General Comments - Organic Trade Association
Organic Trade Association
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General Comments


of the

7 CFR Part 205 [Docket Number: TMD-00-02-PR2]
RIN: 0581-AA40

National Organic Program; Proposed Rule

Keith Jones, Program Manager
National Organic Program
USDA-AMS-TMP-NOP, Room 2945-So.
Ag. Stop 0275
P.O. Box 96456
Washington, DC 20090-6456

1. The Organic Trade Association applauds NOP for its thoughtfulness in the new Proposed Rule.

Following are some of the points for which OTA believes the NOP deserves special commendation:

The record-keeping provisions in this proposed rule accurately reflect the practices and needs of the industry. OTA thanks the NOP for appreciating that "different types of certified production and handling operations will by the very nature of their business, be required to maintain different records to establish their compliance with the Act and regulations" (pp. 13520 and 21). OTA agrees on the emphasis for non-certified operations of the record-keeping provisions of Section 205.101(c)(2), the provisions for protection against commingling and contact of organic substances with prohibited substances in Section 205.272, and the applicable labeling regulations. OTA also likes the sense conveyed in the phrase, "the opportunity to decide for itself what records are necessary to demonstrate [the business’s] compliance" (p. 13527).

OTA applauds statements such as the following from 205.100: "A portion of a production or handling operation can be certified." This is an example of the kind of attention to the needs and practices of the industry that OTA has been hoping for. OTA is also encouraged to see that the USDA has included the concepts of "commercial availability" and "organic integrity" in the proposed rule.

OTA endorses the USDA position, as stated in 205.203(c), that "The producer must manage animal and plant waste materials to maintain or improve soil organic matter content in a manner that does not contribute to contamination of crops, soil, or water by plant nutrients, pathogenic organisms, heavy metals, or residues of prohibited substances."

Under 205.238(a)(5), Livestock, OTA recognizes that USDA is breaking new ground by accepting the principle behind the provision "Animals in an organic livestock operation must be maintained under conditions which provide for exercise, freedom of movement, and reduction of stress appropriate to the species." This inclusion of an animal welfare standard with emphasis on reducing pain and stress is a most welcome step.

OTA recognizes with pleasure that USDA has demonstrated its understanding of some of the ecological principles behind organic production with its call for mandatory crop rotation in section 205.205.

OTA thanks USDA for including in its provisions for labeling the new category of "100% organic," and hopes that these proposed revisions for the regulations for that category, along with the "organic" and "made with organic" categories, will be considered as useful refinements.

OTA accepts with pleasure the provision in 306(c), that if a product is labeled to meet foreign labeling requirements, those packaged products are for export only. This is especially critical if the standards of the importing country are lower than those in the US, and the product has been produced and/or handled to meet those standards.

OTA appreciates that in 205.404(b)(3) NOP revised the requirements for certificates to provide that a certificate of organic operation specifies the categories of that operation, including crops, livestock, or processed products. NOP will note that OTA’s comments include a proposal to further define organic operations on the certificate.

OTA notes that NOP recognizes the importance of the principles of equivalency in establishing reciprocity with other nations: "Upon implementation of this program, the Administrator will give consideration to accepting as equivalent technical regulations of other countries, even if these regulations differ from our own, provided such regulations fulfill the objectives of this proposed program." OTA also hopes that NOP, where appropriate, accepts as equivalent the regulations of private international accreditors.

Regarding State provisions, OTA thanks the NOP for including in the Preamble the statements that a State government may not prevent the marketing or sale in the State of organic product produced in another State to this program’s national organic standard, and that if a State organic certification program proposes a requirement or procedure that will have a negative effect or discriminate against private certifying agents operating in the State, the Secretary will not approve the requirement or procedure.

Finally, OTA commends NOP for reflecting the NOSB recommendations in the National List. OTA appreciates that USDA has appropriately honored the authority of the NOSB under OFPA.

2. Post practice standards and program manuals in the Federal Register.

OTA believes that in order for the purpose of practice standards and program manuals to be realized effectively, the organic community should have the opportunity to comment on their content. All proposed practice standards and program manuals should therefore be developed in consultation with the NOSB and posted in the Federal Register, with adequate time given to review their contents for comment.

