Attachment_1_(ISO_Statement_of_Work_FY16).pdf

16-223-SOL-00099 Page 1 of 7 Attachment 1

Statement of Work

Maintenance of a Technical Advisory Group for United States Representation on International Organization for Standardization (ISO) Technical Committee 34 Subcommittee 9

BACKGROUND

The purpose of this contract is to maintain and support a technical advisory group (TAG) that was established in 2011 which will continue to represent the United States on the International Organization for Standardization’s (ISO) Technical Committee 34 (TC 34) Subcommittee 9 (SC 9). ISO is an international non-governmental organization, based in Geneva, Switzerland, that is a network of 163 national standards institutes including the American National Standards Institute (ANSI) whose headquarters are located in Washington, DC. ISO’s mission is to provide “International Standards for Business, Government and Society.” A central role of ISO is to make trade between countries easier and fairer by harmonizing standards among nations. For example, ISO 17025:2005 (General requirements for the competence of testing and calibration laboratories) specifies the general competencies that microbiological and chemical testing laboratories must possess in order to be considered reliable for food testing. FDA laboratories are ISO 17025:2005 certified, as are the vast majority of regulatory laboratories around the world. This certification allows for a certain level of trust and confidence that would otherwise not be available if there were no common standards.

ISO methods are internationally recognized and have a significant impact on trade. For example, ISO methods are recognized by organizations such as the European Committee for Standardization (CEN) which is comprised of the 31 member states of the European Union (EU).

As enunciated by the CEN on its website (http://www.cen.eu/cen/AboutUs/Pages/default.aspx):

“These standards have a unique status since they also are national standards in each of its 31 Member countries. With one common standard in all these countries and every conflicting national standard withdrawn, a product can reach a far wider market with much lower development and testing costs. European Standards help build a European Internal Market for goods and services and position Europe in the global economy. More than 60.000 technical experts as well as business federations, consumer and other societal interest organizations are involved in the CEN network that reaches over 480 million people.” The Vienna Agreement − signed by CEN in 1991 with ISO, its international counterpart − ensures technical cooperation by correspondence, mutual representation at meetings, coordination meetings, and adoption of the same text, as both an ISO Standard and as a European Standard. Thus, ISO methods, including those for food microbiology, are the official reference methods of the EU and all of its member states.

http://www.cen.eu/cen/AboutUs/Pages/default.aspx http://www.iso.org/

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ISO has an important and significant role in the standardization of food microbiological testing methods. It exercises this role through TC 34/SC 9. TC 34 is responsible for the international standards of “Food Products” and SC 9 is specifically responsible for food microbiology. SC 9 is comprised of 30 participating/voting nations and 24 observing/non-voting nations, as well as 14 liaison non-governmental organizations. These liaison organizations include, but are not limited to, AOAC International, International Commission of Microbiological Specifications for Foods, and the World Health Organization. TC 34/SC 9 is responsible for 62 standards. TC 34/SC 9 has a working group (WG) structure whereby standards are developed and validated (http://www.iso.org/iso/iso_technical_committee?commid=47920). Microbiological standards or methods, under the purview of TC 34/SC 9, include those for pathogens such as Salmonella (ISO 6579:2002), Listeria monocytogenes (ISO 11290, parts 1 and 2), and E. coli O157:H7 (ISO 16654:2001) to name a few. All food microbiological methods relevant to the FDA arise from

TC 34/SC 9.

The United States is currently a participating nation on ISO TC 34/SC 9 and its TAG is currently administered by ANSI (HHSF223201110106C). The United States currently convenes (leads) 5 of the 26 active WGs: WG 13, Enumeration of coagulase positive staphylococci using BP agar;

WG 16, Yeasts and Molds; WG 24, Detection of Shigella; WG 25, Whole-genome sequencing for typing and genomic characterization; and, WG 26, Detection of Clostridium botulinum toxins. In addition to leading these 5 working groups, the United States TAG has representation on most of the other WGs. This gives the U.S. official input regarding the adoption of microbiological testing methods for foods for which its public health and trade interests are at stake.

