3A Procedures Development Maintenance Standards Accepted Practices 9-13-2021

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3-A Sanitary Standards, Inc.

Procedures for the Development and


Maintenance of 3-A SSI Standards
and 3-A Accepted Practices
3-A SSI Steering Committee Approved: September 13, 2021

3-A Sanitary Standards, Inc.


6888 Elm Street, Suite 2D
McLean, Virginia 22101
Phone: 703-790-0295
FAX: 703-761-6284
Email: [email protected]
Web address: www.3-a.org
Procedures for the Development and Maintenance of 3-A SSI Standards and 3-A Accepted Practices

Table of Contents
FOREWORD ................................................................................................................................ iv
PART 1 – GENERAL .................................................................................................................... 1
1.1 Purpose .......................................................................................................................... 1
1.2 Management, Authority, and Responsibility for 3-A SSI Standards and 3-A Accepted
Practices Activities ......................................................................................................... 1
PART 2 – PROCEDURES FOR THE DEVELOPMENT OF 3-A SANITARY STANDARDS AND
3-A ACCEPTED PRACTICES ............................................................................................... 2
2.1 3-A Sanitary Standards and 3-A Accepted Practices Interest Categories ..................... 2
2.2 Secretariat ...................................................................................................................... 2
2.3 3-A Steering Committee ................................................................................................. 2
2.3.1 3-A Steering Committee Chair ..................................................................................... 3
2.3.2 3-A Steering Committee Responsibilities ..................................................................... 3
2.3.3 Criteria for Consideration of 3-A Sanitary Standards and 3-A Accepted Practices ..... 4
2.3.4 Actions Requiring Approval by a Majority of the 3-A Steering Committee ................... 4
2.4 3-A Work Groups............................................................................................................ 5
2.4.1 3-A Work Group Chair .................................................................................................. 5
2.4.2 3-A Work Group Responsibilities ................................................................................. 5
2.4.3 3-A Work Group Majority Requirements ...................................................................... 6
2.4.4 3-A Work Group Observers .......................................................................................... 6
2.5 Consensus and Due Process Policies ........................................................................... 6
2.5.1 Steering Committee ...................................................................................................... 7
2.5.2 Coordination and Harmonization .................................................................................. 7
2.5.3 Notification of Standards Development or Activity ....................................................... 8
2.5.4 Voting Procedures and Policies ................................................................................... 8
2.6 Substantive Changes ................................................................................................... 10
2.7 Report of Final Result .................................................................................................. 10
2.8 Submittal of Standard ................................................................................................... 10
2.9 Effective Date of Standards ......................................................................................... 10
2.10 Meetings ....................................................................................................................... 10
2.10.1 Open Meetings ......................................................................................................... 11
2.11 Appeals ........................................................................................................................ 11
2.11.1 Notice of Appeal ........................................................................................................ 11
2.11.2 Response to an Appeal ............................................................................................. 11
2.11.3 Appeals Panel and the Hearing ................................................................................ 11
2.11.4 Conduct of the Hearing ............................................................................................. 11
2.11.5 Decision ..................................................................................................................... 12
2.12 Interpretations Policy .................................................................................................... 12
2.13 Commercial Terms and Conditions .............................................................................. 13

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Procedures for the Development and Maintenance of 3-A SSI Standards and 3-A Accepted Practices

2.14 Metric Policy ................................................................................................................. 13


2.15 Patent Policy ................................................................................................................ 13
2.16 Records Retention Policy ............................................................................................. 14
2.17 Revisions of Rules, Policies, and Procedures ............................................................. 14
2.18 Maintenance of 3-A Standards..................................................................................... 15
2.19 Procedures for the Development of a Provisional 3-A Sanitary Standard, Accepted .. 15
Practice, or a Provisional Amendment to a 3-A Sanitary Standard or Accepted Practice
Appendix A ....................................................................................................................... .......... 17
Appendix B ....................................................................................................................... .......... 19
Appendix C ...................................................................................................................... .......... 20
Appendix D ...................................................................................................................... .......... 22

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Procedures for the Development and Maintenance of 3-A SSI Standards and 3-A Accepted Practices

FOREWORD

3-A Sanitary Standards, Inc. (3-A SSI) is a not-for-profit 501(c)(3) organization whose mission is to
enhance product safety for consumers of food, beverages, pharmaceutical products, and other
comestibles through the development and use of standards and accepted practices, known
collectively as 3-A SSI Standards and 3-A Accepted Practices. The standards and accepted
practices developed for food, beverage, and dairy processing equipment are known as 3-A
Sanitary Standards and 3-A Accepted Practices. The standards for pharmaceutical manufacturing
equipment are known as P3-A Standards.

Background

The history of 3-A Sanitary Standards and 3-A Accepted Practices extends back to the 1920s when
the entities representing equipment fabricators, users/processors and sanitarians formulated the
first uniform standards for fittings used on milk pipelines. The standards became known as the 3-A
Sanitary Standards in recognition of the three stakeholder groups.

3-A SSI was officially incorporated in August 2002 by the organizations now representing these
stakeholder groups, also known as the Founding Member Organizations. These Founding Member
Organizations include the 3-A Sanitary Standards Symbol Administrative Council (Council);
American Dairy Products Institute (ADPI); International Association for Food Protection (IAFP);
Food Processors Suppliers Association (FPSA); and the International Dairy Foods Association
(IDFA). Two representatives of each Founding Member Organization serve as voting members on
the 3-A SSI Board of Directors. The 3-A SSI Board of Directors includes three non-voting Directors
consisting of one member of the 3-A Steering Committee and one representative each of the Food
and Drug Administration/Public Health Service (FDA/PHS) and the U.S. Department of Agriculture
(USDA).

With the formation of 3-A SSI, the three interest groups became organized in a single, independent
entity. The structure of 3-A SSI was designed to balance the three interest groups in the
leadership and in the day-to-day management of standards development. A new 3-A Steering
Committee, balanced by interest group, was designated to manage the 3-A Sanitary Standards
development program.

These procedures are designed to comply with the American National Standards Institute ANSI
Essential Requirements: Due Process Requirements for American National Standards. The
purpose of the document is twofold: 1) provide a concise overview of the role and the function of
the 3-A Steering Committee as they operate within the ANSI voluntary consensus system; and 2)
provide the 3-A Steering Committee with a procedure manual for developing American National
Standards, according to rules that 3-A SSI must observe in order to operate as an ANSI-accredited
Standards Developing Organization.

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Procedures for the Development and Maintenance of 3-A SSI Standards and 3-A Accepted Practices

PART 1 - GENERAL

1.1 Purpose

3-A Sanitary Standards (for equipment) or 3-A Accepted Practices (for systems) establish criteria
for equipment, materials, hygienic design, and fabrication to assure the cleanability of equipment
used for dairy, food, pharmaceutical, or other comestible processing, packaging and handling. 3-A
Accepted Practices may include installation, control and regulatory criteria. Equipment performance
and operator safety are not included.

