Section 205.236(a)(2) should be amended to read:
“(2) Dairy Animals. Milk or milk products must be from animals that have been under continuous organic management beginning no later than 1 year prior to the production of the milk or milk products that are to be sold, labeled, or represented as organic: Except, That, when an entire, distinct dairy herd is converted to organic production, the certifying agent may grant the following exemption:
(i) During the first 9 months (270 days) of the 12 month conversion period, up to 20% of the daily ration may consist of non-organic feed, with the remaining 80% of the ration composed of certified organic feed or feed produced on-farm that is eligible for certification prior to the final 90 day period;
(ii) Animals must be fed 100% certified organic feed for at least the final 3 months (90 days) prior to the production of milk or milk products to be sold, labeled, or represented as organic;
(iii) Once a dairy operation has been converted to organic production, all dairy animals shall be under organic management from the last third of gestation: Except, That transitional feed raised on the farm may be fed to young stock up to twelve months prior to milk production, and Except, for emergency replacement stock due to animal accident or disease.”
Rationale: Section 205.236(a)(2) contains no allowance for a new herd dairy clause. The proposed language seriously inhibits the ability of small dairy farms to convert to organic production. The proposed rule should be amended to allow a one time conversion of a dairy operation, with allowance for 9 months at 80% organic feed and 3 months at 100% organic feed.
Replace “birth” with “the last third of gestation”.
Rationale: Organic management for breeder and dairy stock being used as slaughter stock should be consistent with the requirement that slaughter stock offspring of breeder stock brought onto an organic operation must be under organic management from the last third of gestation (205.236(a)(4)). This is consistent with OFPA, NOSB, and AOS.
53. New subsection 205.236(b)(4)
Insert a new section 205.236(b)(4):
“(4) Livestock from embryo transfer and/or cloning techniques are prohibited for use as organic breeding, production, or slaughter stock.”
Rationale: Section 205.236(b)(3) prohibits animals from excluded (genetic engineering) methods. OTA supports this provision. 205.236(b)(3) does not address cloned animals or animals from embryo transfer. Both of these techniques involve reliance on synthetic hormones and antibiotics and should be clearly prohibited. This would be consistent with Codex Guidelines and AOS.
Amend Section 205.236(c) by adding the following:
“(c) The producer of an organic livestock operation must maintain an audit trail sufficient to preserve the identity of all organically managed livestock and edible and nonedible livestock products produced by the operation. The audit trail must permit tracing the sources and amounts of all livestock, feeds, feed supplements, feed additives, and medications. Livestock health records which document all health problems and the practices and materials used for treatment must be maintained.”
Rationale: Section 205.236(c) states that an “organic livestock operation must maintain records sufficient to preserve the identity of all organically managed animals …” Records which show the source of animals, feed, feed additives, medications, health care actions, and sales are not addressed. The maintenance of such records is essential to assess a livestock operation’s compliance to organic standards, as recognized by the NOSB recommendation. (Santa Fe, June, 1994, Sligh, p. 96) This is also consistent with Codex Guidelines and AOS.
Delete the words “and supplements” from the end of section 205.237(a).
Rationale: Section 205.237(a) states that “nonagricultural products and synthetic substances allowed under § 205.603 may be used as feed additives and supplements.” Allowing nonagricultural products and synthetic substances to be used as feed supplements contradicts the definition of feed supplements in Subpart A, which defines feed supplements as “a feed used with another feed ….” The definition of “feed” states that “the term ‘feed’ encompasses all agricultural commodities ….” There is no mention in the definition of either “feed” or “feed supplement” of “nonagricultural products and synthetic substances.” The words “and supplements” needs to be deleted from the end of section 205.237(a), if “feed supplement” is defined as a “feed used with another feed.”
