All USDA certifying agents and certified operations should consider the USDA response as the most current guidance on each of these matters.

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1 USDA RESPONSE TO NOSB FEEDBACK ON ISSUE STATEMENTS: FISHMEAL, INERTS, ANTIBIOTICS, AND SCOPE OF AUTHORITY Belw are the summaries f feedback frm the NOSB n fur issue statements related t: fishmeal as a feed supplement; the use f apprved pesticidal treatments that may cntain unknwn inert ingredients; the use f antibitics and ther synthetic medical treatments fr livestck; and the scpe f authrity fr NOP rganic standards regarding eligibility. The summary f each f the NOSB feedback statements is fllwed by the Department s respnse in bld and italics. The full statements issued by the NOSB can be fund at: All USDA certifying agents and certified peratins shuld cnsider the USDA respnse as the mst current guidance n each f these matters. NOSB Statement: ISSUE 1. FISHMEAL Fishmeal is nnsynthetic. Fishmeal preserved with natural substances and that wuld nt be harmful t human health r the envirnment shuld be allwed as a feed additive r feed supplement fr rganic prductin, in accrdance with 7 CFR (a), 7 CFR (b)(2) and 7 CFR (a)(2). The use f fishmeal must cmply with all applicable requirements f the Federal Fd, Drug, and Csmetic Act (FFDCA, 21 U.S.C. 301 et seq.), as required by 7 CFR (b)(6). Nnsynthetic (natural) preservative ingredients are allwed in fishmeal used in rganic prductin. Synthetic preservative ingredients may nly be used in fishmeal after petitin, review, and placement n the Natinal List. USDA-NOP Respnse t NOSB Statement: 1. NOP cncurs that fishmeal is nnsynthetic and that fishmeal preserved with natural substances may be allwed as a feed additive r feed supplement; 2. NOP further cncurs that use f fishmeal must cmply with FFDCA requirements; and 3. NOP cncurs that any synthetic preservatives added t fishmeal must first be added t the Natinal List thrugh rulemaking; hwever, the issue f added synthetics is currently the subject f Federal curt litigatin and final actin n this issue must await the utcme f the litigatin. NOSB Statement n Future Wrk: The status f fishmeal fr use in rganic aquaculture shuld be cnsidered during the develpment f NOP aquaculture standards. Issues including the sustainability f fisheries explited fr fishmeal prductin and pssible heavy-metal, PCB, dixin, and pesticide cntaminants in fishmeal shuld be addressed during the develpment f aquaculture standards. If NOP standards and definitins are develped fr the prductin f rganic fishmeal, then nly rganic fishmeal can be used as a feed, feed supplement, r feed additive fr any rganic livestck, in accrdance with 7 CFR (a), which requires the use f rganic feed.

2 A clear, predictable plicy needs t be develped cncerning when incidental substances in livestck and crp prductin materials make an therwise natural substance a synthetic. T help clarify the distinctin between natural and synthetic substances, the Livestck Cmmittee recmmends that the current definitin f nnsynthetic (natural) in the regulatins be revised. The Assciatin f American Plant and Feed Cntrl Officials (AAPFCO) definitin f natural and natural rganic fertilizers shuld be cnsidered in the revisin prcess. T clarify the differences between feed, feed additives, and feed supplements, the NOP and NOSB shuld prvide guidance cncerning the types f nutrients (carbhydrates, prteins, fats, amin acids, vitamins, and minerals) allwed in each categry and whether limits shuld be set n the quantities f nnrganic feed additives r supplements allwed in rganic feed ratins. USDA-NOP Respnse t NOSB Statement n Future Wrk: 1. The NOSB shuld place these issues n their wrking plans fr future Bard meetings. If any recmmendatins frm these future meetings result in prpsed regulatry changes, NOP will cnsider issuing a prpsed rule fr public cmment. 2. NOP has published a ntice in the Federal Register calling fr nminatins fr a taskfrce t help develp standards fr farm-raised and wild-caught fish. This task frce may address issues related t fishmeal.