The procedures shall govern the activities of 3-A SSI related to the development, approval,
revision, reaffirmation or withdrawal of 3-A Sanitary Standards and 3-A Accepted Practices for the
sanitary design, fabrication and installation of equipment and machinery for dairy, food or other
comestibles.

A Glossary of Key Terms used in these Procedures is shown in Appendix C.

1.2 Management, Authority, and Responsibility for 3-A SSI Standards and 3-A Accepted
Practices Activities

Overall management of 3-A SSI is vested in the Board of Directors. The 3-A Steering Committee
shall report and be responsible to the Board of Directors of 3-A SSI. Management, authority, and
responsibility for the 3-A Sanitary Standards and 3-A Accepted Practices activities rests with the 3-
A Steering Committee and its appointed Work Groups (WGs).

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Procedures for the Development and Maintenance of 3-A SSI Standards and 3-A Accepted Practices

PART 2 – PROCEDURES FOR THE DEVELOPMENT OF 3-A SANITARY STANDARDS


AND 3-A ACCEPTED PRACTICES

2.1 3-A Sanitary Standards and 3-A Accepted Practices Interest Groups

The 3-A Sanitary Standards and 3-A Accepted Practices development activity encompasses three
cooperating interest groups.

a) Equipment Fabricators - The Equipment Fabricators Group represents those persons,


companies or trade associations and their consultants who are original equipment
manufacturers (OEMs), fabricators, distributors or installers of equipment covered by 3-A
Sanitary Standards and/or 3-A Accepted Practices.
b) Processors/Users - The Processors/Users Group represents those persons, companies or
trade associations and their consultants who are users of dairy, and/or food processing
equipment or systems covered by 3-A Sanitary Standards and/or 3-A Accepted Practices.
c) Public Interest – The Public Interest Group represents state and local milk regulatory
officials (Sanitarians), representative(s) from academia, the USDA Dairy Programs, the
FDA and other sanitarians, consumers and others.

All interest group members should possess a general knowledge of sanitary principles, and
knowledge of equipment and systems used to process, package, and handle dairy products and
other comestibles.

2.2 Secretariat

3-A SSI (herein designated as “Secretariat”) shall be responsible for maintaining the duties of the
Secretariat for all WGs and ad hoc groups established in accordance with these procedures:

a) Organize the WGs and ad hoc groups in consultation with the 3-A Steering Committee.
b) Oversee compliance with these procedures.
c) Maintain rosters of all committees, WGs, and ad hoc groups and a list of standards or other
documents for which it is responsible.
d) Provide administrative support for the 3-A Steering Committee, WGs and ad hoc groups,
including secretarial services; arrange meetings; prepare and distribute meeting agendas,
minutes, ballots and draft standards; and maintain adequate records.
e) Submit proposed standards and revisions thereto approved by the WG or 3-A Steering
Committee for public review, and approval.
f) Publish approved 3-A Sanitary Standards or 3-A Accepted Practices and approved
revisions and addenda.
g) Perform other administrative functions as required by these procedures, including oversight
of compliance with these procedures, the administration of appeals and interpretations.

2.3 3-A Steering Committee

In accordance with the Bylaws of 3-A SSI, the Board of Directors of 3-A SSI shall designate the
voting membership of the 3-A Steering Committee.

The standards development process should have a balance of interests. Participants from diverse
interest categories shall be sought with the objective of achieving balance. If a consensus body
lacks balance in accordance with the historical criteria for balance, outreach to achieve balance
shall be undertaken.

The standards development process shall not be dominated by any single interest category,
individual or organization. Dominance means a position or exercise of dominant authority,
leadership, or influence by reason of superior leverage, strength, or representation to the exclusion

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Procedures for the Development and Maintenance of 3-A SSI Standards and 3-A Accepted Practices

of fair and equitable consideration of other viewpoints.

The Committee may appoint non-voting members at its discretion. Non-voting members shall
include: 1) representatives of regional, national, or international organizations materially affected by
3-A Sanitary Standards and/or 3-A Accepted Practices, 2) interested parties willing to share
information or to harmonize standards, or 3) individuals who can perform a function deemed
important to the completion of the 3-A Steering Committee’s goals.

There shall be a 3-A Steering Committee that shall establish standard operating procedures and
shall oversee and prioritize 3-A Sanitary Standards and 3-A Accepted Practices development.
Except as described below, the Committee shall have eighteen (18) voting members, six appointed
by FPSA, six appointed by IDFA, and two each appointed by IAFP, FDA/PHS, and USDA. The
Committee may appoint non-voting members at its discretion. No voting member of the 3-A
Steering Committee may serve concurrently on the Corporation Board of Directors as a voting
member. The 3-A Steering Committee shall report and be responsible to the Board of Directors of
the Corporation. The Board of Directors shall appoint a Chair of the Committee, either from among
the Committee members or as a nineteenth, non-voting member. Other Committee officers may be
elected by a majority vote of the voting members of the Committee.

2.3.1 3-A Steering Committee Chair

The Board of Directors of 3-A SSI shall appoint a Chair of the Committee, either from among the
committee members or as an additional voting member.

The Chair shall:

a) Assure that meeting agendas have been prepared by the Secretariat with adequate input
from committee members, and other interested parties.
b) Oversee the distribution of agendas by the Secretariat in a timely fashion that will permit
proper consideration of issues by committee members.
c) Attend and preside at 3-A Steering Committee meetings.
d) Conduct meetings in accordance with all due process requirements. On questions of
parliamentary procedures not covered in these procedures, Robert’s Rules of Order (latest
edition) should be followed to expedite due process.
e) Present policy issues to the 3-A SSI Board of Directors for consideration and action.
f) Recommend to the 3-A SSI Board of Directors the replacement of nonparticipating voting
members.
g) Evaluate requests for new 3-A Sanitary Standards or 3-A Accepted Practices activity for
relevance to the mission and goals of 3-A SSI and assign the task to the appropriate WG in
conjunction with the appropriate Work Group Chair Officers.
h) The Chair shall serve no more than two consecutive terms of three years.

The voting members shall elect a Vice Chair from the voting members to assist the Chair and to
assume the duties of the Chair in the absence of the Chair. The term for the Vice Chair shall
correspond to the term of office for the 3-A Steering Committee Chair.

2.3.2 3-A Steering Committee Responsibilities

While the outcome is not binding, unless binding provisions are agreed to by the developer,
participants are encouraged to develop a consensus on whether and how the standards
development project should proceed.

