2012 Annual Report (PDF) - 3-A Sanitary Standards

3-A Sanitary Standards, Inc.
2012 Annual Report
Moving Ahead in Our Mission

Officers
Ronald Schmidt, Chair
University of Florida
Dan Meyer, Vice Chair
American Dairy Products Institute
Carl Buell, Secretary
Leprino Foods Company
Lou Beaudette, Treasurer
Admix, Inc.
Our Mission
It is the mission of 3-A Sanitary Standards, Inc.
to enhance product safety for consumers of
food, beverages, and pharmaceutical products
through the development and use of 3-A
Sanitary Standards and 3-A Accepted Practices.
Directors
Kenneth Anderson
Harold Wainess & Associates
Warren S. Clark, Jr.
Consultant
Lyle Clem
3-A Steering Committee
Ray Dyke
Agri-Mark, Inc.
Jon Gardner
International Dairy Foods Association
Larry Hanson
Johnsonville Sausage, LLC
Robert F. Hennes
Chief, FDA/CFSAN-Milk Safety Branch
Ken Vorgert
USDA/AMS, Dairy Grading Branch
F. Tracy Schonrock
Consultant
David Seckman
Food Processing Suppliers Association
Counsel
Hugh Webster
Webster, Chamberlain & Bean
Committee Leadership
Communications & Education Committee
Larry Hanson, Johnsonville Sausage, LLC
Finance Committee
Lou Beaudette, Admix, Inc.
3-A SSI Growing ‘Brand’ Recognition
3-A Sanitary Standards, Inc. works on behalf of a diverse community of regulatory
sanitarians, fabricators, and processors with a common interest in serving the public good.
3-A SSI has established a strong and positive track record of developing criteria for the
hygienic design of food processing equipment. This year, 3-A SSI expanded and enhanced
recognition of 3-A Sanitary Standards, 3-A Accepted Practices and the 3-A Symbol
program across the food processing industry and others.
3-A SSI achieved major progress this year in promoting broader recognition of the
organization as well as the valuable ‘products’ it provides to the industry and the goal of
food safety. 3-A SSI gained new recognition in the academic community by providing
travel support for qualified and motivated students to participate in the 3-A SSI Annual
Meeting and education program. Important recognition of 3-A SSI was also gained in
the medical products industry as stakeholders search for design criteria that may have
potential application for the cleanability of reusable medical devices. A major new project
announced this year to develop a new American National Standard for the sanitary design,
materials of construction, and fabrication techniques of dairy and other food and beverage
equipment will bring new interest and participation in the work of 3-A SSI.
3-A SSI anticipates public concern about food safety will continue to grow among the
public, regulatory professionals, processors and equipment fabricators in the years ahead.
Attention will be focused on the entire food safety chain and new ways to assure the public
health. In particular, proven standards and credible voluntary third party certification
programs will become increasingly important to meet regulatory objectives in the coming
years.
In the year ahead, 3-A SSI will maintain a very active outreach program to key audiences
of processors, regulatory professionals, fabricators and others through participation in
training seminars, conferences and trade shows. 3-A SSI has the opportunity to develop
new and improved knowledge resources to serve the growing interest in hygienic
equipment design. We invite the active participation of committed volunteers to help us
grow as a valued information and education resource.
Third Party Verification Coordinating Committee
F. Tracy Schonrock, Consultant
Interpretations Committee
Randy Elsberry, FDA Regional Dairy Specialist
Office of Regulatory Affairs, Pacific Region
3-A Steering Committee
Lyle Clem, Electrol Specialties Company
P3-A Steering Committee
Paul Hoblitzell, Eli Lilly Co.
3-A SSI Staff
Timothy R. Rugh, CAE, Executive Director
Nate Wall, Director, Standards and Certification
Philomena Short, Technical Assistant
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The mission objectives of 3-A SSI include:
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Develop, maintain and publish uniform
standards and practices for the sanitary
(hygienic) design, fabrication, installation
and operation of equipment and
machinery.