56. New subsection 205.237(b)(7)
Add a new subsection (7):
“(b) The producer of an organic operation must not:
(7) Use feed, feed supplements, and feed additives produced with excluded methods: Except, That,
(i) If non-excluded method sources of vitamins have not been developed, submitted, and approved for inclusion on the National List by the time of implementation of OFPA, there should be temporary allowance, for the welfare of the livestock, of vitamins with carriers or manufacturing techniques that may include products of excluded methods.”
Rationale: This section in the proposed rule does not prohibit the use of genetically engineered feed, feed supplements, or additives. The suggested amendment would prohibit feed from excluded methods, while providing a temporary allowance for the use of vitamins which may be made with or contain carriers made from excluded methods, during an implementation period during which time non-excluded feed supplements and additives are placed on the National List.
The preamble to the rule states that organic does not include GMOs. OTA agrees that vitamins should be non-GMO, but there is grave concern that especially vitamins will be unavailable for the welfare of the livestock when the rule is implemented, if there is not some sort of sunset allowance until non-GMO sources are developed and approved.
205.238(a)(5) reads: “Performance of physical alterations as needed to promote the animal's welfare and in a manner that minimizes pain and stress; and….”
OTA applauds the inclusion of a standard regarding animal welfare. No change is recommended.
After “the last third of gestation” insert “or during lactation".
Rationale: This section is in reference to allowance of the use of parasiticides, and should be revised to prohibit such use during lactation. This is consistent with AOS.
59. New subsection 205.238(c)(8)
Add a new subsection 205.238(c)(8):
“(c) The producer of an organic livestock operation must not:
(8) Use animal drugs produced with excluded methods: Except, That,
(i) If non-excluded method sources of vaccines and biologics have not been developed, submitted, and approved for inclusion on the National List by the time of implementation of the rule, there should be temporary allowance, for the welfare of the livestock, of vaccines and biologics with carriers or manufacturing techniques that may include excluded methods.”
Rationale: Section 205.238(c), as drafted in the proposed rule, does not prohibit the use of genetically engineered animal drugs. The preamble states that organic does not include GMOs. OTA agrees that animal drugs should be non-GMO, but there is grave concern that vaccines and biologics will be unavailable for the welfare of the livestock when the rule is implemented if there is not some sort of sunset allowance until non-GMO sources are developed and approved. This is consistent with the Codex Guidelines. It is also consistent with the European Union regulation, (209291), which states:
“Article 6 (1)(d) Genetically modified organisms and/or any product derived from such organisms must not be used, with the exception of veterinary medicinal products.”
After “including” add “, but not limited to”
Rationale: The current phrasing of section 205.238(a) would require a producer to implement all of the practices and administer all of the inputs listed under the subsection in order to be in compliance. Inserting the phrase “but not limited to” shows that the listed practices and inputs are indicative, but not necessarily prescriptive.
After “veterinary biologics” add “as needed”.
Rationale: The rule needs to be clear that the “administration of vaccines and other veterinary biologics” is optional - it is not mandatory. Such inputs should only be used when needed, such as when a disease is endemic to an area, or when their use is required by law.
Amend to read:
“(1) Breeder stock, when used prior to the last third of gestation, but not during lactation, for progeny that are to be sold, labeled, or represented as organically produced; and”.
Rationale: Section 205.238(b)(1) prohibits breeder stock from receiving parasiticides during the last third of gestation, but they still could receive parasiticides while lactating. The use of parasiticides also needs to be prohibited for lactating animals.
63. New section 205.240
Insert a new section 205.240 to set minimum standards for apiculture.
(a) Bees, and products obtained from them, can be sold, labeled or represented as organically produced, if managed in accordance with the Act and regulations in this part for at least 60 days prior to the collection of organic apiculture products.
(b) Bees from which organic apiculture products are harvested shall have access to forage produced in accordance with the Act and regulations in this part, provided that the hives are located on certified organic land and are not within 2 miles of a sanitary landfill, incinerator, power plant, golf course, town or city, crops sprayed with prohibited substances, crops grown with excluded methods, or other sources of contamination, as described in the organic system plan submitted by the producer and approved by the certifying agent. The minimum distance may be increased by the certifying agent, if deemed necessary, on a case by case basis.