The 3-A Steering Committee shall:

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Procedures for the Development and Maintenance of 3-A SSI Standards and 3-A Accepted Practices

a) Determine policies and procedures for the committee and WGs consistent with the general
requirements of these Procedures.
b) Administer these policies and procedures for the committee and WGs.
c) Oversee the current inventory of 3-A Sanitary Standards and 3-A Accepted Practices and
recommend actions to assure that documents are presented for revision, reaffirmation or
withdrawal every five (5) years.
d) Evaluate requests for new 3-A Sanitary Standards or 3-A Accepted Practices activity for
relevance to the mission and goals of 3-A SSI and assign the task to the appropriate WG.
e) Assign priorities for proposed new 3-A Sanitary Standards or 3-A Accepted Practices
activity and, if necessary, to those in progress.
f) Maintain liaison with other national and international standards development organizations
and other bodies as necessary on matters of relevance to 3-A Sanitary Standards and 3-A
Accepted Practices.

Voting members of the Steering Committee shall:

a) Advise and provide the Chair and the Secretariat with appropriate information pertaining to
the general application of 3-A Sanitary Standards and 3-A Accepted Practices in relation to
industry and regulatory requirements.
b) Participate on a regular basis in committee meetings. If a member is unable to attend
these meetings, a written explanation to the Chair may be required.
c) Respond to all correspondence requiring a reply by the closing date.
d) Submit ballots by the identified closing date.

2.3.3 Criteria for the Consideration of 3-A Sanitary Standards and 3-A Accepted Practices

The 3-A Steering Committee shall employ the following criteria when evaluating the need for new,
revised or amended 3-A Sanitary Standards or 3-A Accepted Practices.

a) 3-A SSI, through its consensus document development activities, supports the
compatibility of provisions of 3-A Sanitary Standards and 3-A Accepted Practices with
federal, state and local regulations.
b) Only equipment, materials, and fabrications processes that are available on the
commercial market are eligible for consideration for new, revised or amended 3-A Sanitary
Standards or 3-A Accepted Practices.
c) Demonstrated need (by Applicant) for the requested standard amendment or revision.
d) Scheduled 5-year up-dates.

2.3.4 Actions Requiring Approval by a Majority of the 3-A Steering Committee

The following actions require approval by a majority of the voting membership of the Committee
whether at a meeting, letter, or e-mail ballot:

a) Adoption of committee operating procedures, interest category, or revisions thereof.


b) Approval of minutes.
c) Approval to initiate work on a new, or revisions to an existing 3-A Sanitary Standard or 3-A
Accepted Practice, or withdrawal of an existing 3-A Sanitary Standard or 3-A Accepted
Practice.
d) Formation (and later disbandment) of WGs.

Following approval by the 3-A Steering Committee, actions shall follow the Protocol for Document
Development shown in Appendix A.

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Procedures for the Development and Maintenance of 3-A SSI Standards and 3-A Accepted Practices

2.4 3-A Work Groups

The 3-A Steering Committee may designate WGs to expedite work of the Steering Committee.
The formation (and later disbandment) of a WG requires approval by a majority vote of the 3-A
Steering Committee. A list of current WGs is maintained on the 3-A SSI web site. The scope and
duties delegated to the WG shall be approved at the time it is formed, and subsequent changes in
scope or duties shall also require approval by the 3-A Steering Committee. The charge to the WG
shall clearly state whether the WG is responsible for developing the definitive content of one or
more standards and for responding to views and objections thereon.

WG members are designated by the 3-A Steering Committee from the three 3-A SSI interest
categories. The 3-A Steering Committee shall maintain membership of at least two representatives
from each interest category in each WG. The WG must notify the 3-A Steering Committee and the
Secretariat of any changes in membership.

The WG Chair makes nominations for appointments and discharges to the WG with
recommendation of the Secretariat and approval by the 3-A Steering Committee. In addition to
interest category affiliation, the 3-A Steering Committee may apply specific criteria in the
designation of members of a WG, such as whether a candidate is knowledgeable of the specific
equipment, systems or materials covered by the 3-A document(s) assigned to the WG. They may
be, but are not limited to, original equipment manufacturers (OEMs), suppliers to OEMs,
consultants of record to OEMs or consumers.

The number of members of a specified WG is not limited. Each member is considered as a voting
member. There shall be only one (1) voting member per entity (i.e., company or company division,
federal or state agency, or university) on a WG. The determination of a company or company
division for the purpose of participation on a WG shall be made by the WG Chair and based upon
the type of equipment manufactured, used, or inspected. For example, a company that
manufactures plate heat exchangers, tubular heat exchangers, and ice cream freezers may have a
voting member from each entity on the respective WG provided the equipment is manufactured by
separate company divisions; similarly, a processing company that produces fluid milk and dry milk
at separate operations may have a voting member from each entity.

The 3-A Steering Committee Chair shall review the scope, duties, and membership of all WGs
annually. The 3-A Secretariat shall maintain for each WG a membership roster that includes the
following information:

a) Title of the WG and its designation;


b) Scope of the WG;
c) Chair and Vice Chair;
d) Name of members, addresses, and business affiliations, e-mail, phone, fax, etc.;
e) Interest category (i.e., Fabricator, User, Sanitarian);

2.4.1 3-A Work Group Chair

The WG shall elect a Chair and Vice Chair from their members. There is no fixed term for either of
these positions. A vote for a Chair or Vice Chair will be called by the Secretariat whenever either
position resigns or a request for a vote has been received from at least three (3) group members.

The WG Chair is responsible for:

a) Preparing agendas and planning for meetings necessary to carry out the function of the
WG.
b) Directing the formulation and development of the documents assigned to the WG.
c) In consultation with the Secretariat, preparing draft documents of the WG for balloting.
d) Maintaining appropriate administrative records relating to the actions of the WG.

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Procedures for the Development and Maintenance of 3-A SSI Standards and 3-A Accepted Practices

e) Regular participation in WG meetings and other 3-A SSI meetings/functions as is deemed


necessary to conduct the business of the WG.
f) Reviewing and resolution of comments and negative ballots pertaining to WG documents.
g) Selection of a WG member to act as the Liaison and Technical Advisor for Interpretations
Group (IG) deliberations, when needed.

2.4.2 3-A Work Group Responsibilities

As assigned by the 3-A Steering Committee, the WG is responsible for drafting:

a) All or a portion of a 3-A Sanitary Standard or 3-A Accepted Practice,


b) Responses to comments,
c) Comments on international standards, or
d) Other ballot functions as directed by the 3-A Steering Committee.

The WG is also responsible for providing a liaison and technical advisor to the Interpretations
Group (IG) for matters of 3-A Sanitary Standard or 3-A Accepted Practice interpretation, when
requested.

WG members shall:

a) Participate on a regular basis in WG meetings.


b) Actively participate in the routine functions of the WG, such as soliciting comments and
seeking reconciliation of viewpoints on any tentative document.
c) Answer all correspondence requiring a reply and ballots by the closing date.

A WG member may be removed from the WG for:


a) Two successive unexcused absences from WG meetings,
b) Failure to respond to two consecutive WG ballots, or
c) Failure to respond to correspondence from the Chair of the WG.

