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NOP-Vitamins-Minerals

NOP: Draft Guidance on Evaluating Allowed Ingredients and Sources 08-12-11 - Organic Trade Association
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NOP: Draft Guidance on Evaluating Allowed Ingredients and Sources 08-12-11

 

August 12, 2011

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

RE: National Organic Program; Notice of Draft Guidance NOP 5030: Evaluating Allowed Ingredients and Sources of Vitamins and Minerals for Organic Livestock Feed, Feed Supplements, and Feed Additives. AMS-NOP-11-0002: NOP-11-02

Dear Ms. Strother:

Thank you for the opportunity to comment on NOP Draft Guidance on Evaluating Allowed Ingredients and Sources of Vitamins and Minerals for Organic Livestock Feed, Feed Supplements, and Feed Additives.

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OTA strongly supports the issuance of Draft Guidance on the evaluation of ingredients, vitamins and minerals used in livestock feed. Clarification is long overdue, and guidance is greatly needed to ensure consistent application of the regulations. OTA is concerned, however, that the Draft Guidance as written creates additional confusion and raises more questions than answers.

The following is a summary of our suggestions for improvement:

  • OTA requests that the guidance distinguish between the requirements for agricultural ingredients added to feed directly (appearing on the final livestock feed label) and the requirements for agricultural ingredients added to supplements or additives that are, in turn, added to a complete livestock feed ration.

  • OTA supports the guidance that agricultural ingredients cannot be sourced from slaughter byproducts from poultry or mammalian sources (if being fed to poultry or animals). OTA requests that NOP clarify if the guidance is specific to proteinated mineral sources and mineral sources from bone, as it appears to read in the guidance, or whether NOP is expecting verification of all vitamins and minerals used in livestock feed.

  • OTA supports the guidance that non-synthetic, nonagricultural ingredients including direct-fed microorganisms (“probiotics”), yeast, and enzymes are allowed in organic feed under § 205.237. We’re concerned, however, that the guidance expresses the prohibition on excluded methods for vitamins and minerals approved by FDA and AAFCO (most of which are chemically synthesized and produced by methods that would not incorporate genetic engineering) but does not express the prohibition on excluded methods for non-synthetic substances such as microorganisms and enzymes (many of which are biological in nature and commonly produced using excluded methods).

  • OTA suggests that the clarification in 4.1(b)(6) be changed to specify that a livestock feed sold, labeled or represented as “100% organic” must contain ONLY organically produced and handled agricultural products certified under the NOP regulations. No other feed additives or feed supplements may be added. Language specifying the total composition of the product would be most useful since 100% of the agricultural ingredients in “organic” livestock feed must also be organic.

  • OTA requests further clarification on the use of incidental additives and processing aids. Are they allowed without review if used during the manufacturing of a certified livestock product? Or, are they allowed without review in feed supplements and feed additives that are added to livestock feed?
OTA respectfully submits the following more specific comments on the NOP Draft Guidance:

4.1 Certified Organic Livestock Operations

4.1 (a) & (b)
As clearly stated in the regulations, OTA supports the guidance that certified organic livestock operations must feed organic animals certified organic livestock feed, and all forages, feed ingredients, formulated feed products, feed supplements, and feed additives must be described in the OSP. OTA also supports that all livestock feed, feed supplements, or feed additives sold, labeled, or represented as organic must be organically produced, handled and certified under the NOP regulations.

4.1(b)(1) & (2)
The Draft Guidance states that all agricultural ingredients included in the ingredients list for livestock feed products must be organic. OTA agrees with this statement as it applies to the label or ingredients list of a certified livestock feed product. However, we recognize there is confusion about the requirements for agricultural components in a livestock feed product vs. the requirements for agricultural components that are listed in the ingredient statement of an ingredient, such as a vitamin premix carrier, that is added to the final livestock feed product but does not appear on that livestock feed label.

Under 4.1(b)(2), the guidance states that agricultural ingredients that are added to feed, such as wheat middlings, rice hulls, vegetable oil, or molasses used as carriers or dust suppressants, must be certified organic. This adds to the confusion. OTA agrees that any of the above agricultural ingredients appearing on the final livestock feed label must be organic. However, many of the examples above are used as carriers in vitamin premixes and added indirectly to the final feed product, thus meeting the definition of an incidental additive as specified in 4.1(d).

OTA requests that the guidance distinguish between agricultural ingredients added to feed directly (appearing on the final livestock feed label) and agricultural ingredients added to supplement or additives that are added to livestock feed. The Draft Guidance and the regulation at 205.237(a) refer to “the ingredients list.” We request that NOP clarify which “ingredients list” is being referred to: 1) the ingredient list on the final livestock feed product, or 2) the ingredient list on the feed supplement or feed additive.

Clarification also is needed on the following situations:
  1. The ingredient list on the label of a certified feed product. All agricultural ingredients included in the product must be certified organic. This is generally understood, agreed upon and practiced.

  2. The ingredient list on the label of a vitamin premix that is being added to a certified feed product. The vitamin premix may contain an agricultural carrier such as wheat middlings. The agricultural carrier, however, does not appear on the final livestock feed label. OTA’s understanding is that the wheat middlings do not need to be organic because they do not appear on the label ingredient list for the final livestock feed product. The wheat middlings are considered an indirect additive, and would thus fall under 4.1(d) and not need to be evaluated.1

  3. The ingredient list on the label of a vitamin premix that is blended with organic agricultural feed to create a complete feed ration. In many instances, the producer purchases organic agricultural ingredients along with a vitamin premix and blends the two together to create a complete livestock feed ration. The feed is not sold but fed on-site. The vitamin premix label/ingredient listing is submitted to the certifier for approval. The certifier reviews organic certificates and the ingredient listing for the premix. The premix ingredient listing may include an agricultural carrier such as rice hulls or wheat middlings. A final livestock feed label, however, is never created. If one were to be created, the carriers would not need to appear on the label.

