March 7, 2013

Toni Strother, AgriculturalMarketing Specialist

National OrganicProgram, USDA–AMS–NOP

1400Independence Ave. SW.

Room 2646–So., Ag Stop 0268

Washington, DC20250–0268.

Subject: Comments from theSynthetic Amorphous Silica and Silicate Industry Association to AMS/USDA on FR 8040, Vol. 78, No.24 (February 5, 2013) Notice of Proposed Rule to Modify 7 CFR 205.605(b)

Dear Mr. Strother:

The Synthetic Amorphous Silica and Silicate Industry Association (SASSI) is a national trade association whose mission includes furthering the understanding of synthetic amorphous silica and silicate health and safety data within the industry, monitoring the regulation of synthetic amorphous silica and silicate by government, educating the public and government on the views of the industry, and consulting and cooperating with officials and agencies on matters having an industry-wide significance.

Consistent with itsmission, and on behalf of itsmembers, SASSIsubmitsthe followingcomments in response to the above-referenced Federal Register notice concerning the following proposed annotation for silicon dioxide to7 CFR 205.605(b):“Silicon dioxide—Permitted as adefoamer. Allowed for other uses whenorganic rice hulls are not commerciallyavailable.’’ Silicon dioxide is currently listed without any annotation, and SASSI recommends that the proposed annotation not be finalized.

A. Previous Comments:

SASSI submitted comments to AMS/USDA on November 11, 2011, stating, in part, that “Rice Hulls is not a one-for-one replacement for Silicon Dioxide in all relevant applications and will not serve as a replacement for anti-caking and free flow additive because of a wide range of performance and technical issues.” In addition,a member company representative attended the April 2011 NOSB meeting and presented substantiating information about SASSI’sconcern(“Additional information about Silicon Dioxide and Rice Hull Silica” Presented to the NOSB Spring Meeting, April 26-29, 2011; Cheryl A. Van Dyne, J.M. Huber, Director, Global Regulatory Affairs ). Copies of these submissions are attached here.

B. List of Recommendations:

SASSI’s position is that the proposed annotation is premature, since rice hulls have not been demonstrated to be an effective substitute for silicon dioxide. On that basis,SASSI recommends that silicon dioxide be retained without annotation in the 7 CFR Section 205.605(b) list. For the reasons explained further below, the proposed annotation language is not supported by the record. The concerns raised in the above-referenced 2011 comments have not been addressed in any depth by analysis or documentation that we are aware of, and there is not sufficient basis to suggest that rice hulls can substitute for silicon dioxide, except in rare and limited circumstances, which do not satisfy commercially available criteria. The phrase “not commercially available” is described in the preamble to include situations where rice hullslack “the ability to obtain a production input in an appropriate form, quality, or quantity to fulfill an essential function in a system of organic production or handling, as determined by the certifying agent in the course of reviewing the organic plan.” 77 FR 8043. The significant lack of functionality of rice hulls in a wide range of applications will preclude their use regardless of attempts to reformulate.

The proposed revision to the silicon dioxide listing is contrary to the March 21, 2012 conclusion of the NOP which stated: “The NOP will need to evaluate the economic impact and recordkeeping burden of the NOSB silicon dioxide recommendation before any proposed rules can be developed for public comment. Due to the limited resources that the NOP has available for standards development it is unlikely that the NOP will move this recommendation forward in the near future.” (NOP Minutes of March 21, 2012 meeting, section 6).The functionality of the organic rice hull products suggested as a substitute for silicon dioxide has not been adequately established, and the allowable uses are poorly defined. Implementation of this option will be burdensome for producers of silicon dioxide, for producers of organic products who rely on the dependable, GRAS, functionality of silicon dioxide. The concerns raised by SASSI’s comments should be addressed before any change to the silicon dioxide listing is considered.

Although SASSI does not support the annotation, if it remains a consideration, and if rice hulls are stipulated as proposed,additional emphasis that silicon dioxide is acceptable where rice hulls do not work should be included: “Silicon dioxide—Permitted as a defoamer. Allowed for other uses when organic rice hulls are not commercially available or do not function adequately in the product application.”

C. Rationale:

SASSI reiteratesits position, as presented in its November 11, 2011 comment letter:

“SASSI respectfully requests that Silicon Dioxide remain on the USDA National List of allowable ingredients for food production at 205.605(b). Based on a review by a number of our member companies, Ribus Ground Up Rice Hulls is not a one-for-one replacement for Silicon Dioxide in all relevant applications and will not serve as a replacement for anti-caking and free flow additive because of a wide range of performance and technical issues. Of significant importance in assessing the Ribus material is the recognition that the active ingredient in the Ribus material that functions as an anti-caking agent is Silicon Dioxide, but its concentration is approximately 17%. Application testing has shown that even with a 5x loading level (which provides the equivalent level of silicon dioxide) the same performance is still not achieved. Additionally, because of the excessive loading, there is a significant dilution of the treated food/beverage. This can have a detrimental impact on cost, production throughput, product performance, and of course our customers’ experience (through taste, color, mouth-feel and dilution).

Silicon Dioxideis used in many food and beverage applications as an anti-caking additive, including in soup powders, sugars, cake mixes, non-dairy creamers, salt, spices, hot chocolate, and many yeast/flour-based powdered mixes. While we acknowledge that there may be specific, limited applications where Ribus rice hulls provide acceptable performance, SASSI’s members are confident they cannot be used as a viable replacement for silicon dioxide in all of these important applications. Given the broad range of applications, and the potential downside of using a product like Ribus rice hulls, we feel that it is imperative that Silicon Dioxide remain on the USDA National List of Allowable ingredients for food production.”

These factors may make the reformulation of food products using organic rice hulls as a substitute for synthetic amorphous silica a lengthy, difficult, if not impossible, task for food producers and applications.

D. Citable Material:

In addition to the information that was provided by J. M Huber and Evonik Corporation to the NOSB in 2011, SASSI is currently re-evaluating the comparison of rice hull performance to silicon dioxide in a number of applications, anticipating that rice hulls will prove to be unacceptable in an even wider range of uses. These additional data will be made available to AMS/USDA upon completion of the re-evaluation.

We appreciate AMS/USDA’sconsideration of SASSI’s comments and concerns. We are open to meeting with you and discussing any opportunity to assist AMS/USDA in completing a comprehensive and accurate review of the proposed rule.

Please contact me to determine how SASSIcan support the efforts of the Agency.

Sincerely yours,

David A. Pavlich

Association Manager

Synthetic Amorphous Silica and Silicate Industry Association

440-897-8780

SASSI Member Companies:

–J.M. Huber Corporation

–Evonik Corporation

–Wacker Chemical Corp.

–Cabot Corporation

–Rhodia,Inc., Member if the Solvay Group

–PPG Industries, Inc.

–PQ Corp.

–W.R. Grace & Co.

SASSI Website: