Clinical Integration of Osteopathic Manipulative Medicine Family Medicine : Fibromyalgia Author: Zahava Hersh, OMS IV and Sheldon C. Yao, DO Introduction: Fibromyalgia is a chronic pain disorder of unknown etiology characterized by widespread pain, abnormal pain processing, sleep disturbances, and psychological distress. Criteria for classification of fibromyalgia by the American
Microsoft word - tac 10-23-2008.docTECHNICAL AFFAIRS COMMITTEE
Introductory Remarks by Steve Lomax
The meeting was called to order at 12:30 p.m. on Wednesday, October 22. The following member company representatives and guests were in attendance: Scott Moss Tate and Lyle Ingredients Americas, Inc. *Indicates part-time attendance via conference call. II.
Mr. Lomax reminded the committee of their obligations under the CRA Antitrust
Mr. Lomax noted that participation by members in all CRA projects is voluntary and that no
confidential business information will be received by CRA or shared among members.
III. The Committee approved the minutes from the April 2008 meeting as written.
The Committee discussed activities of other related associations:
Mr. Lomax noted that the American Association of Cereal Chemists annual meeting
was recently held in Hawaii and that the CRA Awards Committee identified two
winners from Kansas State and Iowa State for the best posters on corn wet milling.
The next AACC annual meeting will be held in Baltimore on September 13-16, 2009.
b. Ms. Purvis reported that Cargill has proposed to the American Society of Brewing Chemists (ASBC) that it adopt CRA color method E-19. AABC is considering the proposal. c. Mr. Mally reported that the Association of Official Analytical Chemists now offers web-access for members to all methods. The next AOAC annual meeting will take place in Philadelphia on September 13-16. The Committee discussed the American Oil Chemists Society’s consideration of methods for detection of mycotoxins (aflatoxin, fumonisin, vomitoxin) using combination text kits and procedures presented by Neogen, Romer and Vicam. The Committee noted that these kits do not work well on gluten meal and feed products and did not believe that GIPSA had approved their use for corn byproducts. While aflatoxin is the only mycotoxin for which FDA has established action levels, it was noted that the State of Texas has adopted limits for fumonisin and FDA has published guidance levels for fumonisin. Mr. Moss noted that ADM has conducted a study to validate aflatoxin test kits but the results show the test kits produce erroneous results that are biased toward high readings. e. Mr. Knight noted that the GMA divested the SAFE™ food safety audit program to QMI/SAI Global. The program will not be harmonized with GFSI. Mr. Lomax reminded the Committee of FDA’s plan to utilize third-party certification programs to protect the food supply. The Committee approved support of reduced auditing scrutiny for facilities that demonstrate appropriate systems are in place and that FDA should certify audit programs by AIB, GFSI, and QMI/SAI.
f. Ms. Hipple reported that the International Society of Beverage Technologists (ISBT)
continues to rely on the inaccurate and time-consuming (7 days) Japanese method
for detection of TAB. The Committee agreed that there has never been a TAB issue
in the U.S. and that TAB historically has only been a problem in fruit juices in warm,
tropical climates. Ms. Hipple noted that Tate & Lyle is working to develop a rapid
test method. Ms. Hipple also noted that the ISBT 72-hour wash rule was finalized
and that now there is a push to extend the wash rule to all tankers. Ms. Hipple
recommended that the CRA conduct a technical presentation on HFCS and
the scientific basis for our ad campaign at ISBT’s Sweetener Committee
meeting in Fort Lauderdale on April 27, 2009. The Committee requested a
summary on the placement of ads for the campaign.
Mr. Bernens and Mr. Eury discussed Syngenta’s alpha-amylase corn variety, a high value
specialty grain with a target market for dry grind ethanol producers. The business model
is based on “closed-loop” systems with no expectation to export byproducts, but to sell
wet DDGS to local feedlots. The FDA has reviewed and approved the variety for food
and feed safety and now it is under review by USDA for deregulation. Current
production is regulated by USDA and it is expected that planting next spring will be
subject to regulations for isolation, cleaning out planters, etc. Deregulation could occur
before harvest in fall 2009. Syngenta has obtained approvals for the variety in Canada,
New Zealand, Australia and the Philippines, and will seek approval in other countries.