(c) Feeding of bee colonies where conditions require reserves to be built up for winter may be undertaken. Feeding must be carried out between the last honey harvest and the period of dormancy of the colony.
(1) Feed must be derived from organic honey or organic sugar syrup: Except, That, non-organic honey or sugar syrup is allowed on a temporary and limited basis with written justification of need and documentation of the lack of organic feed sources, and must be approved by the certifying agent.
(2) The feeding of non-organic honey or sugar syrup is prohibited when honey supers are in place or during the 30 days preceding the placement of honey supers on the hive.
(d) The health of bee colonies must be maintained by good apiary practices, which include, but are not limited to:
(1) The use of hardy breeds that adapt well to the local conditions;
(2) Regular renewal of queen bees;
(3) Regular cleaning and disinfection of equipment;
(4) Use of non-contaminated foundation wax;
(5) Destruction of contaminated materials;
(6) Regular renewal of beeswax; and
(7) Availability in hives of sufficient pollen and honey.
(e) The producer of an organic apiculture operation must not:
(1) Acknowledge the presence of pests, parasites or diseases without efforts to restore the health of the colony;
(2) Use prohibited pesticides for the prevention or control of pests or parasites;
(3) Use antibiotics, sulfa products, or any drug not on the National List;
(4) Use pressure treated lumber for hive construction materials;
(5) Use chemical bee repellents;
(6) Perform wing clipping; or
(7) Cycle hives between conventional and organic management.
(f) An operation which processes or handles organic honey must be in compliance with all applicable handling requirements of the Act and regulation in this part.
(g) If a facility processes both organic and non-organic honey, all equipment, including containers and lines used to transport and/or store honey, must be completely emptied and cleaned prior to processing organic honey.
(h) Equipment which comes in contact with honey must be made of stainless steel, glass, or other food grade materials.”
Rationale: Honey and other apiculture products are currently being produced and marketed as certified organic. Several State and private certifying agents have set organic apiculture standards. Not including apiculture standards in the rule will force certifying agents to either refuse to certify such operations or to certify to additional requirements not included in the rule. The Organic Trade Association’s American Organic Standards include apiculture standards. These are based on existing State, private, and international standards.
After “fresh air”, insert “outdoors”.
Rationale: The proposed rule does not actually require “access to the outdoors.” Please note that the NOSB Final Recommendation Addendum #8 on Organic Livestock Healthcare Practices, (Orlando, April, 1995, Sligh, p. 116), states, “Certified organic livestock farms shall be based on a system that incorporates access to the outdoors and direct sunlight….” This is consistent with Codex Guidelines and AOS.
The language in this section needs to be clarified, either be defining “ionizing radiation” as not including the use of X-rays in metal detectors, or by specifically allowing the use of metal detectors in this section.
OTA recommends using the AOS definition of ionizing radiation, with an additional statement regarding metal detection:
“Ionizing radiation (irradiation). High energy emissions from radionuclides, (such as cobalt-60 or cesium-137), capable of altering a food’s molecular structure for the purpose of controlling microbial contaminants, pathogens, parasites and pests in food, preserving a food, or inhibiting physiological processes such as sprouting or ripening, but does not include X–rays used for metal detection.”
Rationale: Section 205.270(c)(1) prohibits the use of “ionizing radiation for any purpose.” The prohibition of irradiation was strongly supported by public comments, and OTA supports its prohibition in this rule. Without a definition of “ionizing radiation,” however, it is unclear if this section prohibits the use of X-rays in metal detectors. Metal detectors are an important tool for quality control and food safety, to prevent products containing metal fragments from entering the market. So long as it is clear from the definition that “ionizing radiation” does not include X-rays used in metal detectors, than the language in 205.270(c)(1) can remain as drafted. If the definition does not exempt X-rays in metal detectors, than a specific exemption needs to be inserted in this section.