OBJECTIVE

The intent of this statement of work is to continue to provide the United States with representation on ISO TC 34/SC 9. The United States TAG to TC 34/SC9 represents the interests of the United States and is composed of representatives from government, industry and academia who arrive at consensus positions regarding their areas of expertise. Members of US TAG for TC 34/SC 9 will continue, with the support of their organizations, to participate in working groups that will develop and validate microbiological methods for the detection of bacterial pathogens in foods. Continued support of this TAG will continue provide the US with a vote on TC 34/SC 9 and will enable the US to officially share its knowledge and resources in the development and validation of ISO reference methods. Support of this TAG will advance FDA’s public health mission by allowing it, as an active participant, to ensure the accuracy and reliability of ISO reference methods. Having accurate and reliable ISO reference methods is a key step in making imported foods safer for US consumers.

http://www.iso.org/iso/iso_technical_committee?commid=47920

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SCOPE OF WORK

The contractor tasks include:

1.0 Direct Administration of the US TAG for ISO TC 34/ SC 9

• Continued approval by ANSI of the TAG administrator and the current TAG membership list and accreditation of the TAG.

• Submission of the US TAG membership list and annual report to ANSI for review by the

Executive Standards Council (ExSC) or its designee.

• Ensure an active membership of the US TAG by monitoring their participation.

• Provide administrative services, including arrangements for meetings, timely preparation and distribution of documents related to the work of the US TAG, and maintenance of appropriate records, including meetings minutes and results of letter ballots.

• Provide administrative support to the Working Groups where a United States TAG member is the convener of the Working Group.

• Transmission US proposals and US positions, as developed and approved by the US TAG to ANSI.

• Transmission of US delegate lists for all international meetings to ANSI.

• Establish a procedure to hear appeals of actions or inactions of the US TAG.

• Complying with the requirements associated with ANSI oversight and supervision of the activities of the U.S. TAG and its administrator in accordance with ANSI International Procedures clause 2.5.

• Ensure compliance with applicable ANSI and ISO procedures.

2.0 CONTRACTOR’S TECHNICAL WORKPLAN

• Maintain the TAG membership list. This includes both soliciting participation on the TAG and ensuring that the membership is active by monitoring their participation.

• Provide administrative services, including arrangements for meetings, timely preparation and distribution of documents related to the work of the US TAG, and maintenance of appropriate records, including meetings minutes and results of letter ballots.

• Provide administrative support to the Working Groups where a United States TAG member is the convener of the Working Group.

• Transmit US proposals and US positions, as developed and approved by the US TAG to

ANSI.

• Transmit US delegate list for all international meetings to ANSI.

• Establish a procedure, with input from the project officer, to hear appeals of actions or inactions of the US TAG.

• Ensure compliance with applicable ANSI and ISO procedures.

• Ensure compliance with the requirements associated with ANSI oversight and supervision of the activities of the U.S. TAG and its administrator in accordance with ANSI International Procedures clause 2.5 (prescribed below under SPECIAL

REQUIREMENTS).

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SPECIAL REQUIREMENTS

2.5 Accreditation of U.S. TAGs

2.5.1 General. U.S. TAGs shall be accredited by ANSI and must operate in compliance with the ANSI Criteria for the Development and Coordination of U.S. Positions in the International Standardization Activities of the ISO and IEC.

2.5.2 Criteria for Accreditation. U.S. TAG accreditation shall be based on compliance with the following criteria:

1. The U.S. TAG is in compliance with the criteria for balance and openness as outlined in sections B4.1 and B4.2 of the ANSI Criteria for the Development and Coordination of U.S. Positions in the International Standardization Activities of the ISO and IEC (see Annex B)

2. The U.S. TAG operating procedures for developing and coordinating U.S. positions shall conform to the requirements of the ANSI Criteria for the Development and Coordination of U.S.

Positions in the International Standardization Activities of the ISO and IEC (see Annex B)

3. The U.S. TAG administrator shall agree to assume the functions given in section 2.3.3.

2.5.3 Application. The prospective U.S. TAG administrator shall submit an application to ANSI for U.S. TAG accreditation as well as an application for approval of the U.S. TAG administrator and the U.S. TAG membership list and shall provide the pertinent operating procedures.

Following the public review period the ExSC shall consider the information supplied by its designee if any, the applicant, and any comments received. The ExSC shall determine whether the application for accreditation of the U.S. TAG, the application for approval as U.S. TAG administrator, and the initial U.S. TAG membership list should be approved. The applicant shall meet all of the criteria in section 2.5.2 before accreditation can be granted. If there is no designee, the application for approval of the U.S. TAG administrator and the U.S. TAG membership list and the application for accreditation shall be forwarded directly to the ExSC. Upon accreditation, the applicant shall be notified and a notice shall appear in Standards Action.