In 2007, approximately 15,000 acres were planted in the western cornbelt (Nebraska and
Kansas), but the acres planted in 2008 were reduced by approximately 2,000 acres. The
business model currently is based on planting the variety within a 50-mile radius of dry
grind ethanol facilities that would process 5-20% amylase corn and 80-95% No.2 corn.
Ms. Purvis noted the concerns of starch manufactures, namely the potential impact of
the amylase on viscosity of modified starches and the unknown percent of amylase corn
that will affect viscosity. Mr. Bernens noted that contamination of the corn supply
should not occur in a closed-loop system and that while there is always a risk, Syngenta’s
efforts to reduce pollen flow will ensure that amylase will be diluted to levels so low that
it is unlikely to have an impact on other processes, such as starch manufacturing. Mr.
Eury noted that Syngenta has taken the work as far as they can as a seed company and
that they are setting up face-to-face talks with CRA member companies. Mr. Eury noted
that a strip test will be available for testing incoming corn for the amylase variety and
that Syngenta will employ an end-process test to ensure that dry grind facilities are
getting good value for use of the variety. Following the discussion with Syngenta, the
Committee agreed to send a letter, within the next three months, to Syngenta
(with a copy to FDA and USDA) that outlines the concerns for potential impacts
on starch viscosity and the general market if the amylase trait appears in export
shipments. Mr. Lomax will send an email to the Committee requesting feedback
on issues to address in the letter. The Committee representatives will solicit
feedback from their legal departments. [Any draft letter to Syngenta will be subject to
Mr. Brenner noted the EU is moving slowly on approvals of new biotech events, continuing the disruption in the EU gluten feed market. Syngenta’s Agri-Sure rootworm and Monsanto’s VT rootworm varieties have been stuck in European Food Safety Agency review for more than three years and are not expected to move forward until mid-to-late 2009. The U.S. won a WTO case against the EU’s approval delays, and negotiations are ongoing regarding setting timelines for regulatory decisions. Mr. Brenner also noted that European grain and feed importers have raised awareness of the need for the European Commission to establish tolerance levels for varieties approved in exporting countries but not in the EU. However, the European Commission failed to present a proposal before its August recess and they are unlikely to go further than allowing 0.1% tolerance +/- 0.2% for testing uncertainty. Mr. Brenner noted that the American Seed Trade Association has suspended its Market Choices program that helped farmers to properly channel sales of varieties with traits not approved in the EU. Mr. Brenner noted that USDA’s APHIS recently published a proposal for a new process for approving biotechnology that codifies previously informal APHIS policies on stricter planting requirements for developmental biotech crops, incidents of adventitious presence, recalls, and record-keeping requirements for seed companies. Working with the Ag Biotechnology Planning Committee, the CRA will support this proposal. Mr. Brenner noted that Codex has issued non-mandatory guidelines for rapid safety evaluations of biotech varieties approved in the country of export but not the country of import. The guidelines outline the process for assessing allergenicity and toxicity of varieties. The Codex Nutrition Committee will meet in November to address the definition of dietary fiber, but there is little hope of advancing a fiber definition because the U.S. government will not take a position until completion of a pending FDA rulemaking. Mr. Brenner noted that Codex may establish a special task force on animal feed to develop new contaminant standards for animal feed and to create lists of acceptable substances which may be used in animal feed. Mr. Brenner reminded the Committee that FDA is reviewing comments, including CRA’s, in response to its advanced notice of proposed rulemaking for nutrition labeling. An FDA proposal is not expected until summer/fall 2009. VII.
Enzymatic Corn Wet Milling
Dr. Singh presented on advances in enzymatic corn wet milling and his proposal to
evaluate how the process affects pasting properties (RVA profiles) of starch and
composition (crude fat, protein, ash, residual starch and neutral detergent fiber) of
coproducts (germ, corn gluten meal and fiber). Under his proposal, the data would be
compared with pasting properties and coproduct composition from conventional wet
milling process for dent and waxy corn. Mr. Lomax will circulate Dr. Singh’s
proposal and presentation and the Committee will discuss the subject with
company R&D personnel to gauge their level of interest. The Committee
directed the CRA to discuss enzymatic corn wet milling with Genencorp and to
inquire whether they intend to fund Dr. Singh’s proposed research.