Written notice to the committee member of this action will be provided by the Secretariat.

2.4.3 3-A Work Group Majority Requirements

A ballot of the members of the WG shall be taken in accordance with Sections 2.5.4.2 and 2.5.4.3
for the approval of a draft 3-A Sanitary Standard or 3-A Accepted Practice or any substantive
change in the content of a 3-A Sanitary Standard or 3-A Accepted Practice to be presented to the
Steering Committee for final approval. For a WG ballot to be “official” and valid, a return by at least
50% of voting members is required in each Interest category. Should any interest category have
more than 50% of their submitted ballots voting “Negative (with reasons)”, the document shall not
advance to the Steering Committee until the outstanding issues are resolved.

2.4.4 3-A Work Group Observers

Anyone interested in participating in the activities of any WG will be, at a minimum, assigned
observer membership. Observer members are invited to actively participate in all WG activities
and are encouraged to comment on all documents. Observer members shall not have a vote but
the WG must consider their comments.

2.5 Consensus and Due Process Policies

“Consensus” means directly and materially affected interest categories have reached substantial
agreement. This signifies the concurrence of more than a simple majority, but not necessarily
unanimity. Consensus requires that all views and objections be considered, and that an effort be
made toward their resolution.

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Procedures for the Development and Maintenance of 3-A SSI Standards and 3-A Accepted Practices

2.5.1 Steering Committee

The Steering Committee shall consist of the voting members of the 3-A Steering Committee and
other interested parties approved by the 3-A SSI Board of Directors, and must also be in one of the
interest categories defined in Section 2.1 of these procedures. The Steering Committee shall be
sufficiently diverse to ensure reasonable balance without dominance by a single interest category
in accordance with ANSI Essential Requirements: Due Process Requirements for American
National Standards. If the Steering Committee lacks balance in accordance with ANSI’s historical
criteria for balance outreach to achieve balance shall be undertaken.

The affiliation and interest category of each member of the Steering Committee shall be made
available to interested parties upon request. If the Steering Committee member is serving in an
individual capacity, then the name of the individual, that person’s employer and interest category
should be available. In such case, employer contact information is not required.

Voting by the Steering Committee occurs after the document has been developed by the assigned
WG and has been subject to appropriate public notice(s) with resolution of any comments or
concerns raised through the public notice(s).

The Steering Committee shall be responsible for:

a) Voting on approval of proposed 3-A Sanitary Standards and 3-A Accepted Practices within
the scope of the 3-A Steering Committee;

b) Maintaining the standards developed by 3-A SSI designated as American National


Standards in accordance with ANSI Essential Requirements: Due Process Requirements
for American National Standards.

Steering Committee members who do not return two consecutive ballots shall be contacted to
confirm their continuing interest. A non-response to this contact after (30) days will be considered
a lack of interest and the non-responsive member will be removed from the Steering Committee. A
removed Steering Committee member may reapply for participation on the Steering Committee.

2.5.2 Coordination and Harmonization

Good faith efforts shall be made to resolve potential conflicts between and among existing
American National Standards and candidate American National Standards.

2.5.2.1 Definition of Conflict

Conflict within the ANS process refers to a situation where, viewed from the perspective of a future
implementer, the terms of one standard are inconsistent or incompatible with the terms of the other
standard such that implementation of one standard under terms allowable under that standard
would preclude proper implementation of the other standard in accordance with its terms.

2.5.2.2 Coordination/Harmonization

3-A SSI will make a good-faith effort to resolve potential conflicts and to coordinate standardization
activities intended to result in harmonized American National Standards. A “good faith” effort will
require substantial, thorough and comprehensive efforts to harmonize a candidate ANS and
existing ANSs. Such efforts will include, at minimum, compliance with all relevant sections of these
procedures. 3-A SSI will retain evidence of such efforts in order to demonstrate compliance with
this requirement to the satisfaction of the appropriate ANSI body.

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Procedures for the Development and Maintenance of 3-A SSI Standards and 3-A Accepted Practices

2.5.3 Notification of Standards Development or Activity

2.5.3.1 3-A Sanitary Standards and Accepted Practices

Proposals for new 3-A Sanitary Standards or 3-A Accepted Practices or reaffirmation, revision or
withdrawal of existing 3-A Sanitary Standards or 3-A Accepted Practices shall be announced to the
Founding Member Organizations of 3-A SSI (ADPI, IAFP, FPSA, and IDFA), FDA Milk Safety
Branch, USDA Dairy Programs, industry trade press, and other interested parties to give the
opportunity for participation by all directly and materially affected persons.

2.5.3.2 American National Standards

For candidate American National Standards refer to the Operating Procedures for the Development
of American National Standards by 3-A Sanitary Standards, Inc. (3-A SSI).

2.5.4 Voting Procedures and Policies

2.5.4.1 Ballots

New 3-A Sanitary Standards or 3-A Accepted Practices, reaffirmation and revision of existing 3-A
Sanitary Standards or 3-A Accepted Practices, and the withdrawal of 3-A Sanitary Standards or 3-
A Accepted Practices shall be approved by electronic ballot of the Steering Committee. This
includes e-mail and facsimile.

Administrative and editorial changes to 3-A Sanitary Standards and 3-A Accepted Practices that
are non-substantive may be decided by a majority of the members present at a regularly scheduled
meeting of the 3-A Steering Committee.

2.5.4.2 Voting

The ballot notification shall include:

a) The purpose and intended application of the 3-A Sanitary Standard or 3-A Accepted
Practice;
b) A brief history and explanation of how the document was developed;
c) A copy of the complete proposed 3-A Sanitary Standard or 3-A Accepted Practice or the
relevant portion under consideration when the Steering Committee member has previously
received the complete standard;
d) Official ballot(s) to all voting body members.

Each member of the voting body shall vote one (1) of the following positions:

Affirm;
Affirm, with comment;
Negative, with reasons; or
Abstain, with reasons (for example, “no interest”).

A negative ballot, to be accepted, shall be accompanied by any comments that are related to the
proposal under consideration and should include specific wording or actions that would resolve the
objection.

The member submitting the ballot and the date of ballot submission shall be verified. A typed
name on an electronic ballot shall be considered as a signature. Voting by alternates or proxies is
not permitted. A sample ballot is shown in Appendix B.

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Procedures for the Development and Maintenance of 3-A SSI Standards and 3-A Accepted Practices

2.5.4.3 Voting Period

The voting period for ballots shall end no less than (30) days from the date of issue or as soon as
all ballots are returned, whichever comes earlier. An extension may be granted at the Secretariat’s
option, when warranted.

A follow-up notification requesting immediate return of the ballot shall be sent to members whose
votes have not been received within (10) calendar days before the ballot closes.