In the event that accreditation is not granted, the ExSC shall advise the applicant of the reasons and the applicant shall have the opportunity to reapply and, if desired, appeal the decision (see 2.6.)

2.5.4 Accreditation of U.S. TAGs for Subcommittees of ISO Technical Committees. If a U.S. TAG to an ISO subcommittee has the authority to perform all of the functions of a U.S. TAG as outlined in section 2.2.3 without oversight by the U.S. TAG to the ISO technical committee, then the U.S. TAG for the ISO subcommittee shall be accredited in accordance with sections 2.4 and 2.5 of these procedures.

2.5.5 Maintenance of Accreditation. The ExSC shall provide for oversight and supervision of accredited U.S. TAGs and TAG administrators to confirm adherence to the criteria for accreditation and to confirm that the procedures and practices of the accredited U.S. TAG continue to be consistent with those that formed the basis for accreditation. This oversight and supervision activity shall apply to all U.S. TAGs regardless of whether an external organization or ANSI serves as U.S. TAG administrator. The activity shall consist of the following elements, designed to achieve the objectives while minimizing the burden on U.S. TAGs and U.S. TAG administrators.

2.5.5.1 Review of Revisions to U.S. TAG Procedures. The procedures of the U.S. TAG shall be in Compliance with the ANSI International Procedures at all times. Whenever the procedures of the accredited U.S. TAG are revised, the ExSC shall be notified. If the changes are considered by the ExSC to be substantive, notice of the revisions shall appear in Standards Action with a call for comment. Copies of the revised procedures shall be available from the U.S. TAG administrator upon request.

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Following the comment period, the ExSC shall consider the comments received, the latest audit of the accredited U.S. TAG, and any additional information available to determine whether to reaffirm the accreditation. Notice of reaffirmation shall be sent to the accredited U.S. TAG and shall appear in Standards Action.

2.5.5.2 Annual Reporting. An annual report shall be prepared by each U.S. TAG administrator, describing in summary narrative form the U.S. TAG activity during the past year. The report shall be submitted to the ExSC or its designee no later than January 31 of the following year. In satisfying this requirement, meeting minutes and other appropriate reports and documents may be incorporated or appended, or referred to if previously distributed by ANSI. The annual report shall include:

1. Information on meetings (including attendees), actions taken, and the work program

2. Current TAG membership list which shall include:

a) Title and designation of the U.S. TAG

b) Scope of the U.S. TAG

c) U.S. TAG administrator (name of organization, name of secretary, address(es), telephone number)

d) U.S. TAG officers (chairman and other officers)

e) Members:

i) Names of the individuals and alternates (as applicable) and their addresses and business affiliations including names of the organizations they are representing on the U.S.

TAG

ii) The interest categories of the U.S. TAG shall be defined and the category of each member identified

3. A list of any problems encountered during the past year in the functioning of the U.S. TAG or U.S.

TAG administration, and any areas in which the U.S. TAG administrator requires assistance by ANSI

4. An express certification by the U.S. TAG administrator that the U.S. TAG has been and continues to be operated in a manner that complies with all applicable ANSI and ISO procedures

5. The results of any self-audit held during the past year

If the U.S. TAG or TAG Administrator has a concern with either the conduct or results of a self-audit completed to assure adherence to its own procedures and applicable ANSI and ISO criteria and procedures, it may be brought to the attention of the ExSC.

2.5.5.3 Complaint Notification. Each U.S. TAG administrator shall forward to the ExSC or its designee, upon receipt, a copy of any complaint concerning the manner in which the U.S. TAG is operating or the U.S. TAG administration is being conducted. Copies of the U.S. TAG administrator response to the party lodging the complaint, and all subsequent related correspondence, shall also be sent to the ExSC or its designee.

2.5.5.4 ANSI Audits. The ExSC on its own initiative, or upon recommendation from a designee, shall arrange for audits of accredited U.S. TAGs and TAG administrators at selected intervals commensurate with the level of activity of each U.S. TAG and evidence of compliance with procedural rules and other requirements. The purpose of such audits is to validate the U.S. TAG’s annual certification that it is operating according to applicable ANSI and ISO procedures, and to identify areas where ANSI can help the U.S. TAG improve its operation. The audit will examine:

1. Procedures in use by the U.S. TAG governing the development of U.S. positions

2. Knowledge of and compliance with ISO and ANSI requirements

3. Records of compliance and their maintenance

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4. Adherence to ANSI due process and consensus criteria

5. Balloting procedures and results

6. Documentation of attempts to resolve objections

7. Appeal mechanism and its implementation

An audit report shall be prepared and provided to the U.S. TAG administrator for review. Thereafter the report and comment by the U.S. TAG and TAG administrator, if any, shall be submitted to the ExSC. The ExSC shall take appropriate actions with respect to the audit findings, which may range from commendation to a request for remedial action by the U.S. TAG or TAG administrator.

ANSI representatives shall assist the U.S. TAG and TAG administrator regarding any corrective steps found desirable.

2.5.5.5 Transfer of U.S. TAG Administrator. In those instances where a U.S. TAG administrator is unable to continue serving, ANSI shall be notified immediately. If a change in the entity that serves as the TAG Administrator is sought by both the TAG and the TAG Administrator and the new TAG Administrator agrees to use the TAG’s existing procedures or the Model Operating Procedures for U.S. TAGs to ANSI for ISO Activities contained in Annex A, then the following shall apply:

(a) The current or the proposed TAG Administrator shall prepare and circulate a ballot for TAG approval of the new TAG Administrator.

(b) Upon closure of the ballot, a copy of the voting results shall be transmitted to the TAG pursuant to the TAG’s currently accredited procedures:

• If a two-thirds affirmative vote of the total voting membership of the TAG, excluding abstentions, is not achieved, and the TAG Administrator does not wish to continue to serve, then the ExSC shall be so notified in writing. The accreditation of the TAG shall be withdrawn by the ExSC as a result in accordance with 2.5.6 herein.

• If a two-thirds affirmative vote of the total voting membership of the TAG, excluding abstentions, is achieved, then the following procedures shall apply.

(c) A notice shall be sent to the Secretary of the ExSC notifying it of the change in TAG Administrator, the reasons therefore, a copy of the voting results that indicate the TAG’s acceptance of the proposed change and a certification that the new TAG Administrator shall operate in accordance with the TAG’s currently accredited procedures or the Model Operating Procedures for U.S. TAGs to ANSI for ISO Activities.

(d) The Secretary of the ExSC shall place an announcement of the transfer of responsibility to the new TAG Administrator in Standards Action to solicit public comment. The comment period shall be 30 days.

(e) The ExSC shall consider any comments received during the public comment period. If no comments are received, then an informative announcement confirming the change of TAG Administrator shall be made in Standards Action. If comments are received, the ExSC shall require that the TAG and the proposed new TAG Administrator respond adequately to such comments prior to final approval by the ExSC.

2.5.5.6 Termination of U.S. TAG. A proposal to terminate a U.S. TAG may be made by directly and materially affected interests. The proposal shall be submitted in writing to ANSI and to the U.S.

TAG administrator and shall include the reasons why the U.S. TAG should be terminated. The U.S.

TAG in accordance with A7.6 shall take action. In the event that the U.S. holds the secretariat for a ISO TC or SC for which the U.S. TAG is considering termination, the organization serving as

16-223-SOL-00099 Page 7 of 7 secretariat shall be informed promptly and shall submit their position regarding termination of the TAG to ANSI and to the TAG administrator.

As a result of action taken in accordance with A7.6, if termination of the TAG is approved, notification of such action shall be announced in Standards Action. The announcement shall note that dissolution of the TAG will result in the U.S. relinquishing its P- (participant) status in the international activity.

Also, if the U.S. serves as international secretariat, the announcement shall state that the U.S. will resign as international secretariat. The appropriate notification(s) shall be sent to ISO regarding the change in status, and the relinquishment of the secretariat, if applicable.

PERIOD OF PERFORMANCE

The period of performance for this statement of work is Base Period September 1, 2016 to August 31, 2017 Option Period 1 September 1, 2017 to August 31, 2018 Option Period 2 September 1, 2018 to August 31, 2019 Option Period 3 September 1, 2019 to August 31, 2020 Option Period 4 September 1, 2020 to August 31, 2021

PLACE OF PERFORMANCE

The preponderance of work will be performed at the contractor’s location, though domestic and international travel may be required.

The purpose of this contract is to maintain and support a technical advisory group (TAG) that was established in 2011 which will continue to represent the United States on the International Organization for Standardization’s (ISO) Technical Committee ...