3. Define genetically engineered/modified organisms and their products and derivatives as prohibited, synthetic materials.

a) While it is necessary for NOP to define the methods used to produce GMOs as excluded from organic production, such a definition is not sufficient. OTA emphatically recommends that excluded methods be defined as "prohibited" in organic production. OTA feels it is important to recognize in the definition that excluded methods also fall under the Proposed Rule’s definition of "synthetic." OTA recognizes that NOP considers this unnecessary, but NOP has not given any substantive reason for this position, or shown what harm such a definition would cause. If breaking a chemical bond produces a synthetic material, then using excluded methods produces synthetic materials.

b) OTA accepts the decision-tree structure of the Organic Materials Review Institute for the purposes of determining whether a substance contains GMOs under this Rule. Due to the rapid expansion of GMOs in agriculture, the situation in 2000 is more complex than in 1997, and OMRI’s approach is clearly workable.

c) Regarding the drift of GMOs and their derivatives into areas of organic production:
Section 205.671 should be amended:

"(b) If the investigation of a certified operation determines that the presence of residues of prohibited materials, in excess of the estimated national mean or unavoidable residual environmental contamination, is due to drift from a neighboring operation, the applicator and manufacturer of the prohibited substance shall be liable for damages incurred by the organic producer."

Rationale: Section 205.671 provides no protection of organic producers from chemical or genetic trespass. Liability for damages is not addressed. If a certified organic producer is meeting all requirements of the Act, yet the operation is contaminated by chemical or genetic drift, and the products cannot be sold as "organic," as mandated by OFPA section 6511(c)(2), organic producers should not be penalized. The manufacturers and applicators of prohibited and excluded materials must be held liable for losses suffered by organic producers when the prohibited and excluded materials they sell or apply contaminate neighboring organic crops and/or livestock. One appropriate way to do this would be to include insurance against drift under USDA’s crop insurance program, with the insurance covering the value lost if a crop had to be sold as conventional rather than organic.

d) Additionally, OTA approves of the inclusion in 205.204(b) of the provision that the producer of an organic operation must not use seeds or planting stock produced with excluded methods.

e) OTA asserts that meeting the requirement that non-organic ingredients from "excluded methods" not be allowed in products labeled "made with organic ingredients" can only be fully implemented once the FDA requires mandatory positive labeling of all foods containing GMOs. This is also necessary for livestock feed, animal drugs, pesticides, plant foods, and any other place where GMOs are likely to enter the organic food and farming system.

To comply with the rule as proposed, processors and handlers would benefit from consistent positive labeling of GEO/GMO non-organic ingredients. In the absence of such required labeling, certifiers will need to develop a system to ensure that non-organic ingredients in a processed product that makes a "made with" claim are non-GMO. The lack of mandatory labeling of GMOs, combined with a requirement that non-organic ingredients in "made with" products must be verified as non-GMO, places undue, and unprecedented, burdens on handlers and certifying agents.

On page 13535 of the Proposed Rule, the NOP states:

"We anticipate that this system of carefully reviewed and documented organic plans which establishes documented procedures demonstrating good faith efforts to diligently pursue and maintain the integrity of ingredients produced without the use of excluded methods could satisfy the requirements in this regulation."

Until and unless there is mandatory labeling of GMOs and their derivatives, the organic industry has no choice but to rely on "good-faith efforts" to ensure that the process of organic production does not include the intentional introduction of GMOs or their derivatives into the organic food chain.

The following sample compliance letter for non-GMO sourcing is provided as an example of what constitutes a good faith effort to establish the non-GMO origin of products and ingredients.

Re: Genetically modified organisms
Dear Vendor,
In order to maintain our organic certification, we are required to obtain information regarding genetically modified organisms (GMOs) for all of our ingredients.
Please supply the following information:
Name of company__________________________________________________________
Name of product(s)_________________________________________________________
Name of company representative completing this form (please print)_________________

Please check whichever statement applies:
___I am a certified organic farmer and therefore comply with all relevant regulations.
___To the best of my knowledge, this product does not contain GMOs or their derivatives.
___This product was derived from a genetically modified source material, but should not contain modified DNA or the proteins derived from genetically modified DNA.
___This product may have been derived from a genetically modified source material but should not contain modified DNA and/or the proteins derived from genetically modified DNA. Its exact status cannot be determined due to intermixing of genetically modified and non-genetically modified varieties at source.
___This product does not contain genetically modified material and was not derived from a genetically modified source but was produced using processing aids derived from a genetically modified material (e.g., produced using an enzyme derived from a genetically modified organism).
___This product does contain GMOs and/or the proteins derived from genetically modified DNA.
Thank you very much.