Within thirty (30) days after the close of an electronic ballot, the Secretariat shall report the results,
including all comments, to the Chair and Document Leader(s). All ballots with reasons shall be
resolved in accordance with Section 2.5.4.6.

2.5.4.4 Majority Requirements for Actions by the Steering Committee

The following actions require a ballot with a total return by at least 80% of the Steering Committee.
Approval requires an affirmative vote by a minimum of 70% of the entire Steering Committee.

Approval of a new 3-A Sanitary Standard or 3-A Accepted Practice, withdrawal of an


existing 3-A Sanitary Standard or 3-A Accepted Practice, or reaffirmation of an existing
document.
Approval of revision or addendum to part or all of a 3-A Sanitary Standard or 3-A Accepted
Practice.
Approval of a negative vote being found persuasive.
Approval for submission to ANSI of a change in scope.

2.5.4.5 Reporting Votes

The results of each vote on all 3-A Sanitary Standard or 3-A Accepted Practice shall be reported as
follows:

Number of members.
Number of members voting affirmatively.
Number of members voting negatively with reasons.
Number of members voting negatively without reasons.
Number of members abstaining.
Number of members not returning ballots.
Listing of comments submitted.

2.5.4.6 Resolution of Comments

When the balloting or Public Notice comment period has been closed, the Secretariat shall forward
the ballot tally and all comments to the Document Leader(s), Chair of the 3-A Steering Committee
and the Chair of the WG. Prompt consideration shall be given to the written views and objections
of all voters, including written comments from public review. An effort to resolve all written
objections shall be made, and each objector shall be advised in writing of the disposition of the
objection and the reasons thereof.

Objections that are not accompanied by reasons shall be recorded as “negative without reasons”
and no further resolution shall be required. Objections given with reasons shall be referred by the
Secretariat to the Chair of the WG and Document Leader(s) responsible for the document in
question. The WG Chair and Document Leader(s) shall classify each ballot or Public Notice
comment as substantive or non-substantive and seek consensus through a resolution of
comments. If it is determined that substantive changes are required, specific language for the
revision shall be prepared and approved by the WG. Only the revised provision(s) shall be re-
balloted by the Steering Committee and submitted for public review if a candidate ANS document.
If an item has had prior discussion, i.e. substantially the same comment(s) is repeated that was

9
Procedures for the Development and Maintenance of 3-A SSI Standards and 3-A Accepted Practices

previously made on the same issue within the same revision cycle of a particular document, it shall
not be necessary to reconsider it unless new information has been introduced.

All unresolved negative votes with comment from the Steering Committee and all unresolved
objections from public review along with attempts at resolution shall be reported to the Steering
Committee in order to afford all members of the Steering Committee an opportunity to respond,
reaffirm, or change their vote. The recirculation of all unresolved objections shall be in accordance
with Section 2.5.4.4. If after the recirculation ballot, any unresolved objectors remain unresolved,
he or she shall be informed in writing of his or her right to appeal procedural action or inaction and
that an appeals process exists within the procedures used by 3-A SSI. The appeals process is
outlined in Section 2.12.

All unresolved objectors from public review shall be informed in writing of their right to appeal
procedural action or inaction and that an appeals process exists within the procedures used by 3-A
SSI.

The WG Chair and Document Leader(s) shall prepare a statement giving the rationale for their
resolution on each comment with the names of individuals and organizations involved in the
determination.

2.6 Substantive Changes

Proposed substantive change(s) require an additional 30-day ballot for the Working Group and for
the Steering Committee. Only the substantive changes, not the entire draft, are subject to these
follow-up requirements. A substantive change in a proposed 3-A Sanitary Standard or 3-A
Accepted Practice is one that directly and materially affects the use of the 3-A Sanitary Standard or
3-A Accepted Practice. Examples of substantive changes are below:

a) “Shall” to “should” or “should” to “shall”;


b) Addition, deletion or revision of requirements, regardless of the number of changes;
c) Addition of mandatory compliance with referenced standards.

2.7 Report of Final Result

The Secretariat shall report the final result of the voting, by interest categories, to the 3-A SSI
Board of Directors, the 3-A Steering Committee, WG and other entities as determined by the 3-A
SSI Board of Directors.

2.8 Submittal of Standard

If the 3-A Sanitary Standard or 3-A Accepted Practice is a candidate American National Standard,
upon completion of the procedures for voting, resolution of comments, and appeals, the proposed
3-A Sanitary Standard or 3-A Accepted Practice shall be submitted to ANSI by the Secretariat for
ANSI final approval.

Refer to the American National Standards Operating Procedures for 3-A Sanitary Standards, Inc.
(3-A SSI) for more information on the requirements for submittal of a candidate (ANS) American
National Standard.

2.9 Effective Date of Standards

The effective date for 3-A Sanitary Standards and 3-A Accepted Practices shall be (45) days
following approval by the Steering Committee.

2.10 Meetings

Meetings of the 3-A Steering Committee or a WG shall be held at the request of the respective

10
Procedures for the Development and Maintenance of 3-A SSI Standards and 3-A Accepted Practices

Chairs or Secretariat or by petition of one-third or more of Committee members. Where used in


this document, meeting refers to in-person, on-line or phone conference.

2.10.1 Open Meetings

Meetings of the WG shall be open to all members and others having an interest. At least (15) days
notice of meetings shall be given by the Secretariat. Meetings that require travel shall require at
least (60) days notice. An agenda shall be prepared and distributed with the meeting notice.

Observers shall not have the right to vote. Observers shall be entitled to receive copies of meeting
reports if requested in writing.

2.11 Appeals

Persons who have directly and materially affected interests and who have been or may be
adversely affected by a procedural action or inaction of the Steering Committee or the Secretariat
have the right to appeal. Informal appeals to 3-A SSI staff are available and should be attempted
first by contacting staff and requesting as such. Staff will discuss the matter among the parties and
attempt to reach a mutually agreeable resolution. If the informal appeal is unsuccessful, the formal
appeals process that follows may be pursued.

2.11.1 Notice of Appeal

Notice of intention to appeal a procedural issue must be filed by certified mail with the Secretariat
within (30) days after the date of notification of right to appeal or at any time with respect to
inaction. The complaint shall state the nature of the objection(s) including any adverse effects, the
section(s) of these Procedures or the specific actions or inactions that are at issue, and the specific
remedial action(s) that would satisfy the appellant’s concerns. Previous efforts to resolve the
objection(s) and the outcome of each shall be noted.

2.11.2 Response to an Appeal

Within (30) days after the receipt of the complaint, the Secretariat shall respond in writing to the
appellant, specifically addressing each allegation in the complaint to the extent possible. The
Secretariat shall attempt to resolve the complaint informally.

If the appellant and the Secretariat are unable to resolve the written complaint informally in a
manner consistent with these Procedures, the Secretariat shall schedule a hearing with the
appropriate appeals panel on a date agreeable to all participants, and providing at least (10)
calendar days notice.