66. 205.271(c) and new subsections (1) and (2)
Rewrite 205.271(c) as follows:
“205.271 Facility pest management practice standard
(c) If the practices provided for in paragraphs (a) and (b) of this section are not effective to prevent or control facility pests, a nonsynthetic biological or botanical substance except for those listed in 205.602 or 205.604, or a synthetic substance as provided in section 205.601, 205.603 or 205.605 may be applied to prevent, suppress, or control pests: Provided, That, the substance is applied in the manner consistent with its label as approved by the Federal, State, and local regulatory authorities.
(1) If the practices provided for in paragraphs (a) and (b) and (c) of this section are not effective to prevent or control facility pests, a synthetic substance may be applied to prevent, suppress, or control pests: Provided, That, the substance is applied in the manner consistent with its label as approved by the Federal, State, and local regulatory authorities, and
(2) All organic food, feed, fiber and related packaging materials must be removed from the treated area before and during the application of the synthetic pest control substance. For synthetic pesticides applied by fogging or fumigation, re-introduction of organic ingredients, products or packaging to the treated area must not occur until after three times the re-entry period for the pesticide, or 24 hours, whichever is the longer. All food contact surfaces exposed to synthetic pesticides must be cleaned and rinsed with approved materials before organic handling resumes.”
Summary: The proposed rule does not require organic product removal before application of synthetic pest control substances and does not provide for a mandatory elapse time before reintroduction of organic products into a previously treated facility. Like AOS, it does not allow use of any synthetic pest control material, until after all preventative methods have failed. The organic handling plan must identify measures taken to prevent contact with prohibited materials, under 205.271(d).
Rationale: Although the revised rule does address the issue of contact with prohibited materials, it should be strengthened. It should clearly prohibit fumigation with synthetic materials while organic products are present, require removal of organic products and packaging materials during treatment with a synthetic pest control material, and bar the return of organic products and packaging materials to a treated area until the treatment has dissipated. This is a standard industry practice, and OTA sees no reason not to clearly state this prohibition. Consumers expect that organic products are not subject to prohibited pest control practices during the handling process.
Note that 205.271(c) and (d) resemble the language in AOS 7.5.2. However, it differs in that 205.271(d) requires that handlers “must include in the organic handling plan a list of all measures taken or intended to be taken to prevent contact [with prohibited materials]”, which seems weaker than requiring no contact. This is almost identical to the provisions in the original proposed rule, with the change made to require the organic plan to list preventive measures. Section 205.272(a) provides additional language that protects against contact with prohibited materials. The amendments suggested above need to be incorporated in order for the rule to be consistent with current industry practices, certification standards, and consumer expectations.
67. New subsection 205.290(a)(4)
Insert a new subsection 205.290(a)(4), to read:
“(4) To qualify for an emergency variance from organic feed requirements, the operator must document efforts to obtain organic feed in advance of the depletion of feed reserves, establish an emergency feed plan in the operation’s organic system plan, and receive approval from the certifying agent. The operator must obtain feed based on the following order:
(i) Certified organic feed;
(ii) Non-certified organic feed;
(iii) Feed grown under organic management for two years;
(iv) Feed grown under organic management for one year; and
(v) Conventional feed.
(vi) Transitional or conventional feed must be fed first to animals furthest away in time from production of products intended to be sold as organic.”
Rationale: Section 205.290 “Temporary variances,” does not incorporate the NOSB recommendations on temporary feed emergencies. (Santa Fe, June, 1994, Sligh, p.94) Unless the amendments suggested above are incorporated, there is no allowance in the rule for temporary feed emergencies. Allowances for temporary feed emergencies are consistent with Codex Guidelines and AOS. As proposed above, they are tightly regulated by the certifying agent.
Subpart D - Labels, Labeling, and Market Information
Rewrite 205.300(a) to read:
“a) The terms, "organic," "biologic," and "ecologic", their abbreviated forms, and phrases containing these terms, may only be used on labels and in labeling of raw or processed agricultural products, including ingredients, that have been produced and handled in accordance with the regulations in this part.”
