Organic Watch’s 16 Issues of Major Concern
Introduction.
The following material was created as an aid to organizations and individuals who are preparing comments concerning the United States Department of Agriculture (“USDA”), Agricultural Marketing Service’s, “National Organic Program; Proposed Rule” found at 62 Federal Register 65850 (December 16, 1997). Organic Watch encourages duplication and wide distribution of this material and no prior permission for such activity is required.
All comments concerning the proposed rule should be submitted to: Docket Number TMD-94-00-2, Eileen S. Stommes, Deputy Administrator, USDA-AMS-TM-NOP, Room 4007-So., Ag Stop 0275, P.O. Box 96456, Washington, DC 20090-6456, and, if possible, electronically at http://www.ams.usda.gov/nop. The current deadline for comment submission is April 30, 1998. Please note that all comments submitted to the docket should be labeled by “comment topic heading” and include the specific section number and/or Federal Register page citation where a particular subject is discussed.
Procedural Considerations.
Issue Number 1. Commenters Should Seek Withdrawal of the Proposed Rule and Preparation of a New Rule Which Comports with the NOSB Recommendations. (Comment Topic Heading: General).
Request that the USDA withdraw the current proposed rule for the establishment of a national organic program with the intent of having the agency prepare a revised proposed rule which comports with the requirements of the Organic Foods Production Act (“OFPA”), 7 U.S.C. § 6501, et seq., and accurately reflects the recommendations of the National Organic Standards Board (“NOSB”). See, Appendix I, “USDA’s National Organic Program: Procedural Issues.” See also, Appendix II, “A Brief Analysis of Past Federal Agency Action Withdrawing Proposed Rules.”
Issue Number 2. Commenters Should Request that the Rule Be Reframed Strictly as a Process Standard. (Comment Topic Heading: General).
The NOSB focus, and that of other organic standards, has been to establish acceptable processes by which organic foods can be grown, handled, marketed, etc. In this regard, the NOSB recommendations were designed to create a national system outlining how to farm, process and handle organically. However, the USDA has attempted to alter this approach to the organic rule through the introduction of “performance” standards. In describing these standards USDA states, “Performance standards are generally written in terms of the results expected.” 62 Federal Register 65869 (emphasis added). As a result, USDA has attempted to change the overarching philosophy of the rule from one of “processes” (process standards) to one of “end results” (performance standards or product standards). This philosophical shift informs the entire proposed rule and provides USDA with its basis for creating a number of large, vague exemptions from the organic processes recommended by the NOSB.
In addition, the USDA has made numerous changes in definitions that serve as the basis of the proposed national organic program. USDA has altered a number of definitions (e.g., organic, unavoidable residual environmental contamination) and added new, previously undiscussed definitions (e.g., non-active synthetic, cytotoxic mode of action). These definitional changes inform USDA’s attempt to change the National Organic Program (“NOP”) into a performance-based program allowing for new exemptions from required organic processes and standards. See generally, § 205.1 & 205.2; 62 Federal Register 65865-65867.
Major NOSB Recommendations Reversed or Altered in the USDA’s Proposed Rule.
Organic Watch believes that the successful implementation of the Organic Foods Production Act (“OFPA”) is dependent upon maintaining the statutory authority and independent integrity of the National Organic Standards Board (“NOSB”). It is therefore essential that the USDA’s proposed rule comports with the original NOSB recommendations. The following list of issues is based upon USDA proposals that alter consensus definitions, processes, and recommendations established by the NOSB. In many instances, Organic Watch believes that the USDA’s action may be violative of the OFPA. See, Appendix III, “Brief Legal Analysis of the NOSB.”
Issue Number 3. Commenters Should Request that the Statutory Authority of the NOSB Be Maintained. (Comment Topic Heading: General/National List).
The NOSB has two distinct roles: (1) to provide the Secretary of Agriculture with recommendations regarding the implementation of the OFPA; and (2) to develop the Proposed National List or amendments to the National List for submission to the Secretary. The NOSB has fulfilled this statutory role by providing the USD A with extensive, consensus recommendations on the acceptable practices governing virtually all aspects of organic farming, processing, handling and labeling. As directed by the OFPA, the NOSB compiled the final, initial National List of Allowed and Prohibited Substances. Despite these efforts, the USDA has significantly altered the majority of the NOSB’s recommended practices, directly altered the NOSB’s National List, removed the NOSB’s annotations and restrictions on use that accompanied the National List, and attempted to change the NOSB’s future governance of the National List process. Such an explicit challenge to the NOSB’s statutory authority is contrary to the OFPA and violative of the public/private partnership that supported Congressional passage of the OFPA. See, Appendix III.
Issue Number 4. Commenters Should Oppose All USDA Changes To The National List. (Comment Topic Heading: National List).
The USDA’s proposed rule explicitly challenges and takes away the NOSB’s statutory power to establish the National List of Allowed and Prohibited Substances. See, Appendix III. At a minimum, commenters should oppose these specific examples of USDA’s alteration of NOSB findings.
A. National Organic Standards Board.
(1). “Killed B.t.”. On November 1, 1995, the NOSB listed genetically engineered Pseudomonas florescens with a B.t. gene (“Killed B.t”) as synthetic and non-approved.
(2). Piperonyl Butoxide. On October 14, 1994, the NOSB rejected a motion to add Piperonyl Butoxide to the National List as an approved synthetic. NOSB, Final Recommendation, Addendum 2, “Botanical Pesticides Policy.”
(3). Chymosin. On September 20, 1996, the NOSB determined genetically engineered chymosin to be an unacceptable synthetic. “Summary of NOSB Recommendation for Materials Considered at Indianapolis, IN.”
B. USDA Proposed Rule.
(1). “Killed B.t.”. USDA ignored the NOSB and proposes that toxins derived from genetically engineered bacteria be placed on the National List of Active Synthetic Substances Allowed “so that [the agency] can receive comments on the proper classification of these substances, and whether they should be allowed, prohibited or allowed on a case-by-case basis” (Proposed § 205.20; 62 Federal Register 65889) and specifically lists “Killed B.t? as an allowed active synthetic (Proposed § 205.22(d); 62 Federal Register 65891).
(2). Piperonyl Butoxide. USDA ignored the NOSB finding and proposes that Piperonyl Butoxide be included on the National List of Active Synthetic Substances Allowed. (Proposed § 205.22(c)(9); 62 Federal Register 65891).
(3). Chymosin. USDA ignored the NOSB finding and proposes that genetically engineered chymosin be placed on the National List of Non-agricultural Substances Allowed “so as to solicit public comment.” (Proposed § 205.26; 62 Federal Register 65895).
Issue Number 5. Commenters Should Support the NOSB’s Prohibition on the Use of Genetic Engineering. (Comment Topic Heading: General/Crops/Handling/National List).
A. National Organic Standards Board Action.
The National Organic Standards Board recommended that the use of genetic engineering be prohibited in organic foods.
B. USDA Proposed Rule.
Under the preamble discussing proposed § 205.8, the USDA specifically set aside the NOSB’s prohibition of genetic engineering and opened up the question for comment. Additionally, in requesting comments on genetically engineered organisms (“GEOs”) the USDA fails to seek comment on whether GEO’s and their resulting products should be considered “synthetic.” 62 Federal Register 65875. As discussed in Appendix III, such an action could result in a de facto allowance of genetic engineering.
Other proposed sections that could be affected by this USDA proposal include § 205.9 (Prevention and Control of Crop Pests, Weeds, and Diseases), § 205.22 (National List) and § 205.26 (National List).
Issue Number 6. Commenters Should Support NOSB’s Broad Definition of Genetic Engineering. (Comment Topic Heading: General/Crops/ Handling/National List).
A. National Organic Standards Board Action.
As noted above, the NOSB recommended a prohibition on the use of genetic engineering because genetically engineered organisms and the products of such organisms are “synthetic.” The NOSB also recommended a comprehensive definition of genetic engineering. This was done to ensure that the recommended prohibition on genetically engineered foods, processes, and inputs encompasses all potential genetic engineering techniques. NOSB, Final Recommendation Addendum 25, “Definitions and Interpretations” (November 1, 1995).
B. USDA Proposed Rule.
Under proposed § 205.2(56), the USDA’s rejects the NOSB’s broad definition of genetic engineering and replaces it with an extremely narrow one. Should the USDA’s definition be in the final rule, it would seriously undermine any prohibition on genetic engineering.
Issue Number 7. Commenters Should Support the NOSB’s Prohibition on the Use of Municipal Sewer Sludge. (Comment Topic Heading: Crops/Handling/National List).
A. National Organic Standards Board Action.
Concerned with residue levels of heavy metals, pesticides and contaminants such as PCBs, the NOSB specifically found that “sewage sludge” was “synthetic” and “unacceptable for use in organic crop production.” “Summary of NOSB Recommendations for Materials Considered at Indianapolis, IN” (September 1996).
B. USDA Proposed Rule.
Under discussion of proposed § 205.22, USDA put aside the NOSB determination and asks for comments on whether sewer sludge should be permitted or prohibited in organic production and whether it should be defined as a “synthetic” or “non-synthetic.” 62 Federal Register 65893. As discussed in Appendix III, such an action could result in a de facto allowance of municipal sewer sludge.
Issue Number 8. Commenters Should Support the NOSB’s Prohibition on the Use of Ionizing Radiation (Irradiation). (Comment Topic Heading: Handling/National List).
A. National Organic Standards Board Action.
NOSB’s Final Recommendation, Addendum Number 7, “Organic Good Manufacturing Practices” (April 25, 1995) stated that ionizing radiation (irradiation) may not be used in the handling of organic food.
B. USDA Proposed Rule.
Under proposed § 205.17, the USDA ignored the NOSB’s recommendation and asks for comments on whether irradiation is compatible with organic farming and handling and whether it is an “essential standard industry practice” or “good manufacturing practice.” 62 Federal Register 65884. As discussed in Appendix III, such an action could result in a de facto allowance of irradiation.
Issue Number 9. Commenters Should Support the NOSB’s Recommendation Requiring Outdoor Access for Livestock. (Comment Topic Heading: Livestock).
A. National Organic Standards Board Action.
The NOSB, Final Recommendation, Addendum 8, “Organic Livestock Healthcare Practices” (April 25, 1995) found that “Certified organic livestock shall be based on a system that incorporates access to the outdoors and direct sunlight.” (Emphasis added).
B. USDA Proposed Rule.
Under the Livestock Living Conditions and Manure Management provision of proposed § 205.15(a), USDA states that producers must provide space for movement and outdoor access. However, USDA’s proposed § 205.15(b) makes the requirement for space for movement and outdoor access meaningless by providing a loophole allowing for the restriction of available space for movement and access to the outdoors “if necessary.” Further guidance on the “if necessary” qualifier is not given by USDA, thereby allowing each livestock producer the discretion as to when it is “necessary” to restrict space for movement and prevent outdoor access. As written, a livestock producer could find it is always “necessary” to restrict an animal’s space for movement and prevent an animal’s access to the outdoors.
Issue Number 10. Commenters Should Support the NOSB’s Prohibitions and Restrictions on the Use of Antibiotics in Livestock. (Comment Topic Heading: Livestock).
A. National Organic Standards Board Action.
(1). For livestock, NOSB recommended an absolute prohibition on antibiotic use in slaughter stock. The NOSB also recommended a restriction on antibiotic use in breeding stock to “healthcare emergencies.” However, in no case can the offspring of breeding stock be sold as organic if antibiotics are used during the breeder’s last third of gestation or nursing period. NOSB, Final Recommendation, “The Use of Antibiotics in Organic Livestock Production” (June 4, 1994).
(2). For laying hens, NOSB recommended restricting antibiotic use to only “healthcare emergencies,” and further recommended that eggs or egg products may not be sold or labeled organic until 90 days following antibiotic use. NOSB, Final Recommendation, Addendum 22, “The Use of Antibiotics In Organic Livestock Production” (October 31, 1995).
(3). For dairy cows, NOSB recommended restricting antibiotic use to only “healthcare emergencies,” and further recommended that milk or dairy products may not be sold or labeled organic until 90 days following antibiotic use. NOSB, Final Recommendation, “The Use of Antibiotics in Organic Livestock Production” (June 4, 1994).
B. USDA Proposed Rule.
(1). Under proposed § 205.14(b)(1) & (2), contrary to the NOSB recommendation on slaughter stock, USDA allows the use of antibiotics in the first twenty-one days of life in mammals. 62 Federal Register 65880. The USDA proposal fails to specifically address antibiotic use in breeder stock, laying hens and dairy cows.
(2). For non-mammal slaughter stock (i.e., poultry) the USDA allows the use of antibiotics within the first seven days after arrival at a certified facility. 62 Federal Register 65880. Once again, this is contrary to the NOSB recommendation and creates a potentially significant loophole that would allow antibiotic treated animals to be slaughtered and labeled organic.
(3). For non-slaughter stock (e.g. breeder stock, egg laying chickens and dairy cows), the USDA also goes against the NOSB recommendations. Under proposed § 205.14(d), the agency allows the use of the “organic” label on the product of antibiotic treated animals when the producer determines that the “animal has fully recovered.” 62 Federal Register 65880. USDA specifically rejects the NOSB 90-day waiting period requirement for laying hens and dairy stock. Additionally, USDA rejects the NOSB’s restriction on antibiotic use for breeding stock when nursing or in the last third of gestation. USDA only specifies that FDA drug withdrawal times be observed and an animal be determined to be fully recovered from the condition being treated. No definition or concrete guidance is offered regarding how this would be defined or such a judgment assessed. This loophole gives the producer significant discretion in determining the length of the waiting period necessary after antibiotic use.
Other notes. In the proposed rule’s preamble the USDA appears to be open to additional comments on the use of antibiotics in slaughter stock. 62 Federal Register 65880. This may allow USDA to create additional loopholes in the final rule.
Issue Number 11. Commenters Should Support NOSB’s Recommendations on Animal Feed. (Comment Topic Heading: Livestock).
A. National Organic Standards Board Action.
In order to preserve consumer confidence and ensure growth in the demand for organic meats, the NOSB found that all certified organically produced livestock shall be fed certified organically produced feeds and feed supplements. This included allowance for emergency non-organic feeding only for established time periods and after a certifying agent is notified. NOSB, Final Board Recommendation, “Livestock Feed Standard” (June 2, 1994).
B. USDA Proposed Rule.
Under proposed § 205.13(a)(l)(I), USDA will allow organic animals to receive up to twenty (20) percent non-organic feed as part of its total feed per year. 62 Federal Register 65878. In addition, the proposed rule allows for a greater percentage of feed to be non-organic “if necessary.” Similar to the USDA’s proposed provisions on outdoor access, this represents a significant loophole in the enforcement of organic feeding practices. See supra, Issue Number 9.
Issue Number 12. Commenters Should Support NOSB’s Fee Recommendations Concerning the Impact on Small Farms. (Comment Topic Heading: Fees).
A. National Organic Standards Board Action.
The NOSB recommended that the USDA use appropriated funds to cover the cost of the first round of accreditation. NOSB, Final Recommendation, “Standards and Procedures Governing the Accreditation of Organic Certification Organizations” (June 4, 1994). It was the NOSB’s intention that these costs then be analyzed so a fair and equitable fee structure could be established for the next round of accreditation.
B. USDA Proposed Rule
Under proposed §§ 205.421 – 205.425. USDA creates a regressive, flat fee structure that will make participation in the National Organic Program by small certifiers, farmers and handlers economically burdensome.
Issue Number 13. Commenters Should Support the NOSB’s Prohibition on the Use of Inert Ingredients. (Comment Topic Heading: Crops/Handling/National List).
A. National Organic Standards Board Action.
On April 11, 1995, the NOSB voted to prohibit the use of synthetic inerts contained in EPA List 1 – “Inerts of Toxicological Concern,” EPA List 2 -“Potentially Toxic Inerts,” and EPA List 3 – “Potentially Toxic Inerts.”
B. USDA Proposed Rule.
Under proposed § 205.20(b)(3) the USDA ignored NOSB’s recommendations on synthetic inerts. The USDA proposes limiting the prohibition on use to inerts on EPA List 1, and allows the use of formulated products containing inerts included on EPA List 2, and EPA List 3. 62 Federal Register 65890.
Other Major Issues.
Issue Number 14. Commenters Should Oppose USDA’s Eco-Labeling Prohibitions. (Comment Topic Heading: Labeling).
Under § 205.103, the USDA proposes to regulate “the labeling or market information that directly or indirectly imply organic production and handling practices.” This includes a prohibition on the use of terms that directly or indirectly imply organic production if the products being labeled are not produced in accordance with OFPA. Some of examples of the prohibited labeling include “produced without synthetic pesticides,” “pesticide-free farm,” “no growth stimulants administered,” “raised without antibiotics,” “humanely raised” and “ecologically produced.” This broad prohibition would prevent new eco-labeled products from entering the market and could force many U.S. companies and grower associations who currently produce and label eco-products to remove them from the market. See, Appendix IV, “Brief Legal Analysis of Labeling Issues.”
Issue Number 15. Commenters Should Oppose USDA’s Definition of “Unavoidable Residual Environmental Contamination.” (Comment Topic Heading: General).
USDA has ignored NOSB recommendations and defined this term to give the Secretary discretion in determining (on a case-by-case basis) whether environmentally contaminated land may be used for organic food production. 62 Federal Register 65866-65867 and 65932. This creates a significant loophole that may allow many of the proposed rule’s requirements to be circumvented.
Issue Number 16. Commenters Should Seek Clarification on the Procedures Addressing the Importation of Foreign Organic Products. (Comment Topic Heading: Equivalency).
Under § 6505(b) of the OFPA and USDA’s proposed §§ 205.480 – 205.483, all determinations on the eligibility of agricultural products for importation as organic shall be made by the Secretary of Agriculture. Three notes on this: (1) the maintaining of eligibility for importation of organic products will depend on “periodic reviews by the Secretary.” It is unclear as to how often the “periodic reviews” will be undertaken; and (2) the USDA’s proposed rules do not determine how to deal with maintaining organic integrity during pre-shipment and quarantine activities due to importation (e.g., will treatments of imports by fumigants during quarantine be considered equivalent to the national organic standards).
APPENDIX I
USDA’s National Organic Program: Procedural Issues
A request for withdrawal or recision (and reproposal) of the rule could be based on a claim that the current proposed rule on its face is arbitrary, capricious and an abuse of discretion and thereby violative of the Administrative Procedure Act, 5 U.S.C. § 551, et seq., OFPA, and other relevant statutes and regulations. This request could be based on at least two general considerations:
- Failure To Provide Sufficient Notice. The proposed rule may be defective in that it fails to provide sufficient notice as to the contents of the final rule. Generally, proposed rules must be specific in intent and may not leave out (or in this case leave undetermined essential elements of issues). See, e.g., National Tour Brokers v. United States, 591 F. 2d 896 (D.C. Cir. 1978); Kollett v. Harris, 619 F. 2d 134 (1st Cir. 1980). As a result of USDA’s proposed definition of genetic engineering and its provisions on genetic engineering, irradiation, sludge, etc . . . commenters could claim that the notice as to the agency’s intent is inadequate on which to base any final rule, and that the agency should therefore withdraw the rule until they have sufficiently determined both the direction and basis for their actions. USDA has already made public admissions that could be legally significant in this regard, stating, “Anyone can offer opinions about the rule. Nothing is set in concrete. Some of these issues were not thoroughly addressed.” (Cindy Skizycki, “Organic Proposal Leaves a Bad Taste in Some Mouths,” Washington Post, December 26, 1997) (emphasis added).
- Ultra Vires Action. Numerous substantive and procedural provisions in the proposed rule may violate OFPA requirements defining the relationship between the USDA and the NOSB. Therefore significant portions of the rule may be ultra vires — beyond the agency’s statutory authorization. (“When Congress passes an Act empowering administrative agencies to carry on governmental activities, the power of those agencies is circumscribed by the authority granted.” (Oft-cited holding in Stark v. Wickard, 321 U.S. 288, 309 (1941)). (For in-depth analysis of this issue see Appendix III).