4. Reconsider the Pesticide Data Program and the Estimated National Mean.

OTA is uncertain that the Pesticide Data Program (PDP) is appropriate for consideration regarding organic production. The principal points OTA urges NOP to consider are:

1) OTA does not approve of using the method of the Estimated National Mean (ENM) for the reason that it was developed to cover farmers who use pesticides and therefore is inadequate to cover the major pesticide problem of organic growers—drift.

2) If there is no ENM figure for a particular pesticide-crop pair, there must not be a "zero tolerance" for that pesticide. There has to be some alternate method of approaching the problem, which recognizes the reality of drift but sets limits as to the extent of contamination that will result in the suspension of a product’s certification.

3) OTA supports the solution of the Organic Materials Review Institute, while maintaining that major problems in implementation of the PDP/ENM approach remain.

Section 205.671(a) prohibits the sale of an agricultural product as organic if pesticide residues exceed the "estimated national mean of detected pesticide residues" from the PDP or if residues exceed the "unavoidable residual environmental contamination, as determined by the Administrator." The purpose of this section should be to establish a workable, consistent pesticide residue standard for organic foods as mandated by the OFPA. Instead of following the NOSB Recommendation on Residue Testing, the American Organic Standards, current organic industry residue standards, and the advice of the Senate Agricultural Committee (Report 101-357, July 6, 1990), USDA has proposed a double standard that is inconsistent and very difficult to understand.

Estimated National Mean from the PDP: This is very problematic as a standard because organic producers and handlers do not know what the standard is. The PDP does not have data for all crop/pesticide combinations. What is the residue standard for crops without an "estimated national mean?" Will the standard change every year as new data are compiled by the PDP? Will the cost of residue testing increase as a result of using the "estimated national mean?" In some regions of the country, the "unavoidable residual environmental contamination" level for a pesticide may be higher than the "estimated national mean"—this could put some organic farmers out of business due to circumstances out of their control.

5. Define unavoidable residual environmental contamination (UREC).

Unavoidable residual environmental contamination (UREC) is problematic as a standard because it is undefined. We cannot comply with an undefined standard. OTA’s questions include: How will the Administrator determine UREC levels? Will UREC levels be published? Will UREC levels be different for different locations?

Section 205.671(a) prohibits the sale of an agricultural product as organic if pesticide residues exceed the "estimated national mean of detected pesticide residues" from USDA’s Pesticide Data Program or if residues exceed the "unavoidable residual environmental contamination, as determined by the Administrator." This Section fails to establish a workable, consistent pesticide residue standard for organic foods and should changed to be consistent with the NOSB Recommendation on Residue Testing and the American Organic Standards. This Section must establish the maximum pesticide residue levels for organic foods as the FDA action level or 5 percent of the EPA tolerance.

OTA believes that the proposal to have UREC levels determined by the Administrator is very impractical and potentially very expensive to implement. It is preposterous to suppose that there will be a UREC determined for every organic farm in the United States. This issue needs to be handled as a practice standard or program manual issue, with appropriate NOSB review and notification in the Federal Register. And if the UREC is not determined scientifically, there is a high likelihood that this proposal will expose the USDA to unnecessary litigation in situations where the UREC is established at a lower level on one organic farm than on a neighboring organic farm.

OTA urges NOP to follow the NOSB Recommendation, the American Organic Standards, and current organic industry practice. As a residue standard for organic foods, "the FDA action level or 5 percent of the EPA tolerance" has a proven track record, is practical, is consistent, is inexpensive to use, and provides confidence to consumers.

6. Use the AOS in considering further revisions.

When considering alternatives to various provisions in the Proposed Rule, OTA respectfully requests NOP to refer to the American Organic Standards, which is an up-to-date compilation and codification of US organic standards and certification procedures, for guidance in areas where there is need for additional clarity. Any further detail in practice standards or program manuals should be consistent with the AOS.

