e.g., key managerial staff); 

 

 c. Policies or procedures, where appropriate; 

 

 d. Facilities (any premises involved in accredited activities); 

 

 e. Personnel, equipment, facilities, working environment, or other 

 resources, where significant; and 

 

 f. Authorized signatories; or 

 g. Other issues affecting the laboratory's capability, scope of accredited 

 activities, or compliance with the requirements in this document; or any 

 other relevant competence criteria specified by the AM. 

 

2.3.3.2 Upon receipt of a notice of any intended changes relating to the 

requirements of this document, the relevant competence criteria, and any other 

requirements specified by the AM, the AU shall ensure that the AE carries out 

any necessary procedural changes within a timeframe designated by the AM. The 

AE will notify the AU when such adjustments have been made. 

 

2.3.4 Directory of AEs

 

The AM produces an annual directory of AEs describing any accreditation granted. 

 
32

SECTION THREE: Evaluation and screening of laboratory seed heath 

testing, seed sampling, visual inspections, and phytosanitary field 

inspections methodologies 

 

3.1 CRITERIA FOR THE EVALUATION OF LABORATORY SEED HEALTH 

TESTING METHODOLOGIES;

EVALUATION PROCEDURES

 

3.1.1 A Review of Test Methods is Conducted by the AU and Includes: 

 

 3.1.1.1 A literature review of the host/pathogen interactions and a compilation of 

 the published interactions and detection methods; 

3.1.1.2 A compilation of unpublished laboratory seed health tests currently in use; 

and 

3.1.1.3 A compilation of proprietary methodologies, if so offered for evaluation 

by the owner. The evaluation of proprietary methodologies is governed by a 

confidentiality agreement. 

 

A list is made of all methods found with a brief description of each method (i.e. cultural, 

serological, etc.), and the literature citation, if available. Proprietary methods are noted. 

3.1.2 Elimination of Methodologies 

The AU eliminates those laboratory methodologies it judges to be unfit, irrelevant, or out 

of date. 

 

3.1.3 AU Communication to Panel Members 

The AU forwards to each panel member a description of all laboratory seed health tests. 

Included in this description are all relevant scientific documentation on the test 

development and record of use (if any) as routine tests. 

 

 3.1.3.1 Panel Responsibilities 

 

 It is the responsibility of panel members to evaluate the information provided 

 based upon the following criteria: 

 

 a. Criterion 1. Empirical Test Data 

 These are suggested parameters for establishment of a laboratory seed 

 health test from published information. New techniques will have the 

 following parameters included in the development process: 
33

 i. Sensitivity. Determine how sensitive the assay is in terms of 

 either percent-infected seed or target pathogen quantification, such 

 as CFU, number of conidia, etc. Panel members may need to make 

 an arbitrary determination about whether the methodology in 

 question is sensitive enough, or they will make a recommendation 

 that the test requires further work. The panel members should also 

 make recommendations on sample size if this is not clearly spelled 

 out in the existing procedures for that test. 

 

 ii. Specificity. Determine whether the assay is capable of detecting 

 a range of isolates of the pathogen from different geographical 

 regions, races, etc. Determine whether other closely related 

 organisms are separated with the technique. 

 iii. Repeatability and Reliability. Replicate experiments of 1 and 2 

 help determine these parameters. Additional experimentation 

 including varying types of seed samples (varieties, production 

 areas, etc.) will further refine these parameters. 

 b. Criterion 2. Internal Comparative Data 

 Comparisons with already established techniques will yield useful 

 information regarding new techniques. If a new technique performs as 

 well or better than an established technique then it should be accepted. 

 This information is generated internally through the developmental 

 process or through group comparative testing. These criteria may be of 

 limited applicability to panel members evaluating existing test 

 methodologies. 

 

 c. Criterion 3. Historical Data 

 If a technique has been used in industry or academia there may be some 

 indication or record of the number of uses of that technique. In 

 commercial use there may also be a record of the number of complaints 

 associated with a particular assay. These records may be a good indicator 

 of the effectiveness of the assay, and if available will be reviewed. 

 

 3.1.3.2 Other Criteria 

 Panel members will consider any other criteria that might have significant 

 impact on the recommendation for use of a test. These include the cost of 

 the test, facilities required to perform it, time to perform test, and other 

 factors. 

3.1.4 Panel Report 

 

The Technical Panel prepares a report rating each of the various methodologies evaluated 

by these criteria listed above and states the reason(s) for their rating. The report also 

includes panel recommendations on any improvements that should be made to any aspect 
34

of the process. 

