NOP: Sunset Review (2012) Proposed Rule - Organic Trade Association
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NOP: Sunset Review (2012) Proposed Rule

February 13, 2012

Toni Strother, Agricultural Marketing Specialist
National Organic Program, USDA–AMS–NOP
1400 Independence Ave., SW.
Room 2646–So., Ag Stop 0268
Washington, DC 20250–0268

RE: National Organic Program; Sunset Review (2012)

Comment on Docket number AMS–NOP–09–0074; NOP–09–01PR

Dear Ms. Strother:

Thank you for the opportunity to comment on the proposed rule addressing the 2012 Sunset Review of substances on the U.S. Department of Agriculture’s (USDA) National List of Allowed and Prohibited Substances (National List). This proposed rule would continue, without change, the exemptions (use) and prohibitions for multiple listings on the National List for 5 years after their respective sunset dates. This proposed rule would also amend the exemptions (use) or prohibition for 7 substances and remove the exemption for 3 substances on the National List.

The Organic Trade Association (OTA) is the membership-based business association for organic agriculture and products in North America. Its members include growers, shippers, processors, certifiers, farmers’ associations, distributors, importers, exporters, consultants, retailers and others. OTA’s Board of Directors is democratically elected by its members, and its mission is to promote and protect the growth of organic trade to benefit the environment, farmers, the public and the economy (http://www.ota.com/). OTA represents hundreds of certified operations that will be impacted by the
final rule.

In summary, OTA supports the continued exemptions to the National List as proposed. We also support the proposed removal of low-methoxy pectin and potassium iodide from § 205.605 of the National List. With respect to the proposed amendments, OTA is in support of the revised annotations for chlorine, lignin sulfonate, yeast, hops, and high-methoxy pectin.

OTA supports the proposed amendment for colors provided the NOP clarify that synthetics on the National List at § 205.605(b) may be used as solvents, carriers and preservatives. We also request that upon issuance of the final rule, the NOP provide a compliance date of one year from the effective date of the amended listing.

OTA does not support the proposed amendment to the listing of Streptomycin. Consistent with our comments for tetracycline, OTA supports the complete phase-out of antibiotics in organic tree fruit production. However, we’re concerned that the proposed deadline of 2014 for the use of streptomycin in organic apple and pear production is not based on scientific evidence, and will not allow for the time needed to identify and develop commercially viable alternatives.

OTA respectfully submits the following more specific comments on the NOP Proposed Rule:

Chlorine on § 205.6011(a)

OTA supports the following amendment to the listing of chlorine:

Chlorine materials (Calcium hypochlorite; chlorine dioxide; sodium hypochlorite)—For preharvest use, residual chlorine levels in the water in direct crop contact or as water from cleaning irrigation systems applied to soil must not exceed the maximum residual disinfectant limit under the Safe Drinking Water Act, except that chlorine products may be used in edible sprout production according to EPA label directions.
OTA fully acknowledges that sprouts-regardless of their source-have been identified by the FDA as requiring special food safety protocols because of the potential for pathogen growth during the sprouting process. We also understand from the proposed rule that the NOP consulted the EPA and learned that EPA label directions for sprout seed state that seed should be soaked at 20,000 ppm available chlorine followed by a rinse with potable water. Accordingly, we support the proposed amendment because it will provide operators with the option to use chlorine at the levels recommended by FDA and EPA when such practices are needed to ensure food safety.

OTA would also like to point out that seed disinfection is a highly variable process, and to the best of our knowledge no single method has yet proven to completely eliminate pathogens. The use of chlorine at 20,000 ppm may or may not achieve adequate food safety, therefore OTA recognizes its use as a practice that is most effective when used in combination with other preventative practices. The key is to have a plan that identifies the risks and describes the practices and materials that will be used to achieve food safety followed by testing methods that will validate their effectiveness. In the case of sprouts, post-production testing of sprouts or irrigation water would be used to validate the effectiveness of seed disinfection. OTA believes the most useful information to collect or research would be on the requirements for validation of alternative seed treatments that would assure the safety of sprouts. In other words, what are the criteria for evaluating and accepting alternatives?