7. Support small farmers.

OTA supports making this Rule sustainable for small farmers, and urges NOP to consider the effect on small farmers in making each of its decisions. There are several areas in OTA’s comments which are based on this principle, including implementation of a new herd dairy clause, allowance of "transitional" labeling, and changes to the compost definition and practice standard, which need to be addressed to support family farmers and the transition of small producers to organic. OTA also supports creation of a simple, cost-effective registration program for operations that are exempt and/or excluded from having to be certified.

OTA seeks assurance from NOP that farmers who are currently using substances allowed by their certifying agent that may not be acceptable under the Final Rule will not lose their certification status, nor will have to undergo 36-month transition, as long as these farmers stop using such substances by the date of implementation of the Final Rule.

The creation of a national cost share program for transitional and certified organic producers should be a priority consideration by USDA. Such a program would demonstrate that USDA had a true commitment to keeping small farmers on the land and providing these farmers with new market opportunities.

8. Support smaller, member-based certifiers.

OTA supports making this Rule as friendly as possible to smaller, member-based certifiers. OTA has included in these comments an extensive treatment of solutions to the problems of conflict of interest and believes that this reasonable solution allows current member-based certification agencies to continue their activities with minimal disruption.

9. Expedite the review of materials for the National List.

Approximately 200 materials need to be reviewed to keep the organic industry on track. This is consistent with the Proposed Rule’s preamble statements: "expedited review of inert and other non-active substances [and] materials review can be anticipated as the NOSB’s primary activity during NOP implementation". This is a greater volume of work on materials than the NOSB has faced in the past, and we respectfully request that NOP implement a schedule of meetings sufficient to cover the necessary reviews. The organic industry is prepared to work collaboratively with NOP and NOSB to prioritize those substances that are essential to organic production and handling.

10. Use organic ingredients in the "organic" category whenever they are commercially available.

NOP will note that OTA’s comments include a requirement to use organic ingredients whenever commercially available in the "organic" labeling category. OTA has also included a workable process for the determination of whether or not a product is commercially available. OTA’s support of the use of the categories "made with organic" and "organic" is in no way meant to condone the use of non-organic forms of a product for the "organic" category when an organic form is available. Rather, it is meant to make the "organic" category as organic as possible.

12. NRCS 317 is an inadequate guide for organic compost operations.

OTA believes that NRCS 317 is inappropriate for organic production. Not only are key terms, such as "facility," undefined, the standard does not seem to take into account small, on-farm operations. Please refer to the comment submitted by Elaine R. Ingham (Soil Foodweb Inc., 1128 NE 2nd St., Suite 120, Corvallis, OR 97330) for a fuller discussion of issues surrounding the NRCS standard.

13. NOP, AOS, and NOSB recommendations are sufficient to allow the use of raw manure.

OTA notes that the organic industry is the only sector of agriculture with strict existing guidelines on the use of raw manure and the requirements of current certification standards have been effective in managing the use of raw manure. The Organic Foods Production Act (OFPA) embodied the practices of the organic industry in USC Section 6513 Organic Plan (b) Crop Production Farm Plan (2) Manuring (B) Application of Manure. OTA supports Section 205.203(a)(1) of the Proposed Rule as written because it reflects the intention of OFPA and the recommendation of the NOSB.

It is important to recognize that the use of raw manure is not unique to organic crop production, but common practice in all US agriculture. With the emergence of E. coli O157H7, it is incumbent on the government to conduct adequate research to determine the safety of current agricultural practices. OTA urges USDA to work with the appropriate federal agencies to conduct such research and if necessary develop regulations for the use of raw manure that apply to all types of agricultural systems. The organic industry will comply with all federal regulations governing food safety. 

14. Rework the appeal process.

A fair and effective appeal system is essential to the success and integrity of NOP and to the accreditation process. NOSB recommendations must be reflected in the appeal procedures proposed in the Final Rule. Further, the appeal procedures must be written to avoid conflict of interest, be consistent, timely, and affordable. The proposed language should:

place final decision making authority in the administrative review process in the hands of the Secretary;

require that the NOP appeal be conducted by independent hearing officers who are not responsible for the implementation and administration of the NOP;

ensure an "expedited" appeal process with an opportunity to correct any adverse decision; and

include mandatory procedures for timely written notice of adverse decisions, the reasons for the decision and the appeal rights and procedures.