Rationale: The terms "biologic" and "ecologic" are international synonyms for "organic." In order to facilitate international trade and the negotiation of equivalency agreements, OTA proposes that these terms be regulated the same as "organic." This position is consistent with the Codex Guidelines, European Union regulations, and AOS. The rule needs to be clearly limited to these 3 terms, however, leaving other “eco labels” open for market development and interpretation.
In addition, OTA supports the NOP position, as stated in the preamble, (F.R. 13555), that it intends to “monitor use of the term “organic” in product and company names” and take action against uses that it finds to be “false or misleading.”
After “…regulations in this part”, delete “.” and insert “: Except, That, any labels in inventory or being printed at the time of the publication of the Final Rule may continue to be used for a period of not more than 18 months.”
Rationale: The FDA set a precedent in their National Nutritional Labeling Act of 1994 when they allowed the industry a minimum of 18 months to use up label inventory. As written, there is no timeline in the rule for a processor or producer to use up their label inventory. The USDA must include this kind of timeline in the rule. Please refer to NOSB phase-in language. (Orlando, April, 1995, Sligh, p. 82)
Insert after “…organically produced raw or processed agricultural product.”, the sentence “Any processed agricultural products used must themselves be 100 percent organic, not merely products labeled as ‘organic’.”.
Rationale: The wording of the “100 percent organic” section appears to allow products with less than 100 percent organic ingredients. As written, the proposed rule allows formulation of a multi-component product using “organically...processed agricultural product”. The next paragraph, 205.301(b) defines a processed agricultural product labeled as “organic” as one containing not less than 95 percent organically processed agricultural product. Under the proposed wording, it appears that one could make a 100 percent organic product by buying two or three “organic” ingredients, combining them without using any processing aid, and yet the organic content (excluding water and salt) could be as low as 95 percent.
Example: A processor buys “Organic Sucrose”, “Organic Corn Syrup”, and “Organic Grape Juice Concentrate” to make an Organic Candy. Nothing is added to the mixture, other than cooking to reduce water content. In the proposed wording, 100 percent of the product is sold to the processor as “organic”, he used no processing aids, so the processor labels it “100 percent organic”. The ingredient declaration simply shows: “organic sucrose, organic corn syrup, organic grape juice concentrate” (assuming that’s the correct order in percent composition). But the “organic sucrose” may have been made with non-organic filter aids; the “organic corn syrup” could have been made with non-organic enzymes and other processing aids; and the “organic grape juice concentrate” could also have been made using enzymes and filter aids.
By spelling out that each ingredient in a product must be 100 percent organic, whether it be raw organic or processed agricultural product, the rule would avoid ambiguity.
Insert after “…raw or processed agricultural product.”, the sentence, “An agricultural substance that is not organically produced may be used in a processed product labeled as “organic” on the principal display panel only if the agricultural substance has been shown to be commercially unavailable in organic form.”
Rationale: As written, the product must contain 95% organic ingredients and 5% materials on the National List. There are no requirements to use organic ingredients in the 5%, if available. OTA strongly supports a requirement that processors must attempt to source organic agricultural ingredients as a first option, in all instances. This fundamental concept, as stated in AOS, is currently implemented in the industry, and is verified through inspection and certification. It would not place an undue burden on manufacturers or certifying agents, and would support the development of minor ingredients and specialty crops from organic sources.
Insert a new subsection 205.301(b)(1):
“Nonorganically produced agricultural substances may be used in the less than 5% fraction when organic sources are not available, as documented in the organic handling system plan (205.201(a)(2)(i).”
Rationale: As written, the proposed rule limits application of the concept of commercial availability to the selection of organic or untreated seeds and planting stock. On April 25, 1995, in Orlando, Florida, the NOSB recommended a policy of “commercial non-availability of suitable ingredients in organic form.” (Sligh, p. 73) The language suggested in the two points above is consistent with the NOSB recommendation. The inclusion of this policy for producers and handlers is essential for the organic industry.