Use state-of-the-art, science-based
expertise for the development of sanitary
standards and accepted practices.
Harmonize with global standards and
guidelines as appropriate.
Promote the use of 3-A Sanitary
Standards, 3-A Accepted Practices, and
the 3-A Symbol.
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Authorize use and maintain the integrity
of the 3-A Symbol.
Maintain a uniform system to regulate
and enforce proper use of the 3-A
Symbol to best enhance consumer
product safety.
Provide education concerning sanitary
design principles, application of 3-A
Sanitary Standards and 3-A Accepted
Practices, and use of the 3-A Symbol.

3-A Symbol Program Reaches High Mark
Participation in the 3-A Symbol program this year reached the highest total since the
new Third Party Verification (TPV) inspection was introduced in 2003. The organic
growth in the number of new licensees over the past four years has far exceeded
the number of discontinuations and 2011 was a record year for new 3-A Symbol
applications. The leading reasons for withdrawals in the 3-A Symbol program continue
to be company consolidations or product discontinuations.
3-A SSI recorded a large number of renewal TPV inspections due this year for the
continuation of a 3-A Symbol authorization. All authorized 3-A Symbol holders are
required to obtain a complete TPV inspection of licensed equipment at least once
every five years, or whenever there is a significant change in materials or production
processes.
The TPV inspection requirement was initiated in 2003 as a requirement for a fabricator
or marketer to obtain authorization to use the 3-A Symbol. The TPV requirement
applies to all equipment built to 3-A Sanitary Standards that is licensed to display the
3-A Symbol. A licensee must engage a credentialed inspection professional, a Certified
Conformance Evaluator (CCE), to conduct an on-site evaluation of finished equipment
and other product attributes to affirm the equipment conforms to provisions of the
applicable 3-A Sanitary Standard. Any deficiencies discovered in an inspection must
be corrected before the equipment can be authorized to display the 3-A Symbol.
Equipment manufacturers that do not comply with the TPV inspection requirement
risk losing the authorization to use the 3-A Symbol.
Since the TPV program was implemented, more than 1,000 TPV inspections have
been completed at fabrication facilities in the U.S. and 25 other countries around the
world to verify the equipment conforms to 3-A Sanitary Standards. Inspections have
been completed for equipment fabricated in the U.S. and other countries including
Argentina, Austria, Belgium, Brazil, Canada, China, Denmark, England, Finland,
France, Germany, Israel, Italy, Japan, Korea, Mexico, Netherlands, New Zealand,
Poland, Portugal, Spain, Sweden, Switzerland, Taiwan, and Thailand.
Strong public interest in the 3-A Symbol program was reflected this year in the
number of visitors to the on-line, searchable database of 3-A Symbol licensees. The
data includes all of the current fabricators that conform to 3-A Sanitary Standards
for dairy and food processing equipment and meet provisions of the 3-A Symbol
authorization program. Since addition of the database last year, web statistics show
the 3-A Symbol certificate information has ranked consistently at or near the top
of pages viewed each month by site visitors. The public information offers detailed
information on models/equipment covered under a company’s license to assist
regulatory sanitarians, processors, equipment fabricators, and other interested parties.
The information is searchable by the unique authorization number, equipment type/
standard or company name. A copy of the actual authorization certificate may also be
printed from the database.
The TPV requirement, combined with easy access to licensee information, has
enhanced the level of integrity and recognition of the 3-A Symbol for everyone
concerned with the safety of consumers of food, beverages and pharmaceutical
products, fulfilling one of the primary mission objectives of 3-A SSI.
Introduced in 1956, the 3-A Symbol is a registered mark used to identify equipment
that meets 3-A Sanitary Standards for design and fabrication. Voluntary use of the 3-A
Symbol on dairy and food equipment conveys assurance that equipment meets sanitary
standards, provides accepted criteria to equipment manufacturers for sanitary design,
and establishes guidelines for uniform evaluation and compliance by sanitarians.