2.11.3 Appeals Panel and the Hearing

The 3-A Steering Committee shall appoint a three-person appeals panel. The appeals panel shall
consist of three individuals who have not been directly involved in the dispute and who will not be
materially affected by any decision made in the dispute. The panel will consist of one
representative of each interest category selected from members of the 3-A SSI Board of Directors.
Two of the appointees must be acceptable to the appellant. Two of the appointees must be
acceptable to the 3-A Steering Committee. The appeals panel will act only on questions of
conformance to Procedures.

2.11.4 Conduct of the Hearing

Within (15) days of the inability to resolve the matter informally, the Appeals Panel shall meet with
the appellant and Secretariat. The appellant has the responsibility of demonstrating improper
actions or inaction, the adverse effects there from and the efficacy of the requested remedial
action. The Secretariat has the responsibility of demonstrating that the Steering Committee and

11
Procedures for the Development and Maintenance of 3-A SSI Standards and 3-A Accepted Practices

the Secretariat took all actions in question in compliance with these Procedures and that the
requested remedial action would be ineffective or detrimental.

2.11.5 Decision

The appeals panel shall render its decision in writing within (30) days, stating its findings of fact and
conclusions, with reasons therefore and citing the evidence. The Secretariat shall notify the
appellant and the 3-A Steering Committee of the decision of the appeals panel, which shall be
binding and final on all concerned.

2.12 Interpretations Policy

2.12.1 Submission of Requests

Requests for interpretations of 3-A Sanitary Standards or 3-A Accepted Practices shall be
submitted in writing to the Secretariat using the Request for the Interpretation of 3-A Sanitary
Standards and 3-A Accepted Practices Criteria Form. The request form is available on line at
http://www.3-a.org/Standards-Committees/Interpretations-and-Public-Review-Drafts or
upon request from the Secretariat.

The Secretariat shall encourage requesters to avoid open-ended questions and pose their
interpretation question in a form such that it can be answered with a “yes” or “no” response (for
example: "Does the standard allow for ..." as opposed to "Explain the meaning of ...").

The Secretariat shall promptly acknowledge receipt of the request to the requester with written
information on the actions that will be taken.

The Secretariat may directly respond to a request for interpretation only if the question posed can
be answered by making a direct citation to the 3-A Sanitary Standard or 3-A Accepted Practice.
The Chair of the 3-A Steering Committee must concur in the response of the Secretariat.

2.12.2 Appointment of Interpretations Group

Requests that cannot be resolved by the Secretariat in accordance to 2.13.1 shall be forwarded by
the Secretariat to a review body called the Interpretations Group (IG). Formation of the IG shall be
coordinated by the Secretariat and shall consist of five voting members appointed in the following
manner.

The USDA representative to the 3-A SSI Board of Directors shall designate one voting member.

The FDA representative to the 3-A SSI Board of Directors shall designate one voting member.

The voting members of the Board of Directors from the three interest groups (Equipment
Fabricators, Processors/Users, and Public Interest) shall designate one voting representative of
each 3-A SSI Interest Group from the membership of the Work Group which is responsible for
oversight of the document for which the interpretation has been requested, or other subject matter
expert.

The Chair of the 3-A Steering Committee may designate other subject matter experts to join the IG
as non-voting participants in the review of a request for interpretation,

The Chair of the 3-A Steering Committee shall act as Chair of the IG. The Chair shall convene the
IG, including non-voting members and the Secretariat, to conduct a review of the request for
interpretation within 30 days from the date of receipt of the request by the Secretariat.

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Procedures for the Development and Maintenance of 3-A SSI Standards and 3-A Accepted Practices

2.12.3 Review and Voting

An interpretation by the IG shall be limited to providing clarification and explanation of the existing
Standard or Practice. Interpretations should not give rise to lengthy explanations that may
inadvertently modify or amend the Standard or Practice. If an interpretation is due to faulty or
unclearly written criteria, the IG shall recommend to the 3-A Steering Committee that conflicting
issues should be resolved by amendment or revision to the 3-A Sanitary Standard(s) or 3-A
Accepted Practice(s). The IG may also recommend how such issues should be handled until the
3-A Sanitary Standard(s) or 3-A Accepted Practices(s) is amended or revised.

A 2/3 affirmative vote of IG voting members via conference call, meeting, or electronic letter ballot
is required for passage of an official interpretation.

If a final decision cannot be concluded within a period of 30 days, the Secretariat shall notify the
requester that the request is being processed, the reason(s) for the delay; and an estimate of when
a decision will be issued.

A summary of each IG decision, including the citation of any regulations or references that
supported the decision, shall be published on the 3-A SSI web site to foster uniform interpretation
of the criteria. The Secretariat shall make notification of the decision to all 3-A SSI stakeholder
groups, including the 3-A SSI Board of Directors.

2.13 Commercial Terms and Conditions

3-A SSI will comply with the most current version of ANSI’s Commercial Terms and Conditions
Policy. This policy states that guarantees, warranties, and other commercial terms and conditions
will not be included in an American National Standard. The appearance that a 3-A Standard
endorses any particular products, services or companies will be avoided. If a sole source exists for
essential equipment, materials or services necessary to comply with or to determine compliance
with a 3-A Standard, a footnote or informative annex will be included that provides the name and
address of the source, and will also state that “equivalent” equipment, materials or services may be
used.

2.14 Metric Policy

3-A Sanitary Standards and 3-A Accepted Practices shall be written in dual Metric and U.S.
customary units as follows. All consensus documents will be published in dual units in a single
document. All values will be rounded to acceptable values in both U.S. and Metric units, and not
necessarily mathematical equivalents. All U.S. and Metric values are to be agreed by the
appropriate WG.

2.15 Patent Policy

A proposed 3-A SSI American National Standard may include the use of an essential patented
claim (one whose use would be a requirement for compliance with that standard), if it is considered
that technical reasons justify this approach. Participants in the 3-A/ANSI standards development
process are encouraged to bring patents with claims believed to be essential to the attention of 3-A
SSI. If 3-A SSI receives a notice that a proposed, revised, or approved 3-A American National
Standard may require the use of such a patent claim that is not already covered by an existing
assurance, the procedures in this clause shall be followed.

Such assurance shall indicate that the patent holder (or third party authorized to make assurances
on its behalf) will include in any documents transferring ownership of patents subject to the
assurance, provisions sufficient to ensure that the commitments in the assurance are binding on
the transferee, and that the transferee will similarly include appropriate provisions in the event of
future transfers with the goal of binding each successor-in-interest. The assurance shall also

13
Procedures for the Development and Maintenance of 3-A SSI Standards and 3-A Accepted Practices

indicate that it is intended to be binding on successors-in-interest regardless of whether such


provisions are included in the relevant transfer documents.”