OTA acknowledges that food safety is an important issue for the entire food industry and we view food safety safeguards as imperative. U.S. organic producers and processors must comply with all U.S. food safety and other food regulations as well as meet the exacting standards of the NOP regulations. This includes recognizing the importance that sanitation plays in the safety of all foods and allowing for sanitizers such as chlorine materials.

Lignin Sulfonate on § 205.601(j)(4)

OTA supports the proposal to change the annotation on lignin sulfonate at § 205.601(j)(4) to read:

Lignin sulfonate - chelating agent, dust suppressant.

As noted in the proposed rule, during the sunset review for lignin sulfonate, the NOSB noted that including ‘‘floatation agent’’ as an allowable use under the first listing is incorrect since the substance 1 205.601: Synthetic substances allowed for use in organic crop production is not used as a floatation agent for plant or soil amendments. Furthermore, the second listing of lignin sulfonate allows for its use as a floating agent in postharvest handling. OTA recognizes the proposed amendment to be a technical correction only. The proposed rule should not impact producers currently using lignin sulfonate in compliance with the NOP regulations.

Streptomycin on § 205.601(i)(11)

OTA is concerned about the proposed expiration date placed on the use of Streptomycin in organic pear and apple production. The proposed annotation would allow for its use until October 21, 2014. If the proposed rule is not adopted by the NOP, streptomycin would fall back into its normal Sunset cycle and be allowed until October 21, 2017.

OTA is committed to supporting research and efforts to finding alternative materials and methods for controlling fire blight without the use of antibiotics. The National Organic Standards Board (NOSB) proposed a time-limited extension for streptomycin to allow for the continued use of the material while encouraging the industry to increase its efforts to research and develop commercially viable alternatives. They also included a deadline of 2014 to convey the urgency of consumer and public interest groups’ advocacy of eliminating the use of streptomycin in organic tree fruit production. However, based on the information we have received from both our member growers as well as researchers, we believe that the time needed to address the use of streptomycin in organic tree fruit production is much longer than 2014.

Progress is being made on alternative controls for fire blight in organic systems. There are materials registered, but published research (see Sundin et al., 2009) clearly states that results to date have not shown efficacy of alternatives to be similar to that of streptomycin. Researchers around the world are working on biological control and have been for over 20 years. Unfortunately, to date they have not been very successful. According to a recently funded USDA-OREI project in Oregon, Washington, and California, effective biological fire blight control without antibiotics will not be available until 2016. A switch to “resistant” varieties will take a much longer time, likely a decade, and such varieties must be proven acceptable to consumers or they will not be viable choices.

Given the lack of commercially available effective alternatives and the essential role Streptomycin currently plays in the successful production of organic pears and apples (used infrequently, but essential when disease models indicate high risk of infection), OTA is extremely concerned that the 2014 expiration date is premature and the loss of use of streptomycin will have significant impact on the organic sector. The sunset process is designed for exactly this situation, where there is a strong desire to remove a material but suitable alternatives are not yet available. Work is proceeding to develop alternatives, but we cannot guarantee the outcome of research on biological systems, and fixed expiration date as proposed is thus inappropriate for this situation.

Instead, OTA believes it is more appropriate to leave streptomycin in the originally scheduled sunset process and revisit it in five years when much better data and experience have been gained about fire blight control without antibiotics.

Yeast on 205.605(a) 2

OTA supports the following proposed amendment to the annotation on yeast:

Yeast (Autolysate; Bakers; Brewers; Nutritional; Smoked)—When used as food or a fermentation agent, yeast must be organic if its end use is for human consumption; nonorganic yeast may be used when equivalent organic yeast is not commercially available. Growth on petrochemical substrate and sulfite waste liquor is prohibited. For smoked yeast, Nonsynthetic smoke flavoring process must be documented.
We support the proposed rule for the following reasons:
  • Organic yeast is currently available in the marketplace;
  • It promotes the production of organic yeast resulting in increased organic acreage;
  • It recognizes the ability to label certain kinds of yeast as “organic” according to the 95/5composition standard without categorically classifying all microorganisms as agricultural;
  • It recognizes the difference in composition requirements between products intended for human consumption and products intended for livestock consumption; and
  • It’s consistent with the NOP’s Guidance on the Certification of Organic Yeast and Processed Agricultural Products (NOP 5014, effective March 2, 2010) – Attachment 1
The decision to assign commercial availability to yeast using an annotation addresses a larger issue that the organic sector has been struggling with for over seven years. For years the NOSB and the organic sector as a whole has disagreed on whether yeast should be classified as agricultural. While OTA cannot point to yeast as being “agricultural” in a traditional farm sense, we can say yeast are living organisms and their production relies primarily on agricultural material (greater than 95% at formulation). Yeast can be produced in such a way as to meet the NOP standards for a processed agricultural product, and in fact organic yeast is available in many forms intended for human consumption. We recognize that yeast production has definite agricultural and environmental implications and we feel that these should and can be addressed by applying organic principles to yeast used in organic food. We also recognize that the EU has expressly recognized yeast in food and feed as eligible for organic production, and Article 20 of the new EU Council Regulation No. 834/2007 provides general rules for the production of organic yeast.

For these reasons, we find it appropriate to retain yeast on § 205.605(a) and assign commercial availability if its end use is for human consumption. We support making a distinction between human and livestock consumption requirements for the following reasons:

  • Yeast is not universally recognized as agricultural feed. It’s allowed under the NOP regulations at § 205.237(a) as a nonsynthetic feed supplement;

  • The provisions of § 205.237(a) do not provide for commercial availability as do the human food standards;

  • Yeast is not commercially available in the quantity, quality or form needed by the food and feed industry at this time. To require organic in either sector without a commercial availability clause would cause undo hardship on the livestock sector.
Finally, the NOP standards include provisions to guarantee that in organic processed foods even minor ingredients, such as yeast, will have “organic preference” over conventional ingredients. Under § 205.301(b), a product labeled as “organic,” in which at least 95 percent of the ingredients are organic, must also use organic ingredients in the remaining 5 percent to the extent that they are commercially available. There are additional provisions, in § 205.301(f)(6) and (7), requiring products labeled as “organic” to use organic ingredients whenever they are available. This is to ensure the maximum use of organic ingredients and thus stimulate demand for novel organic ingredients, so that the organic trade will develop them.

Over the past seven years, while the NOSB and the organic sector have debated extensively over how organic yeast should be classified, certified operators have not been required to source organic yeast. This proposed amendment to the yeast annotation will give “organic preference” to yeast and thus adopt a reasonable solution to a longstanding situation.

Colors on § 205.6063

OTA supports the following proposed amendment to the annotation on colors provided the NOP clarify that synthetics on the National List at § 205.605(b) may be used as solvents, carriers and preservatives:

Colors derived from agricultural products—Must not be produced using synthetic solvents and carrier systems or any artificial preservative.
The Secretary has requested information about the use of carbon dioxide, a synthetic on the National List at 205.605(b)4, which may be used in a liquid state (supercritical carbon dioxide) to extract colors. Based on conversations with color manufactures, super critical CO2 extraction is limited primarily to paprika (oil-soluble orange). We were informed of one or two Indian suppliers that offer this service for turmeric (oil-soluble yellow). Super critical CO2 extraction is expensive, far more so than solvent extraction. Thus, many companies do not offer any natural colorants resultant from super critical CO2 extraction. Instead, for NOP compliant colors they would use solvents such as ethyl alcohol. In general, cost considerations limit super critical CO2 extraction to those oil-soluble colors where solvent extraction is required.

OTA is concerned about the nature of this request and the potential implications. We wish to express our support for the allowance of carbon dioxide should it be the appropriate means of extraction and request that the NOP clarify in the preamble and further in guidance that synthetic solvents, carrier systems and preservatives on the National List at § 205.605(b) may be allowed in the production of NOP compliant colors. This is an important and reasonable clarification to make since they are allowed in the production of organic colors. Examples of National List solvents, carriers and stabilizers that could be used during the production of colors include ascorbic acid, carbon dioxide, glycerin, silicon dioxide and tocopherols. In order to encourage the production of organic colors, color manufacturers should be able to formulate according to the allowances and restrictions for organic products while they continue to secure a source of organic agricultural raw material by which to derive their colors from.