OTA recommends NOP adoption of the following policy for use in its program manuals for determining commercial non-availability, ( as approved by OTA’s Certifiers Council Steering Committee, January 14, 2000):
“Determination of Commercial Non-Availability of Organic Ingredients
I. Documentation of Non-Availability
A. Applicant must submit written report to certifier as part of the Organic Handling Plan that lists:
1. Known sources of ingredient, and organic status or lack thereof.
2. Written evidence of effort to locate sources of organic ingredients: including letters and phone logs of discussions with suppliers. In discussions with suppliers, it is recommended that at least three suppliers be contacted.
3. Estimate of volume of ingredient needed within specified time if this is a factor in requested allowance of non-organic ingredient.
4. Explanation of how ingredient is used to fulfill an essential function, and that there are no acceptable alternatives that may be sourced organically
B. The certification agent must:
1. Verify that the handler has made a good faith effort to source organic ingredients. Evaluate claim that no organic substitutes are available.
2. Keep a list of ingredients that have been granted allowances in non-organic forms.
3. Make this information available to the National Organic Program.
4. Update these lists on a regular basis as ingredients become available in organic form.
5. Investigate availability when new information or complaints are received.
6. Require applicant to update this information in annual Organic Handling Plan.
7. Require change in label if it determines that sufficient documentation to justify use of a non-organic ingredient is absent. Products without sufficient documentation may not be labeled "organic" but may be labeled as "made with organic ingredients."
A. If another certifier or handler feels that an ingredient has been allowed as non-organic that is in fact available organically, a written complaint may be filed with the National Organic Program. Complaint should provide specific information regarding organic sources of ingredient in question.
B. The certifier that approved the non-organic use shall have an opportunity to review availability and present evidence for decision. If there continues to be disagreement on the status of the ingredient, the issue shall be resolved using a mediation process.”
Section 205.301(c) contains a new provision, that for 50% and above label claims, the non-organic ingredients must not contain or be created using excluded methods, sewage sludge, or ionizing radiation. This is consistent with consumer expectations as expressed in comments on the last Proposed rule, and the concept is supported by the OTA. It places new burdens on manufacturers, inspectors, and certifying agents, however, and raises questions about how to verify production and handling practices used for nonorganic ingredients. NOP, in consultation with the NOSB, will need to develop guidance documents, possibly in the form of program manuals, on how compliance with this provision is to be assessed. NOP will also need to provide assistance to manufacturers and certifying agents concerning the availability of nonorganic ingredients which comply with this requirement.
It will be extremely difficult or impossible to document that some non-organic ingredients are produced without sewage sludge. For this reason, it is important that NOP allow a variance, based on the “commercial unavailability” concept, for the use of non-organic ingredients where documentation on production without sewage sludge is not available from suppliers.
Under the “commercial unavailability” variance, the certified organic handler is required to demonstrate and document to the certifying agent that it has made a thorough effort to source non-organic ingredients with proper documentation about sewage sludge. If the handler cannot find a supplier with adequate documentation that a non-organic ingredient was produced without sewage sludge, the certification agent should grant a variance and allow the use of the non-organic ingredient in products labeled as “organic” and/or “made with organic ingredients.”
The proposed rule prohibits the use of sewage sludge in organic production. OFPA does not extend that prohibition to non-organic ingredients used in products labeled as “organic.” The proposed rule creates an unreasonable burden for organic handlers by extending this prohibition to non-organic ingredients. It is reasonable to require a certified organic handler to make a thorough effort to source non-organic ingredients produced without sewage sludge. It is not reasonable, however, to penalize the certified handler with removal of the organic label and de-certification, because the non-organic ingredient cannot be sourced with adequate documentation about the use of sewage sludge during its production. A variance for certified handlers who demonstrate thorough efforts to source non-organic ingredients with adequate documentation about sewage sludge is necessary to prevent disruption in organic trade.
OTA asserts that meeting the requirement the 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, mandatory, 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.