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Users Affirm 3-A ‘Brand’ Value
Data collected from 3-A Symbol holders this year underlines the
perceived importance of sanitary equipment design and display of the
3-A Symbol for food processing equipment. The customer feedback
affirms the work of 3-A SSI over the past four years to reinforce the
‘3-A value’ among the principal stakeholder groups of 3-A SSI -
processors, fabricators, and regulatory sanitarians.
3-A SSI Reaches
Important New Audiences
The data showed the leading reasons for seeking 3-A Symbol
authorization were:
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Our customers ask for equipment covered by the 3-A
Symbol.
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We want to be an industry leader.
We believe it is important to provide the safest equipment
from the sanitary design perspective.
Most new 3-A Symbol applicants relied on the 3-A SSI web site
for information on the 3-A Symbol and the application process. A
large number of respondents worked in conjunction with a Certified
Conformance Evaluator (CCE) to complete the application process.
The respondents indicated the company planned to promote
the company’s 3-A Symbol authorization to current/prospective
customers in numerous ways, including:
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Brochures and literature
In advertising, on our web site, and in equipment
pamphlets
Product line sheet as well as web site marketing ads
Exhibitions and by product launch materials
E-mail, ads in magazines, exhibits, brochures
Research on the 3-A ‘brand’ value was conducted in 2008 and a
series of new products and outreach initiatives were implemented
each year since to promote more focused and consistent messages to
all stakeholder groups on the true benefits of the 3-A Symbol. These
resources included new marketing tools for 3-A Symbol holders,
video resources, ‘white papers’, and extensive outreach activities.
3-A SSI announced the first recipients of a new 3-A SSI Student
Travel Scholarship Award this year. The award is intended to help
motivated, career-oriented students to participate in the annual
education program of 3-A SSI and gain comprehensive knowledge
about sanitary design for food processing equipment and systems.
Five students received the award and participated in the 3-A SSI 2011
programs on May 17-20 at the Wyndham Milwaukee Airport Hotel
& Convention Center in Milwaukee, WI. The student recipients
represented Texas Tech University, Michigan State University,
Pennsylvania State University, and the University of Minnesota.
According to Dr. Ronald Schmidt (University of Florida), chair of
3-A SSI and long-time educator, “Food safety has become a highly
important emphasis in food science and food microbiology curricula.
However, sanitary equipment design, a critical element of food
safety, is not often covered in depth in our programs. The 3-A SSI
program provides a truly special opportunity for future food industry
professionals to supplement their educational experience, gain indepth
knowledge about sanitary equipment design in ‘the real world’
and network with a truly diverse group of industry leaders.”
3-A SSI continued its liaison with dairy representatives from emerging
markets around the world as part of the U.S. Department of
Commerce Special American Business Internship Training Program
(SABIT). In April, 3-A SSI met with a group of dairy industry
professionals from Armenia, Azerbaijan, Georgia, Kazakhstan,
Kyrgyzstan, Moldova, Tajikistan, Ukraine, and Uzbekistan. 3-A
SSI briefed the delegates on 3-A Sanitary Standards, 3-A Accepted
Practices and the 3-A Symbol. SABIT’s Dairy Processing and
Packaging program aims to give participants a comprehensive
understanding of the dairy industry in the U.S., with an emphasis
on processing technologies, processing and packaging equipment,
production automation, industry standards, safety regulations, strategic
planning, marketing techniques, and other important industry topics.
3-A SSI provided a briefing on 3-A Sanitary Standards design
criteria at a public workshop on Reprocessing of Reusable Medical
Devices on June 9 at the FDA White Oak Campus in College Park,
MD. The workshop planners sought more about the history of
3-A Sanitary Standards in developing food processing equipment
standards and design principles that may have potential application
to reusable medical devices for cleanability. The workshop attracted
approximately 150 representatives, most from the medical
instrumentation industry. The workshop was coordinated by the
FDA Center for Devices and Radiological Health (CDRH).
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3-A SSI reached out to many other audiences in the U.S. this year,
including current 3-A Symbol holders and many potential new
‘customers’. The slate of events included a series of training seminars
oriented to the work of professional regulatory sanitarians as well as
participation in several major dairy industry trade shows. 3-A SSI
also participated in the World Congress of the European Hygienic
Equipment Design Group.
April 12 SABIT Dairy Processing & Washington, DC
Training
June 9
FDA Public Workshop College Park, MD
Reprocessing of Reusable
Medical Devices
July 11-13 National Association of Rapid City, SD
Dairy Regulatory Officials
July 31-Aug. 3 IAFP Annual Meeting Milwaukee, WI
August 3 FDA Training Workshop Harrisburg, PA
September 19-21 International Dairy Show Atlanta, GA
September 14 FDA Training Workshop Rockford, IL
September 22-24
EHEDG World Congress
on Hygienic & Design
Engineering
Ohrid, Former
Yugoslav Republic
of Macedonia
November 1-4 Process Expo Chicago, IL
Volunteer Certified Conformance Evaluators (CCEs) supported the
FDA training workshops including Gabe Miller and Robert Elbich.
3-A Steering Committee Chair F. Tracy Schonrock contributed a
presentation for the EHEDG World Congress.
The 3-A SSI web site is now available for translation in 53 different
languages. 3-A SSI added a new translation utility which can be
used to view content on virtually all of the pages of the 3-A SSI site,
including 3-A Symbol authorization certificate information.
3-A SSI Acts
to Protect 3-A Symbol
Since submitting its application to authorities last year, 3-A SSI
has provided supplemental information to support its request
for official trademark registration of the 3-A Symbol in China.
The trademark registration of 3-A SSI is intended to help raise
general awareness of the mark and 3-A SSI’s property rights. Under
international trademark registration rules, registered protection of
the mark in China is due to become final around mid-2012, unless
a provisional refusal is made by the Chinese Trademark Office. The
official registration of the mark in China will enhance the ability
of 3-A SSI to enforce its property rights in China and obtain relief
from infringing parties in a legal proceeding. 3-A SSI may seek
registration of the mark in other countries at a later date.
In an era of expanding international commerce in processing equipment
and wider industry use of equipment built to 3-A Sanitary Standards,
3-A SSI continues to urge potential buyers of equipment to
exercise diligence and caution in specifying or purchasing equipment.
A casual on-line search today will yield literally hundreds of manufacturers
or marketers of food processing equipment. Many of these entities
state claims such as ‘meets 3A’, ‘conforms to 3A standards’, or the
equipment may include ‘3A’ in a model name or designation. Such
references attempt to capitalize on the broad, positive recognition of
the 3-A Symbol by suggesting the equipment meets the criteria for
3-A Symbol authorization. Unless the supplier has verified conformance
through the voluntary 3-A Symbol licensing program, the
buyer is solely responsible for verifying whether the equipment meets
the desired (and expected) sanitary design and fabrication criteria.
3-A SSI maintains a special ‘buyer beware’ resource on the 3-A SSI
web site to help processors, consumers, equipment specifiers and others
identify equipment sellers that make false or misleading claims of
conforming to the sanitary design or fabrication criteria of 3-A Symbol
authorization. The resource lists companies and marketing web
sites that feature misleading or false information about the sanitary
design of products used widely in dairy and other food processing
applications. Several updates were made to the information this year.
3-A SSI licenses use of the 3-A Symbol to fabricators to identify
equipment that meets 3-A Sanitary Standards for design and fabrication.
Voluntary use of the 3-A Symbol by dairy and food equipment
fabricators assures processors that equipment meets sanitary
standards, provides accepted criteria to equipment manufacturers
for sanitary design, and establishes guidelines for uniform evaluation
and compliance by sanitarians in the U.S.
3-A SSI Recognizes
Volunteer Service
Introduced in 2008, the 3-A SSI Volunteer Service Awards recognize
the extraordinary dedication and commitment of individuals who
contribute to the development of voluntary standards and the
mission of 3-A SSI. Nominations for the awards are made by fellow
volunteers from the three stakeholder groups in 3-A SSI—regulatory
sanitarians, fabricators, and processors—and others.