4.1(b)(3) & 4.1(c)
OTA supports the guidance that agricultural ingredients cannot be sourced from slaughter by-products from poultry or mammalian sources (if being fed to poultry or animals), or sourced from products produced by excluded methods. We also agree that proteinated mineral sources (metal proteinates) sourced from slaughter by-products and minerals sourced from bone such as bone charcoal, bone meal
or bone phosphate are considered slaughter by-products, and are also not permitted.

We are concerned however by the general guidance statement that “minerals and vitamins approved by FDA…. or….AAFCO…” cannot be sourced from slaughter by-products. The large majority of the allowed feed additives are synthetic. A relationship between an allowed synthetic vitamin or mineral and the prohibition on feeding mammalian or poultry slaughter by-products to mammals or poultry is
one that is not commonly made. We are concerned that such verification has not been common practice (with the exception of proteinated mineral sources and minerals from bone). OTA requests that NOP clarify whether the guidance is specific to proteinated mineral sources and mineral sources from bone, as the guidance appears to read, or whether NOP is expecting verification of all vitamins
and minerals used in livestock feed.

4.1(b)(4)
OTA supports the guidance that non-synthetic, non-agricultural ingredients including direct-fed microorganisms (“probiotics”), yeast, and enzymes are allowed in organic feed under § 205.237.

We’re concerned, however, that the guidance expresses the prohibition on excluded methods for synthetic vitamins and minerals approved by FDA and AAFCO (most of which are chemically synthesized and produced by methods that would not incorporate genetic engineering) but does not express the prohibition on excluded methods for non-synthetic substances such as microorganisms and enzymes (many of which are biological in nature and commonly produced using excluded methods).

OTA requests that NOP clarify that the prohibition on excluded methods applies to nonsynthetic or agriculturally derived feed ingredients, feed supplements and feed additives such as direct-fed microorganisms (“probiotics”), yeast, and enzymes.

4.1(b)(6)
The Draft Guidance at this section states “livestock feed sold, labeled or represented as “100% organic” must contain not less than 100% organically produced and handled agricultural products certified under the NOP regulations as per § 205.301(e)(1).

The composition for livestock feed falls into two categories: 1) 100% organic; and 2) Organic. A livestock feed product sold, labeled or represented as “Organic” must, in accordance with § 205.237, contain 100% organically produced and handled agricultural products certified under NOP. Synthetic substances allowed under §205.603 and non-synthetic substances not prohibited under §205.604 may be used as feed additives and feed supplements.

OTA suggests that the clarification in 4.1(b)(6) be changed to specify that a livestock feed sold, labeled or represented as “100% organic” must contain ONLY organically produced and handled agricultural products certified under the NOP regulations as per § 205.301(e)(1). No other feed additives or feed supplements may be added. Language specifying the total composition of the product would be most useful since 100% of the agricultural ingredients in “organic” livestock feed must also be organic.

4.1(d)
The Draft Guidance states that incidental additives and processing aids as described in 21 CFR § 501.100 (a)(3) do not require review by certifying agents. OTA requests that NOP consider the following situations and provide further guidance:
  1. A certified handler is manufacturing pelleted livestock feed that will be labeled as “organic.” The certified operator would like to use an anticaking agent that will be present in the final pelleted feed product at insignificant levels and will not have a technical or functional effect. The anticaking agent is exempt from the feed ingredient label. In this situation, does the certifier need to review the processing aid for compliance?

  2. A certified handler is making a certified feed ration comprised of organic agricultural ingredients and a vitamin premix containing synthetic substances allowed under § 205.603. However, the vitamin premix also contains a preservative, ethoxyquin, and a non-organic agricultural carrier. Both the preservative and the carrier will not have a technical or functional effect on the final feed product and they will not appear on the final livestock feed product label. Are both allowed?We request guidance clarifying whether incidental additives and processing aids are allowed without review if used during the manufacturing of a certified livestock product or if they are allowed without review in feed supplements and feed additives that are added to livestock feed.

Conclusion

Again, OTA thanks NOP for issuing draft guidance in an area where material review decisions have been made inconsistently for many years. Documented discussions on livestock feed ingredient issues dates back to at least 2002, at which time an NOSB committee recommendation titled “Livestock Feed Ingredient Issues” was drafted to clarify the use of incidentals, carriers, non-incidental preservatives, probiotics and enzymes. Several of the same issues addressed in the 2002 committee recommendation, but never finalized, are now addressed in the NOP Draft Guidance. The efforts made on this guidance will be very beneficial in furthering consistent material review that is essential to market stability and the overall confidence and growth of the organic sector.

On behalf of our members across the supply chain and the country, OTA thanks NOP for the opportunity to comment and for carefully considering our 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


1 4.1(d) Incidental additives and processing aids as described in 21 CFR § 501.100 (a)(3) do not require review by certifying agents. They are considered incidental because: They are present in feed at insignificant levels and do not have any technical or functional effect; 2. They are exempt from feed ingredient labeling and do not appear on the ingredients label for the final formulated feed; 3. They are present by reason of having been incorporated into the feed as an ingredient of another food, in which the substance did have a functional or technical effect, but no longer has a technical effect in a final product; and/or 4. They were used as processing aids and have been removed. from bone, as the guidance appears to read, or whether NOP is expecting verification of all vitamins and minerals used in livestock feed.

 
 
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