With the above clarification, the proposed amendment will align the colors allowed in organic products with the colors that were reviewed by the NOSB, AND help to encourage the production of organic colors.

Finally, the NOSB did not review colors extracted with synthetic solvents and they were not presented with colors that relied on synthetic carriers or artificial preservatives, therefore OTA finds it appropriate to consider such forms outside the intent of the current listing, unless the solvents, carriers and preservatives are allowed on the National List. However, OTA also calls to attention the fact that since colors were added to § 205.606 in June of 2007, approval and use has not been limited to colors produced without the use of synthetic solvents, carriers and artificial preservatives. As a result, it’s unknown at this time exactly how many colors currently in use will comply with the proposed annotation and what impact this ruling may have on organic products currently in the marketplace.

To the best of our knowledge OTA members are using or will be able to source agricultural colors that comply with the proposed amendment. We don’t believe that supply is an issue. Rather we believe the issue is whether the supply of compliant colors will match up with the specifications of the products currently being made and sold as organic. It's very likely that in some cases certified operators will need to seek out new suppliers and/or reformulate products. In consideration of the time that may be needed to bring products into compliance, OTA respectfully requests that upon issuance of the final rule, the NOP provide a compliance date of one year from the effective date of the amended listing.

Hops on § 205.606

OTA supports the following proposed amendment to the annotation on hops:

Hops (Humulus lupulus) until January 1, 2013.
The NOSB decision to recommend the removal of hops from § 205.606 was done in response to a fully vetted public process. The NOSB received strong support for the removal of hops from the National List along with supporting information about the quality, quantity and forms of organic hops currently available. Additionally, the NOSB proposed a deadline for the allowance of non-organic hops that allowed brewers two growing seasons to secure organic hops through forward contracting. They also provided brewers with time to petition to the National List specific hop cultivars and forms of cultivars that are inadequately available.

OTA recognizes that the production of organic hops will need to increase significantly to be able to consistently meet the growing demands of the organic brewing industry. Although still small, organic beer has grown into a lucrative niche, riding on the tails of the craft beer movement. The category clocked in compound annual growth of 28% from 2000 to 2009, and grew another 12% in 2010 to $46 million in consumer sales 5.

According to the OTA Organic Industry Survey, some brewers expressed concern that the requirement to use organically grown hops in all certified organic beer may put supply chain strains on new entrants. While OTA is sensitive to the challenges the organic beer industry will undergo, we are also encouraged by the significant advances that are taking place both in terms of research and production.

In 2011, the industry total of organic hop acreage was 308, up from 127 acres in 2010. According to the December 2011 American Organic Hop Grower Association (AOHGA) Organic Hop Market Report, 70,700 lbs. of organic hops were produced by AOHGA growers. However, as of November 17th, 2011, the total pounds of organic hops unsold in inventory was 39,704 lbs. The projected number of organic hop acres for 2012 is 362 acres.

OTA is optimistic about the future of organic hops and believes the proposed rule will chart a course that will facilitate the growth of the organic hop market and assure consumers that organic hops are used in beer.

High-methoxy Pectin on § 205.606

OTA supports the following proposed amendment to the annotation on high-methoxy pectin:

Pectin (non-amidated forms only).

The result of this proposed rule would list all non-amidated (Nonsynthetic) forms of pectin on §205.605 of the National List and prohibit all amidated (synthetic) forms. Based on feedback from OTA membership, non-amidated forms of pectin adequately fulfill the needs and uses of pectin in organic processing.

Again, on behalf of our members across the supply chain and the country, OTA thanks NOP for the opportunity to comment on the proposed rule for Sunset 2012 materials and for carefully consideringour comments.