Winners of the 3-A SSI Volunteer Service Awards for 2011 included:
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Robert Semerad (USDA retired) received the Leadership
Service Award for outstanding service to 3-A SSI voluntary
standards development and significant contributions to the
mission of 3-A SSI.
Lyle Clem (Electrol Specialties Corp.) received the
Advancement Award for outstanding accomplishments on
behalf of 3-A SSI.
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3-A SSI Solidifies
Role in Education
3-A SSI reinforced its positive role as a valued education resource
this year with comprehensive education on leading topics on
sanitary design at the 3-A SSI Annual Meeting in Milwaukee.
A full-day education program, ‘3-A: The Complete Sanitary
Approach’, explored the ‘core’ elements of 3-A Sanitary Standards
and sanitary design of equipment and assessed the many other
complex factors and challenges beyond the construction of discrete
units of ‘3-A’ equipment’ that can potentially impact the equipment,
systems, facility and the goal of food safety. The program theme
emphasized that the new reality of food safety requires a firm
understanding of ‘3-A’ and all of the potential threats to sanitary
design. Topics and presenters for the program included:
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3-A: The Complete Approach to Sanitary Design — Joe
Stout, Commercial Food Sanitation LLC
The Facility and Installation Requirements — Dennis
Glick, USDA Dairy Grading Branch
Keeping it ‘3-A’: Maintenance and Training — Dan
Erickson, Harold Wainess & Associates
The 3-A Symbol and Oversight — Tracy Schonrock, Chair,
3-A Steering Committee
Third Party Verification: What Have We Learned? — Lyle
Clem, Electrol Specialties Co., Dan Erickson, Harold
Wainess & Associates
Regulatory Sanitarian Perspectives — Dennis Glick, USDA
Dairy Grading Branch, Randy Elsberry, Regional Dairy
Specialist, FDA Office of Regulatory Affairs, Pacific Region.
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New Food Safety Legislation and Industry Perspectives -
Dr. Ron Schmidt, University of Florida
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Simplified Sanitary Design Solutions — Stuart Salvador,
Paul Mueller Co.
EHEDG Design Guidelines for Separators — Reinhard
Moss, Head of Research & Development, GEA Westfalia
Separator Group GmbH
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When and How is Passivation of Stainless Steels Needed? -
Dick Avery, The Nickel Institute
The program also featured several interactive sessions for all
participants to exchange views on technical subjects and criteria
under review within the various 3-A SSI Work Groups.
3-A SSI Enhances Professionalism
of Inspection Program
3-A SSI maintains an accreditation program for Certified
Conformance Evaluators (CCEs). CCEs are independent
equipment inspection professionals accredited by 3-A SSI to verify
the conformance of equipment in the TPV inspection program.
The TPV inspection is a requirement of the 3-A Symbol licensing
program, P3-A Symbol licensing and other voluntary 3-A SSI
certificate programs.
3-A SSI worked this year to advance the knowledge and skills of its
CCEs during a year of very high demand for new and renewal Third
Party Verification (TPV) inspections. In the past year alone, the
CCEs performed more than 150 equipment TPV inspections for the
five-year renewal or new 3-A Symbol applications.
The TPV Coordinating Committee, consisting of regulatory
sanitarians, fabricator and processor representatives, supervised
a special training seminar for CCEs. Seminar participation
is encouraged for maintenance of CCE accreditation. The
Committee coordinated a series of phone conferences throughout
the year to establish and revise TPV Program procedures and
exchange information on the application of 3-A Sanitary
Standards and other hygienic design issues relating to the
performance of TPV inspections. The Committee also published
several bulletins to provide guidance on consistent and uniform
CCE inspection services. The new bulletins are available on the
3-A SSI web site.