 

The panel members use the following guidelines for rating the methodology(s): 

 

3.1.4.1 Class A. The test or method acceptable as a standard test; 

 

3.1.4.2 Class B. The test or method needs further research before acceptance as a 

 standard test. This could be for improvement to the method itself or a 

 recommendation for a comparative test with a known method; or 

3.1.4.2 Class C. The test should not be accepted as a standard test. 

3.2 CRITERIA FOR THE EVALUATION OF PHYTOSANITARY FIELD 

INSPECTION METHODOLOGIES 

A review of new seed crop field inspection methodologies will be conducted by the 

PPAB and may be referred to a Technical Panel if the proposed method differs from the 

procedure for Seed Crop Field Inspection listed in Reference Manual B. 

See Reference Manual B for the Seed Crop Field Inspection procedure. This includes a 

detailed strategy for inspecting fields and diagnosing diseases (both in the field and in the 

laboratory). 

3.3 CRITERIA FOR THE EVALUATION OF SAMPLING PROCEDURES

The PPAB has voted to use the AASCO Handbook on Seed Sampling 

(http://www.seedcontrol.org/seed_sampling_handbook.html) for its seed sampling 

methodology for phytosanitary seed health testing for the NSHS. This is in accordance 

with current State and Federal visual inspection policy. 

3.4 CRITERIA FOR THE EVALUATION OF VISUAL INSPECTION 

METHODOLOGIES 

The PPAB has voted to use the “General Procedures: Inspecting Commodities” section 

from the USDA Export Program Manual (XPM) 

(http://www.aphis.usda.gov/import_export/plants/manuals/domestic/downloads/xpm_pdf

/3_5genproc_inspecting_commods.pdf) for its visual inspection methodology for the 

NSHS. This is in accordance with current State and Federal visual inspection policy. 
35

GLOSSARY OF TERMS 

 

Accredited Entity (AE): An entity, which has been accredited by the USDA-APHIS to 

perform laboratory seed health tests or phytosanitary inspections in support of 

phytosanitary certification. 

 

Accreditation Candidate (or Applicant): An entity from which an application form and 

appropriate fees has been accepted by the USDA-APHIS. 

Accreditation Manager (AM): An officer of the USDA-APHIS appointed by the 

Administrator of APHIS to administer and direct the accreditation of entities to perform 

seed health laboratory test procedures, seed sampling procedures for laboratory seed 

health testing, visual inspections procedures, and phytosanitary field inspection 

procedures. 

Administration Unit (AU): An organization authorized by the USDA-APHIS to perform 

specific functions involving the evaluation of applicants for accreditation as well as 

managing the administrative, technical, and scientific aspects of the NSHS. Iowa State 

University Seed Science Center was designated as the AU at the inception of the NSHS 

in 2001. Other AU will be designated as well, if needed. 

American Seed Trade Association (ASTA): A trade organization with membership 

consisting of about 850 companies involved in seed production and distribution, plant 

breeding, and related industries in North America. This group has three members on the 

PPAB, one of which is the Chair. http://www.amseed.com/ 

Association of American Seed Control Officials (AASCO): An organization of seed 

regulatory officials from the United States and Canada that works to achieve uniformity 

of seed legislation between member states and Federal agencies. This group has one 

member on the PPAB. http://www.seedcontrol.org/index.html 

Association of Official Seed Certifying Agencies (AOSCA): A group of seed certifying 

agencies and foundation seed organizations that work on production, identification, 

distribution, and promotion of certified classes of seed and other crop propagation 

materials. This group has one member on the PPAB. http://www.aosca.org/

Authorized Certification Official (ACO): Any Federal, state, or local government 

official authorized by the USDA-APHIS to issue Federal phytosanitary certificates.

Entity: Any organization, company, limited partnership, corporation, association, 

individual, or any other legally constituted entity, whether in the private or public sector 

who wishes to provide services to the seed industry in support of phytosanitary 

certification. 

International Seed Health Initiative (ISHI): An initiative that works on seed health 

issues under the International Seed Federation. 
36

http://www.worldseed.org/en-us/international_seed/seed_health_testing.html 

International Seed Testing Association (ISTA): An international seed organization 

that works on developing, adopting, and publishing standard procedures for sampling and 

testing seeds, and promoting uniform application of these procedures for evaluation of 

seeds moving in international trade. 

http://www.seedtest.org/en/home.html 

Minor Use Crops: Host/pathogen combinations that are tested for so infrequently that 

forming Technical Panels to approve methods is not reasonable. 

National Plant Board (NPB): A non-profit organization of the plant pest regulatory 

agencies of each of the states and Commonwealth of Puerto Rico. Membership of the 

NPB is made up of the principal plant pest regulatory officials of each state. They inspect 

plants and commodities for export so that required phytosanitary certification can be 

provided. This group has one member on the PPAB. 

 

National Seed Health System (NSHS): A cooperative government and industry 

consortium formed to address seed health and trade problems in an orderly, scientific and 

systematic manner. The goal is optimal trade while protecting agriculture, the 

environment, and the economic well being of the interested and affected parties. The 

consortium is composed of participants from NPB, AASCO, AOSCA, ASTA, and with 

ex-officio membership of the Administrator of APHIS and the director of the AU. 

The Policy and Procedures Advisory Board (PPAB): The primary body giving 

direction to the NSHS. The PPAB will contain one member each from NPB, AASCO, 

AOSCA, and three members from ASTA. The director(s) of the AU(s) and the 

Administrator of APHIS (or his designee) will participate as ex-officio members of the 

PPAB. 

Quality Manual: A document that includes or makes reference to the quality system 

procedures and outlines the structure of the documentation used in the quality system. 

The Quality Manual is only a general outline. Specific procedures are reserved for 

detailed work instructions and reference materials such as laboratory procedures, 

manuals, etc. 

 

Reference Manual A (RM-A): Reference Manual for Procedures and Policies of the 

National Seed Health System. RM-A describes the structure, administration, procedures, 

policies, and working practices of both the Seed Health Accreditation Program and the 

NSHS. The manual also contains the relevant documentation, forms and references for 

the NSHS. (RM-A will be accessible on the USDA-APHIS web site.) 

 

Reference Manual B (RM-B): Reference Manual for Laboratory Test and Phytosanitary 

Inspection Methodologies of the National Seed Health System. RM-B contains the 

detailed seed health testing, seed sampling, and phytosanitary inspection procedures for 
37

the NSHS. (RM-B will be publicly accessible on the USDA-APHIS web site.) 

 

 

 
38

REFERENCES: 

 

ANSI/ASQC Q9001-1994: 

American National Standard: Quality Systems-Model for Quality Assurance in Design, 

Development, Production, Installation and Servicing. American Society for Quality 

Control, 1994.

IPPC, 2001 

International Standards for Phytosanitary Measures 12: Guidelines for phytosanitary 

certificates. 

https://www.ippc.int/servlet/BinaryDownloaderServlet/16199_ISPM_12_E.pdf?filename

=1146658528409_ISPM12.pdf&refID=16199 

NAPPO, 2004 

Regional Standards for Phytosanitary Measures No. 9: The Accreditation of Laboratories 

for Phytosanitary Testing. http://www.nappo.org/Standards/REVIEW/RSPM%20No9-

e.pdf 

NAPPO, 2009 

Regional Standards for Phytosanitary Measures No. 5: NAPPO Glossary of 

Phytosanitary Terms. http://www.nappo.org/Standards/REVIEW/2009/RSPMNo.5Rev02-02-09-e.pdf

 

 

 
39

APPENDIX A:

Quality System and the Quality Manual 

 

The Requirement for a Quality Manual is stated in: 7 CFR Part 353.8 Accreditation of 

non-government facilities. 

 

(b)(3)(iii) Methods of testing or inspection. The facility must have a quality 

manual or equivalent documentation that describes the system in place at the 

facility for the conduct of 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 used 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. 

 

 The key requirement listed here is: “...a quality manual or equivalent documentation 

that describes the system...” 

 

For the purposes of assessment and accreditation the NSHS requires that an applicant 

satisfy the appropriate elements in order to receive accreditation. These 20 elements for 

consideration are listed below. Only those elements relevant to the applicant’s 

registration need to be addressed in the Quality Manual or equivalent documentation 

describing the system. The applicant may be asked to show why certain elements are not 

relevant during the registration audit. 

 

1. Management responsibility 

2. Quality system 

3. Contract review 

4. Design control 

5. Document and data control 

6. Purchasing 

7. Control of customer supplied product 

8. Product identification and traceability 

9. Process control 

10. Inspection and testing 

11. Control of inspection, measuring, and test equipment 

12. Inspection and test status 

13. Control of non-conforming product 

14. Corrective and preventative action 

15. Handling, storage, packaging, preservation, and delivery 

16. Control of quality records 

17. Internal quality audits 

18. Training 

19. Servicing 

20. Statistical techniques 
40

1. Management Responsibility 

The AE designates managers responsible for the system and defines and documents the 

quality policy of the system. 

 

2. Quality System 

The AE establishes, documents, and maintains a quality system as a means of ensuring 

that a product (or service) conforms to specified requirements. The AE maintains a 

quality manual or equivalent documentation that includes or makes reference to the 

quality-system procedures and also outlines the structure and documentation used in the 

system. 

 

3. Contract Review 

 

The AE establishes and maintains documented procedures for contact review. The 

contracts are those with customers specifying the requirements of the service or product 

being supplied and indicating\the supplier has the capability of meeting those 

requirements. 

 

4. Design Control 

 

The AE establishes and maintains documented procedures to control and verify the 

design of the product or service to ensure that all specified requirements are met. 

 

5. Document and Data Control 

The AE establishes and maintains documented procedures to control all documents and 

data relating to the requirements of the NSHS, including where applicable, external 

documents such as standards and other customer-supplied documents and drawings (i.e., 

field maps). 

 

6. Purchasing 

 

The AE establishes and maintains documented procedures to ensure that all purchased 

products conform to specified requirements. This control is required to assure that 

substitutions, especially of laboratory supplies, meet the same standards of quality 

(performance) as those products specified in the lab procedures or methodologies. 

 

7. Control of Customer Supplied Product 

 

The AE establishes and maintains documented procedures for the control of verification, 

storage, and maintenance of all customer-supplied products incorporated into supplies 

(either supplied products or services) or for related activities. Verification of the AE does 

not release the customer of the responsibility to provide an acceptable product. 
41

 

For the most part, this would refer to the maintenance of samples. It also requires the 

customer (the AE contracted for testing/inspection service) to provide a proper sample 

and/ or appropriate field documentation/ maps for inspection purposes. 

 

8. Product Identification and Traceability 

The AE’s product is also data. The AE has a system for controlling that product (data) 

throughout the entire process of production and development. The system for tracing the 

product is documented and maintained. 

 

9. Process Control 

 

The supplier identifies and plans production, installation, and servicing processes that 

directly affect quality and ensures that these processes are carried out under controlled 

conditions. 

 

In other words, the AE abides by the appropriate standards, whether Good Laboratory 

Practices (GLP), lab methodologies, field inspection practices, or other and also 

documents this process. This is the portion of the Quality Manual where standards, lab 

methodologies, work instructions, and other references are assembled and result in 

quality records or data. 

 

10. Inspection and Testing 

 

The supplier establishes and maintains documented procedures for inspection and testing 

activities in order to verify that the specific requirements for the product are met. The 

required inspection and testing, and the record to be established, are detailed in the 

quality plan or other documented procedures. 

 

Seed samples are inspected to ensure they meet the requirements for testing. The testing 

process itself is subject to inspection and testing to ensure that the test is being properly 

performed. Similarly, fields must be “inspected prior to seed inspection” to ensure that 

they are in the proper condition (i.e., stage of development) for the requested seed 

inspection. If access to a field is not possible for any reason (i.e., flood, tornado, chemical 

application, etc.) it should not be inspected. 

 

11. Control of Inspection, Measuring, and Test Equipment 

The supplier establishes and maintains documented procedures to control, calibrate, and 

maintain inspection, measuring, and test equipment. 

 

12. Inspection and Test Status 

The product’s inspection and test status is identified by suitable methods to ensure that 

only a product which has passed the required inspections and tests is dispatched, used, or 
42

installed. 

 

Test results are not issued until the relevant verification (i.e., inspection or test of the 

data) has been made and the data is determined to be correct. Similarly, field inspection 

reports are not issued until samples have been evaluated. 

 

13. Control of Non-Conforming Product 

The supplier establishes a maintained and documented procedure to ensure that product 

that does not conform to specified requirements is prevented from unintended use or 

installation. 

 

Data from improperly performed tests or field inspections may not be issued to the 

customer. 

 

14. Corrective and Preventive Action 

 

The AE establishes and maintains documented procedures for implementing corrective 

and preventive action. If the testing or inspection process cannot be performed as 

outlined, the AE must document the process required to overcome any problem. If this 

requires a revision of testing and inspection methodologies, these processes may be 

subject to review by a technical panel prior to incorporation into the accepted 

methodologies and procedures. 

 

15. Handling, Storage, Packaging, Preservation, and Delivery 

 

There is an established and documented procedure for delivering data to customers. 

 

16. Control of Quality Records 

 

The supplier maintains documented procedures for identification, collection, indexing, 

access, filing, storage, maintenance, and disposition of quality records. Quality records 

are maintained to demonstrate conformance to specified requirements and effective 

operation of the quality system. 

 

17. Internal Quality Audits 

The supplier establishes and maintains documented procedures for planning and 

implementing internal quality audits to verify whether quality activities and related 

results comply with planned arrangements and to determine the effectiveness of the 

quality system. 

 

18. Training 

The AE establishes and maintains documented procedures for identifying training needs 

and provides for the training of all personnel performing activities affecting quality. 
43

Personnel performing specific assigned tasks are qualified on the basis of appropriate 

education, training, and/ or experience, as required. Appropriate records of training are 

maintained. 

 

19. Servicing 

 

When servicing is a specified requirement, the AE establishes and maintains documented 

procedures for performing, verifying, and reporting that the servicing meets the specified 

requirements. 

 

20. Statistical Techniques 

 

The supplier identifies the need for statistical techniques required for establishing, 

controlling, and verifying process capability and product characteristics, and also 

establishes and maintains documented procedures to implement and control the 

application of the statistical technique identified. 

 

RM-A_102009.doc