Food Chemicals Codex/USP
The Committee discussed USP’s September-October publication of proposed revisions
to their Corn Oil Monograph and sterol composition methods. Comments are due on
the proposals by December 15. The Committee requested Mr. Lomax to circulate
the proposals via email and the Committee will obtain comments from colleagues
and report back to the CRA. The CRA will summarize the comments and
transmit them to USP.
IX. ARS Research Program for Quality and Utilization of Agricultural Products
Mr. Lomax discussed USDA’s review of ARS National Program 306 to conduct
research on improving the quality and utilization of agricultural products. The
Committee directed Mr. Lomax to circulate a notice of the program’s review of
research priorities and request the Committee’s comments for submittal to ARS.
Ms. Purvis reported on the collaborative study to develop and validate a combined
method for acetaldehyde (2A) and IVA. She noted that results using the draft methods
show close agreement and that the method will save both time and expense. If the CRA
can adopt the method, the Committee approved proposing the method to ISBT. Ideally
the collaborative will include participation by eight labs, consistent with AOAC criteria.
Cargill will arrange a conference call to discuss results to date and, if possible, the
Committee will approve the method before their next meeting.
Mr. Tepoorten and Mr. Mally presented the development and validation of a new
method by Corn Products to detect ethylene glycol in sorbitol. The method is needed to
respond to inquiries from pharmaceutical companies regarding compliance with July
2008 USP residual solvent requirements for control of residual solvents. Mr. Lomax
will circulate the draft method for review by the Committee and set-up a
conference call to discuss next steps. The long-term goal is for the CRA to adopt the
method and, in turn, to propose that USP adopt the method.
Mr. Kok presented an updated combined ash method. The Committee reviewed the
method and recommended various changes. Mr. Kok and Mr. Lomax will
incorporate the suggested edits and circulate the draft method for another round
of review and comment. Mr. Lomax will schedule a conference call within the
next month to approve the revised method.
Analytical Methods Reformatting
Mr. Moss identified Mr. Dick Light (retired from ADM) as a potential candidate to work
on the Committee’s project to consolidate and re-format the CRA analytical methods.
Mr. Moss will follow-up with Mr. Light about his availability to work on the
project and report back to the Committee.
XII. Carbohydrate Check Sample Program
Ms. Kohler presented a status update on the Carbohydrate Check Sample Program
(CCSP). She noted that, as requested by the Committee, Silliker has been sending email
notifications when samples have been shipped. For labs that fail to submit results on
time, Silliker has been issuing a reminder email and then Ms. Kohler follows up directly
with the labs. The Committee agreed to notify CRA if backup personnel should be
added to the current email distribution. Ms. Kohler also noted the switch in results
reporting forms, from .pdf to .doc format, which allows the labs to more easily enter and
submit their results. Ms. Kohler noted that two new tests, 2 amino-acetophenone (2AP)
and isovaleraldehyde (IVA), have been added for the 2008 series and for all HFCS
samples (i.e., both HFCS 55 and HFCS 42). Ms. Kohler noted that Silliker continues to
struggle with developing an online reporting system. The Committee directed the
CRA to ensure any contract renewal with Silliker to manage the CCSP should
include requirements for online results reporting.
Ms. Kohler noted that some countries (e.g., Chile, Mexico and China) are requesting
certificates of origin or phytosanitary certificates, prior to processing the samples
through customs. The Committee directed CRA to include a ‘country of origin’
certificate with the Series 8 samples and a 1-page sheet that answers some of the
other common questions raised by foreign customs officials.
The Committee initiated review of existing CRA methods. The Committee suggested
edits to Method A-8 for Crude Fiber and directed Mr. Lomax to re-circulate this
method and the other ten oldest methods to the Committee, for review and
comment. Mr. Lomax will update the methods based on the Committee’s
recommended changes and re-circulate the methods for approval via conference
call or at the next meeting.
Adjournment and Next Meeting
The meeting adjourned at 11:30 a.m. on Thursday, October 23, followed by a tour of the National Renewable Energy Lab, in Golden, Colorado. The next meeting of the Committee was proposed for March 31-April 1, 2009, in Lafayette, Indiana, including a proposed visit to Purdue University’s Whistler Center for Carbohydrate Research.
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