3 ISSUE 2. UNKNOWN INERTS NOSB Statement: The NOSB encurages pesticide manufacturers wh want t market their prducts fr rganic prductin t take advantage f the Envirnmental Prtectin Agency (EPA) rganic labeling prgram. They are als encuraged t disclse all prduct ingredients, including inert r ther ingredients n the pesticide label. Pesticide manufacturers f prducts that cntain allwed active ingredients and List 3 inert ingredients are encuraged t refrmulate thse prducts t cntain nly List 4 inerts, which are allwed under NOP regulatins. Other ptins are t ntify EPA f a need fr expedited review, and t petitin the NOSB fr review f the specific List 3 inert. Since the EPA regulates use claims, directins fr use, and cmpsitin f a pesticide prduct as a pre-market cnditin, the NOP shuld establish functinal lines f cmmunicatin with EPA in rder t prvide EPA cnsistent infrmatin abut rganic standards and updates t the Natinal List, and t btain advice frm EPA n the status f petitined materials. Certificatin agents wh find that prducers are reprting use f pesticide prducts with unknwn inert ingredients shuld instruct prducers t discntinue use immediately unless the ingredients can be verified as cmpliant with the NOP regulatin. Discntinuatin f use will be cnsidered sufficient crrective actin fr use f pesticide prducts with apprved active and unknwn inert ingredients. USDA-NOP Respnse t NOSB Statement: 1. The NOP regulatins allw nly List 4 inert ingredients in the frmulatin f pesticide prducts used in rganic prductin, and List 3 inerts that appear n the Natinal List. 2. Certifying agents shuld ensure that certified peratins use pesticides that are knwn t them t cntain nly List 4 (and any apprved List 3) inert ingredients. 3. USDA-NOP may initiate enfrcement actins against any certified peratin using a pesticide that USDA-NOP can shw cntains an inert ingredient ther than a List 4 (r apprved List 3) inert.

4 ISSUE 3. ANTIBIOTICS NOSB Statement: NOP shuld issue a statement clarifying that the use f antibitics and ther prhibited substances is nt allwed fr rganically prduced livestck r edible rganic livestck prducts nce a prducer is certified rganic. NOP shuld adpt the May 14, 2003, NOSB recmmendatin n Origin f Livestck as either a technical crrectin (preferable) r as a rule change. This actin will unify and clarify the standard fr dairy herd replacement stck. The vast majrity f rganic dairy prducers and accredited certifying agents endrse this recmmendatin. The apprval f NOSB recmmended health care materials fr livestck must be a pririty fr the USDA. NOP shuld publish the amendment t the regulatins that will allw the use f all livestck materials recmmended by the NOSB. NOP shuld prvide t the industry the pprtunity t petitin fr inclusin f calf-hd medicatins n the Natinal List. USDA-NOP Respnse t NOSB Statement: 1. NOP cncurs that the use f antibitics and ther prhibited substances is nt allwed fr rganically prduced livestck r their edible prducts nce a prducer is certified rganic. 2. NOP is prcessing the rulemaking dcket addressing NOSB-recmmended livestck materials fr publicatin in the Federal Register. Operatrs and certifying agents are reminded that unless and until the final rule cntaining NOSB-recmmended materials is published in the Federal Register and becmes effective, the recmmended materials may nt be used. 3. Fr USDA s respnse t the NOSB recmmendatin n the rigin f replacement dairy stck, see issue 3a belw. 4. Prducers and manufacturers are directed t the NOP website fr prcedures n hw t petitin t add medicatins and ther materials t the Natinal List.

5 ISSUE 3A. ORIGIN OF LIVESTOCK NOSB Statement: The NOSB recmmends that 7 CFR (a)(2)(iii) be amended t read: 7 CFR Origin f livestck. (2) Dairy animals cnversin f cnventinal dairy herds. Milk r milk prducts must be frm animals that have been under cntinuus rganic management beginning n later than 1 year prir t the prductin f the milk r milk prducts that are t be sld, labeled, r represented as rganic, Except, That, when an entire, distinct herd is cnverted t rganic prductin, the prducer may: (i) Fr the first 9 mnths f the year, prvide a minimum f 80-percent feed that is either rganic r raised frm land included in the rganic system plan and managed in cmpliance with rganic crp requirements; and (ii) prvide feed in cmpliance with 7 CFR fr the final 3 mnths. (3) Replacement dairy stck -- Once a dairy herd has been cnverted t rganic prductin, all dairy animals shall be under rganic management frm the last third f gestatin. NOSB als recmmends that fr purpses f cnfrmity existing 7 CFR (a)(3) be renumbered t 7 CFR (a)(4). USDA-NOP Respnse t NOSB Statement: 1. The exceptin related t the feed prvisin is currently the subject f Federal curt litigatin and final actin n this issue must await the utcme f that litigatin. 2. NOP will cnsider drafting an advance ntice f prpsed rulemaking (ANPR) t btain infrmatin frm the public n the issue f dairy livestck, including the length f time that dairy livestck must be managed rganically befre dairy prducts may be sld as rganic.