3-A SSI shall receive from the patent holder or party authorized to make assurances on its behalf,
in written or electronic form, either:

a) assurance in the form of a general disclaimer to the effect that such party does not
hold and does not currently intend holding any essential patent claim(s); or
b) assurance that a license to such essential patent claim(s) will be made available to
applicants desiring to utilize the license for the purpose of implementing the standard
either:

i) under reasonable terms and conditions that are demonstrably free of any unfair
discrimination; or
ii) without compensation and under reasonable terms and conditions that are
demonstrably free of any unfair discrimination.

A record of the patent holder’s statement shall be retained in both the 3-A SSI files and with ANSI.

When 3-A SSI receives from a patent holder the assurance set forth in b) above, the 3-A Sanitary
Standard or 3-A Accepted Practice shall include a note substantially as follows:

NOTE – The user’s attention is called to the possibility that compliance with this standard
may require use of an invention covered by patent rights.

By publication of this 3-A Sanitary Standard or 3-A Accepted Practice, no position is taken
with respect to the validity of any such claim(s) or of any patent rights in connection
therewith. If the patent holder has filed a statement of willingness to grant a license under
these rights on reasonable and nondiscriminatory terms and conditions to applicants
desiring to obtain such a license, then the details may be obtained from 3-A SSI.

Neither 3-A SSI or ANSI is responsible for identifying all patents for which a license may be
required by an American National Standard or for conducting inquiries into the legal validity or
scope of those patents that are brought to their attention.

2.16 Records Retention Policy

The Secretariat shall retain all standards related records for one standards cycle or until the
standard is revised. This may include, but is not limited to, ballots, public comments,
correspondence, meeting notices, and minutes of meetings pertaining to the development of a 3-A
Sanitary Standard or 3-A Accepted Practice, for a period of five years or until the 3-A Sanitary
Standard or 3-A Accepted Practice is reaffirmed, revised or whichever is longer.

Records concerning the withdrawal of a 3-A Sanitary Standard or 3-A Accepted Practice shall be
retained for at least five years from the date of withdrawal or for a duration consistent with the audit
schedule, whichever is longer.

Records may be kept in an electronic format. Provisions shall be made for a back-up set(s) of
records if the original records are kept in an electronic format. At least one set of back-up records
shall be maintained at an off-site location.

Provisions shall be made to retain returned ballots in an unalterable format.

2.17 Revisions of Rules, Policies, and Procedures

Revisions of any of the rules, policies, and procedures included in these Procedures require
approval of the 3-A SSI Board of Directors.

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Procedures for the Development and Maintenance of 3-A SSI Standards and 3-A Accepted Practices

2.18 Maintenance of 3-A Standards

3-A SSI develops and revises its standards using the Periodic Maintenance method.

2.19 Procedures for the Development of a Provisional 3-A Sanitary Standard, Accepted
Practice, or a Provisional Amendment to a 3-A Sanitary Standard, Accepted Practice, or
ANS

Occasionally, there are situations that require 3-A SSI to issue a Provisional 3-A Sanitary Standard,
Accepted Practice, or a Provisional Amendment to a 3-A Sanitary Standard, Accepted Practice. In
such cases, provided that certain conditions can be satisfied, a proposed amendment may be
developed and submitted directly to the Steering Committee. The following situations include:

a.) When implementation of the Provisional Amendment may result in an improvement to the
safeguarding of life, and there is a well-established need for the prompt dissemination of
information that addresses an emergency situation or other special circumstance;

b.) When the use of the accredited procedures of the ASD would cause an undue delay in the
issuance of a related standard; and

c.) When an ASD supports the development of a Provisional Amendment.

d.) Request for Rapid Response Ballot

Any interested stakeholder, Certified Conformance Evaluator (CCE), or 3-A SSI staff member can
make a request for a Rapid Response ballot to 3-A SSI. The 3-A Steering Committee Chair, in
consultation with 3-A SSI staff and the WG Chair, will review the request and determine whether a
request for a Rapid Response ballot is justified. The following criteria will be used to determine
whether the request is justified:

The proposed revision must be to update the 3-A Sanitary Standard or 3-A Accepted Practice.

For example, requesting the use of the Rapid Response ballot solely to allow a single company’s
product(s) to be in conformance to the standard would not constitute a valid reason to use this
expedited ballot process.

e.) Steering Committee Action


3-A SSI staff, in consultation with the 3-A Steering Committee Chair and the appropriate Working
Group Chair, will develop the exact wording and changes to be made to the document. These
changes will be prepared in a ballot identified as a Rapid Response ballot and sent to the Steering
Committee per Section 2.5.4.

2.19.1 Minimum consensus body ballot period


A developer using these procedures may utilize the minimum ballot period established by their
accredited procedures or the consensus body may establish a ballot period that is not less than two
weeks.

2.19.2 Comment resolution


All comments accompanying the provisional “rapid response” ballot shall be circulated to the
consensus body in order to afford all members an opportunity to respond, reaffirm, or change their
vote. For recirculation of comments, a minimum period of not less than one week is required. An
attempt to resolve the comments received relative to the Provisional Amendment is not required.

2.19.3 Right to appeal


The right to appeal shall not be required in connection with the issuance of a Provisional
Amendment. After the standard or revision has been issued, if a directly and materially affected

15
Procedures for the Development and Maintenance of 3-A SSI Standards and 3-A Accepted Practices

party believes that the Provisional Amendment should be withdrawn, the clause for Withdrawals
shall be followed.

2.19.4 Withdrawal
A Provisional Amendment shall exist for no longer than two years from the date on which it is
approved by the ASD. If consensus is achieved and the affected standard is published, the
Provisional Amendment is superseded and shall be withdrawn. If consensus is not achieved, the
Provisional Amendment shall be withdrawn at that time, but no later than two years from the date
on which it was approved.

2.19.5 Identification of a Provisional Amendment


A standard or an amendment to a standard promulgated in accordance with these procedures shall
be referred to as a Provisional Amendment, respectively, and identified clearly as such on the
cover or title page.

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Procedures for the Development and Maintenance of 3-A SSI Standards and 3-A Accepted Practices

APPENDIX A
Protocol for Document Development

3-A Steering Committee approves development of new,


amendment, withdrawal or reaffirmation of a 3-A Sanitary Standard
or 3-A Accepted Practice and assigns project to appropriate
Work Group.

Secretariat files PINS w/ANSI (if an ANS candidate) and


sends press releases announcing project.

Work Group develops and finalizes draft. When approved by


Work Group, draft is forwarded to Secretariat.

Secretariat reviews draft for format conformance and


confirms procedural requirements were met.

Procedural
No requirements
met?

Secretariat Files BSR-8 Request for Public Review w/ANSI (if


an ANS candidate) and sends press release announcing
draft available for review and comment. Secretariat ballots
draft to Steering Committee for minimum (30) days
(electronic format) for 3-A Sanitary Standards
and 3-A Accepted Practices.

See next page


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Procedures for the Development and Maintenance of 3-A SSI Standards and 3-A Accepted Practices

Secretariat tallies votes and develops report


and records public comments

Resolution of Comments

Is draft changed Yes


substantively?

Procedural
Problems
Corrected
No

Is document a
candidate
American
National No
Standard?

Yes

3-A SSI publishes document as 3-A


BSR-9 (Final Submittal) to ANSI for Sanitary Standard or
review for compliance 3-A Accepted Practice

No ANSI approves
document as ANS

Yes

3-A SSI publishes document as American National Standard

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Procedures for the Development and Maintenance of 3-A SSI Standards and 3-A Accepted Practices

APPENDIX B

Sample Electronic Ballot 3-A Sanitary Standards Ballot


3-A {Document Name and Number} 3-A Sanitary Standards Inc.
Number {Ballot #}, Ballot Date, mm-dd-yy 6888 Elm Street, Suite 2D
This ballot must be returned by {closing date} McLean, VA 22101

For Steering Committee or Work Group Member Ballot

_____ AFFIRM
_____ AFFIRM WITH COMMENT (Comment required)
_____ NEGATIVE (Comment required)
_____ ABSTAIN (Comment required)

Name of Clause/ Editorial Comment/ Document Leader/ Resolution of


Commenter Sec. # (“E”) Proposed Change WG Chair Comments
Classification
Technical (Negative S= “Substantive
(“T”) comments without NS= non-substantive
proposed changes
will not be
considered) See
Procedures 2.5.4.1

Information and Instructions

1. The return of this ballot is REQUIRED from all voting members. A voting member
who fails to return two consecutive ballots may be removed from the voting body.

2. Affirmative votes with comment may be cast for minor or editorial changes to any
text. Include specific changes when applicable.

3. Negative votes must be accompanied by an explanation and a suggested revision


to overcome the negative. Negative votes on finding a negative from a previous
ballot persuasive do not require comments to be submitted.

4. If you are not prepared or qualified to vote affirmatively or negatively on any item,
please check ABSTAIN and provide the reason(s).

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Procedures for the Development and Maintenance of 3-A SSI Standards and 3-A Accepted Practices

APPENDIX C
Glossary of Key Terms

3-A Steering Committee - The 3-A Steering Committee is responsible for the oversight of all 3-A
Sanitary Standards and 3-A Accepted Practices. In accordance with the bylaws of 3-A SSI, the 3-A
SSI Board of Directors designates the membership of the 3-A Steering Committee. The Committee
is balanced by interest category.

American National Standard - The designation American National Standard is used to identify
any standard that has received American National Standards Institute (ANSI) approval or been
approved by an ANSI-accredited standards developer (ASD) who has been granted authority to
designate its standards as American National Standards. ANSI approval of these standards is
intended to verify that the principles of openness and due process have been followed in the
approval procedure and that a consensus of those directly and materially affected by the standards
has been achieved.

Steering Committee - The consensus body responsible for voting on the approval of proposed 3-A
Sanitary Standards or 3-A Accepted Practices as well as American National Standards and other
matters requiring Steering Committee action as provided in these Procedures. In accordance with
the ANSI Essential Requirements: Due Process Requirements for American National Standards,
the Steering Committee shall have a balance of interests as defined by the developer. For 3-A
Sanitary Standards and 3-A Accepted Practices, the Steering Committee consists of all members
and other interested parties appointed by the 3-A SSI Board of Directors.

Interest Categories - the Secretariat has defined specific interest categories or groups to help
establish the criteria for balance.
For 3-A Sanitary Standards and 3-A Accepted Practices, interest categories are defined in these
procedures appropriate for the activities of 3-A SSI. These categories are:

a) Equipment Fabricators - The Equipment Fabricators Category shall represent those persons,
companies or trade associations and their consultants who are original equipment
manufacturers (OEMs), fabricators, distributors and installers of equipment covered by 3-A
Sanitary Standards and/or 3-A Accepted Practices.

b) Processors/Users - The Processors/Users Category shall represent those persons, companies


and trade associations and their consultants who are users of dairy, and/or food processing
equipment or systems covered by 3-A Sanitary Standards and/or 3-A Accepted Practices.

c) Public Interest – The Public Interest Category represents state and local milk regulatory
officials (Sanitarians), representative(s) from academia, the USDA Dairy Programs, the FDA
and other sanitarians, consumers and others.

Interpretations Group – For 3-A Sanitary Standards and 3-A Accepted Practices, the
Interpretations Group provides official 3-A SSI interpretation of words, phrases, and criteria within
3-A Sanitary Standards and, when needed, 3-A Accepted Practices. The IG consists of 5
members designated by the 3-A SSI Board of Directors in accordance with the 3-A SSI Policy
Manual, Interpretation of 3-A Sanitary Standards and 3-A Accepted Practices.

Secretariat - The secretariat is 3-A SSI and serves as the primary administrative authority
responsible for the general coordination of 3-A SSI activities associated with development and
administration of 3-A Sanitary Standards and 3-A Accepted Practices in accordance with these
procedures.

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Procedures for the Development and Maintenance of 3-A SSI Standards and 3-A Accepted Practices

Work Groups - the Secretariat has designated Work Groups, which are responsible for overseeing
the maintenance and development of 3-A Sanitary Standards or 3-A Accepted Practices for groups
of similar equipment or materials. Designation of a WG is the responsibility of the 3-A Steering
Committee. A current list of WGs and rosters of WG representatives are maintained on the 3-A
SSI web site. Each WG is composed of experts representing fabricators of related types of
equipment, systems, and materials and representatives of the users and sanitarian interest
categories. Suppliers to OEMs, consultants of record to OEMs or consumers, may also be
designated. Their primary responsibility is to provide technical input during the development of
initial proposals or revisions and amendments to existing 3-A SSI documents.

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Procedures for the Development and Maintenance of 3-A SSI Standards and 3-A Accepted Practices

APPENDIX D
TIMETABLES
3-A SSI Activity Activity Needed Minimum Timeframe
Public Notice of Activity Notice contains only 30-day comment period
reference to action
Announcement of Notice contains information 30-day comment period if
Opportunity for Public on obtaining the full text of full text available in ANSI
Review/Comment action for review Standards Action
45-day comment period if
available in electronic
format
60-day comment period if
available by other format
Ballot results Report to Work Group, Within (30) days of the end
Steering Committee and 3- of the ballot period.
A SSI Board of Directors
Notice of Intention to Appeal To the 3-A Secretariat Within (30) days of the
notification of the action
Response to Notice of Report to appellant Within (30) days of receipt
Intention to Appeal of the Notification of
Intention to Appeal
Convening of Appeals Panel Report to all interested Within (15) days of inability
parties to resolve the issue
informally
Appeals panel decision Report to all interested Within (30) days of
parties conclusion of the hearing

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