3-A SSI Begins
Revamp of Standards
3-A SSI announced the development of a new base or “A-level”
standard for the sanitary design, materials of construction, and
fabrication techniques of dairy and other food and beverage
equipment used to handle, process and package consumable products
where a high degree of sanitation is required. 3-A SSI is developing
the “A level” standard as an American National Standard and has
invited all interested parties to participate in the major project.
The primary purpose of the new comprehensive standard is to help
streamline the upkeep of numerous 3-A Sanitary Standards which
are specified for the processing of milk and dairy products. The new
standard may also be beneficial to other industries where specific
design criteria are desired for processing equipment that comes into
contact with food products or other comestibles.
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The new 3-A SSI “A level” standard will encompass key criteria
which are common to 3-A Sanitary Standards. Some of these key
criteria include definitions of important terms, acceptable materials
and testing requirements, and fabrication details. Unlike other types
of standards, 3-A Sanitary Standards relate to the cleanability of
processing equipment.
In conjunction with the new “A level” standard, 3-A SSI will
develop the technical requirements applicable to specific types of
equipment contained in a series of revamped “B-level” standards.
3-A SSI currently maintains 69 individual 3-A Sanitary Standards
encompassing virtually all the major types of equipment involved
in the processing and transport of fluid milk and dairy products.
Under the new tiered system of standards, 3-A SSI will be able to
more easily update the common criteria for its broad inventory of
equipment standards.
3-A SSI relies on a network of dedicated subject matter experts
from all interest groups to participate in the consensus process for
developing and maintaining the large inventory of essential 3-A
Sanitary Standards and 3-A Accepted Practices. At the direction of
the 3-A Steering Committee, 14 Working Groups (WGs) coordinate
the drafting of new or revised documents within particular groups
of related equipment. All 14 WGs mobilized this year to revise
current documents, create new standards, or in some cases, withdraw
a document. Collectively, the WGs devoted hundreds of hours of
discussion via phone conferences and meetings.
Among the key accomplishments this year:
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Convened a new Working Group to address the
development of the new “A level” Standard. a major, yet
innovative, shift in the way 3-A SSI will develop sanitary
standards. With an A/B level standards system, 3-A SSI
will realize much higher efficiency by streamlining the
standards update process.
The following 3-A Sanitary Standards and 3-A Accepted
Practice revisions were published: 20-27 (Multiple-
Use Plastic Materials), 29-03 (Air Eliminators), 35-04
(Blending Equipment), 74-04 (Sensor and Sensor Fittings
and Connections Used on Equipment) and 85-02
(Double-Seat Mixproof Valves).
A new 3-A Accepted Practice was published, 612-00, Plant
Environmental Air Quality.
Quarterly Standards Developers’ conference calls were
continued to support the effectiveness and efficiency of
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leaders and participants in the consensus development
process.
Over 175 conference calls were held to develop and
revise the content of the 3-A Sanitary Standards and 3-A
Accepted Practices within the Work Group document
subgroups.
Approximately 34 letter ballots were completed.
There currently are 76 active standards development and
revision proposals.
This year 3-A SSI attained re-accreditation by the American National
Standards Institute (ANSI) as a Standards Developer Organization.
ANSI accreditation signifies the new procedures meet the Institute’s
Essential Requirements for openness, balance, consensus and due
process. Formal accreditation provides the opportunity for 3-A
SSI to submit new standards developed in accordance with ANSI
requirements as American National Standards.
Pharmaceutical (P3-A) Standards
A series of revisions to the current ANSI P3-A
pump standard were circulated for a public
review and ballot. The revisions were approved
and a copy of the revised standard was issued
in early 2012.
The Pharmaceutical 3-A (P3-A) Council
continues to work on four other new standards
projects, including Agitated Filter Dryers,
Vessels and Agitators, Mills and Classification
Equipment, and Process Heat Exchangers.
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3-A Sanitary Standards Inc.
6888 Elm Street, Suite 2D
McLean, Virginia 22101-3829
PH: 703-790-0295 FAX: 703-761-6284
www.3-a.org