Respectfully submitted,

Gwendolyn Wyard
Associate Director of Organic Standards and Industry Outreach
Organic Trade Association

cc: Laura Batcha
Executive Vice President
Organic Trade Association

Attachment: NOP’s

Guidance on the Certification of Organic Yeast and Processed Agricultural Products (NOP 5014, effective March 2, 2010)

United States Department of Agriculture 1400 Independence Avenue SW. NOP 5014
Agricultural Marketing Service Room 2646-South Building Effective Date: July 22, 2011
National Organic Program Washington, DC 20250 Page 1 of 2
Original Issue Date: 03/02/10 Authorized Distribution: Public
File Name: NOP 5014 Certification of Organic Yeast Rev01 07 22 11

Certification of Organic Yeast

1. Purpose
This guidance provides clarification on the eligibility of yeast to be certified as organic under the National Organic Program (NOP) regulations.

2. Scope
This guidance applies to National Organic Program (NOP) certifying agents and all certified and exempt organic producers.

3. Background
There has been considerable discussion regarding the eligibility of yeast to be certified as organic under the National Organic Program (NOP) regulations. § 205.605(a) of NOP regulations includes yeast as a natural, nonagricultural substance allowed as an ingredient in or on processed products labeled as “organic” or “made with organic.”

Clarifying the definition of “nonagricultural” or other actions, such as removing a substance from the National List, would require action by the National Organic Standards Board (NOSB). Until such actions occur, NOP finds it necessary to clarify that yeast may be labeled as organic and used in processed organic food products.

4. Policy

4.1 General.

Organic handling requirements (7 CFR § 205.270) allow the use of nonagricultural substances listed in § 205.605, such as yeast, to be used in or on a processed agricultural product that is represented as “organic” if the agricultural product contains at least 95 percent organically produced raw or processed agricultural products. The remaining 5 percent can be a nonagricultural substance such as those enumerated in § 205.605; this includes yeast. Therefore, for example, if yeast is added to a certified
organic agricultural product such as wheat flour and processed according to § 205.270, the resulting product can be certified and labeled “organic.”

Certification of processed agricultural products which are listed as nonagricultural on § 205.605(a) is not without precedence. For example, NOP previously determined that natural flavors, though they are listed as allowable nonagricultural products in organic production, can be certified organic if processed in compliance with NOP regulations. The status of yeast has been of particular interest to livestock producers who feed yeast to livestock as a non-agricultural, non-synthetic feed supplement. Yeast is available for use in livestock feed in either certified organic form or as an allowed non-organic input
specified on the National List.

4.2 Yeast.
A certified organic operation may sell, label, or represent yeast as “organic” when produced in compliance with an approved organic systems plan. Yeast products produced from certified organic inputs such as certified organic flour and certified organic corn steep liquor may be certified as organic.

For yeast to be certified as organic, yeast used as a starter culture does not have to be certified as organic. However, if certified organic yeast is used as the starter culture, subsequently produced yeast is eligible for certification as “100 percent organic” as long as all other production and handling requirements are met.

4.3 Yeast used in Livestock Feed.
Certified organic livestock operations may feed non-organic yeast to their livestock as a nonsynthetic feed supplement per § 205.237(a).

5. References

NOP Regulations (as amended to date)

7 CFR § 205.237 Livestock feed.
(a) The producer of an organic livestock operation must provide livestock with…

7 CFR § 205.270 Organic handling requirements.

7 CFR § 205.301 Product composition.

(a) Products sold, labeled, or represented as “100 percent organic.”

7 CFR § 205.605 Nonagricultural (nonorganic) substances allowed as ingredients in or on processed products labeled as “organic” or “made with organic (specified ingredients or food group(s)).”

(a) Nonsynthetics allowed…

Approved on July 22, 2011


1 205.601: Synthetic substances allowed for use in organic crop production.

2 § 205.605(a) Nonsynthetic, nonagricultural substances allowed as ingredients in or on processed products labeled as ‘‘organic’’ or ‘‘made with organic (specified ingredients or food group(s))’’

3 § 205.606 Nonorganically produced agricultural products allowed as ingredients in or on processed products labeled as ‘‘organic’’.

4 The Secretary specifically seeks comments on this proposed amendment with regard to the extent of use of carbon dioxide, a synthetic solvent that is on the National List at § 205.605(b), which may be used in a liquid state (supercritical carbon dioxide) to extract colors.

5 OTA 2011 Organic Industry Survey

2014 Annual Fund

Research and Promotion 2012