15. Include basic standards for organic sprout, greenhouse, mushroom, and maple syrup production and apiculture.

The Proposed Rule as offered by USDA has not included basic standards for organic sprout, greenhouse, mushroom, and maple syrup production, or apiculture. These products already have significant market presence, and are being certified by State and private certifying agents. Not including these standards will result in either the disappearance of these products from the marketplace or additional requirements applied by certification agents.

16. OTA seeks clarifications.

OTA also requests clarifications on a number of areas:


Compost. OTA requests a clarification from NOP on NRCS 317. What is the purpose of inserting this standard, meant for determining applicability for an NRSC cost share program, into the Proposed Rule?


Section 205.102(c) requires compliance with numerous other Federal statutes and regulations. Does this provision mean that an operation that violates one of the statutes listed will automatically lose its organic certification status? Does it mean that organic inspectors and certifying agents must verify compliance with other statutes in order to grant organic certification? Does it mean that certifying agents are in violation of Federal statutes if they grant certification to an operation that is not in compliance with all of the statutes listed? Does it mean that inspectors and certifying agents are bound by law to report violations of other statutes to applicable regulatory agencies? Does it mean that regulatory agencies with authority over other statutes will report violations to organic certifying agents? What exactly are the implications of this provision?


Section 205.200 requires both producers and handlers to "maintain or improve the natural resources of the operation, including soil and water quality." While this is an excellent general requirement for producers, is this a reasonable, or even applicable, requirement for all handlers? How will inspectors and certifiers assess compliance with this requirement?


Section 205.501(c)(2) requires accredited certifying agents to provide "reasonable security" to USDA. The amount is unspecified and its affordability is of concern, especially for regional, membership based certification programs. Exactly what is meant by "reasonable security"? OTA requests that a definition of reasonable security and description of the method of determination be developed in consultation with the NOSB and posted in the Federal Register for comment.

106. 205.620

The terminology of section 205.620, "State Programs," confuses "State organic certification programs" and "State organic programs." It is unclear if this section applies only to States that act as certifying agents or if it also covers State organic programs. It is also unclear if States can have additional requirements, and take enforcement actions, without establishing certification programs. In order to clarify, strike the word "certification" from the definition "State organic certification program" in section 205.102 and in sections 205.620, 621 & 622, if this section is intended to cover State organic programs. State certifying agents are adequately defined and considered elsewhere in the proposed rule.

How do sections 205.620, 621 & 622 impact States that have organic programs, but delegate certification to private certifying agents? For example, Minnesota statute section 31.95 states:

"The commissioner shall designate one or more organizations made up of organic food growers, manufacturers, or sellers, to certify organically grown seeds, products, and food."

Section 31.94 states:

"The commissioner shall enforce sections 31.92 to 31.95. The commissioner shall withhold from trade or sale any product sold, labeled, or advertised in violation of sections 31.92 to 31.95.

"The commissioner shall investigate the offering for sale, labeling, or advertising of an article or substance as organically grown, organically processed, or produced in an organic environment if there is reason to believe that action is in violation of sections 31.92 to 31.95.

"The commissioner may adopt rules that clarify organic food standards and marketing practices."

In Minnesota, all certifying agents must be reviewed by the Organic Advisory Task Force and approved by the commissioner. The State has an organic certification cost share program to assist certified organic producers. The State has taken action to investigate and enforce the organic statute against persons making fraudulent organic claims. Do the requirements of section 205.620, 621, & 622 apply to a State such as Minnesota, since it is not established as a State certifying agent?

If a State enacts an organic marketing program, but has no role in certification or enforcement, must the State’s program be reviewed and approved by the Secretary? This is not clear from the proposed text, since it only addresses State certification programs.


Section 205.660 "Compliance," does not address funding for investigation and enforcement. As proposed, certain compliance authorities are to be administered by certifying agents. If certifying agents are enforcing compliance with a Federal law, who should pay for their investigation and enforcement actions? Likewise, if States engage in enforcement actions, should they bear the financial burden with no assistance from the Federal government? If enforcement is needed in a State with no State organic program, and where no private certifier operates, compliance is the responsibility of the USDA. What are the funding mechanisms to be used by the USDA to engage in such enforcement actions? Without addressing these critical issues, it will be difficult to fully implement the program.


OTA would like clarification on what constitutes "reasonable cause to believe" that a product has come into contact with a prohibited substance. OTA supports the provision but is concerned about the potential for abuse if what constitutes "reasonable cause" is left open to a wide range of interpretations.

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