6 ISSUE 4. SCOPE OF NOP REGULATIONS A. NOSB Statement: Persnal Care Prducts, Csmetics, and Dietary Supplements The NOSB encurages the Organic Trade Assciatin, cnsumer grups, affected industries, and ther stakehlders t slicit infrmatin cncerning the certificatin, regulatin, and labeling f rganic persnal care prducts, csmetics, and dietary supplements. Specifically, the NOSB recmmends that the fllwing general questins be addressed: 1. Shuld legislatin be adpted and rules written t regulate the labeling f rganic persnal care prducts, csmetics, and dietary supplements? 2. Shuld legislatin be adpted t prhibit the use f the wrd rganic n prducts nt cvered by the Organic Fds Prductin Act f 1990 (OFPA), including persnal care prducts, csmetics, and dietary supplements? USDA-NOP Respnse t NOSB Statement: 1. OFPA and the NOSB charter establish the duties and functins f the NOSB, which d nt include sliciting recmmendatins frm private citizens r rganizatins regarding legislative initiatives. 2. If legislatin t amend OFPA with respect t persnal care prducts and csmetics is enacted, the NOP will enter int ntice and cmment rulemaking t prpse standards fr the prductin, handling, and labeling f these prducts. Until such time, these finished prducts may nt display the USDA seal r be represented as NOP-certified. Only the rganic agricultural ingredients cntained in these prducts may be represented as certified t NOP standards. These prducts may be certified t ther, private standards. 3. Regarding dietary supplements, n determinatin has been made at this time cncerning their labeling under the NOP regulatins.

7 B. NOSB Statement: Sil Amendments, Fertilizers, Manures, and Related Prducts The NOSB recmmends acknwledgement that the labeling f fertilizers, sil amendments, manures, and related prducts is regulated by State authrities. The NOSB further recmmends endrsement f the draft AAPFCO labeling definitin f fr rganic prductin. USDA-NOP Respnse t NOSB Statement: 1. NOP cncurs that the labeling f these prducts is regulated by State authrities. Hwever, the OFPA gives USDA jurisdictin ver the use f the wrd rganic t the extent such prducts may be agricultural prducts. NOP will await the Bard s recmmendatins based n AAPFCO s review f labeling fr these prducts. At its March 2005 meeting, the NOSB tabled its recmmendatin regarding the labeling f these prducts pending further review.

8 C. NOSB Statement: Farm-Raised and Wild-Caught Fish and Seafd The NOSB recmmends the establishment f a new task frce n standards fr wild-caught and farmed-raised fish and seafd. The task frce wuld be structured like the earlier Task Frce n Aquatic Animals, with tw wrking grups -- ne n wild-caught and ne n farmed-raised fish and seafd. These wrking grups will develp recmmendatins fr cnsideratin by the full task frce, which will in turn issue recmmendatins t the NOSB. The new task frce will be directed t cnsider the reprt issued by the previus Task Frce n Aquatic Animals and the subsequent NOSB recmmendatin. Task frce participants will be drawn frm the NOSB and elsewhere. Nn-NOSB participants shuld include fishermen, fish farmers, feed experts, marine cnservatinists, cnsumer representatives, academics, and certifiers. USDA-NOP Respnse t NOSB Statement: 1. NOP cncurs with the frmatin f a task frce with tw wrking grups t cnsider and develp standards t be presented t the NOSB fr its cnsideratin fr farm-raised and wildcaught fish and seafd. 2. NOP published a Federal Register ntice calling fr nminatins t a task frce fr farmraised and wild-caught fish and seafd. The task frce is charged with develping draft standards t prpse t the NOSB fr cnsideratin.

9 D. NOSB Statement: Pet Fd In rder t assess the degree f interest in certificatin and regulatin f pet fd prducts, the NOSB recmmends slicitatin f cmments and infrmatin n a number f issues cncerning the certificatin and labeling f rganic pet fd. Specifically, the NOSB shuld request cmments and infrmatin addressing the fllwing questins: 1. Shuld standards be written and regulatry actin be taken with respect t the labeling f rganic pet fd? 2. Shuld legislatin be adpted t prhibit the use f the wrd rganic n prducts nt certified under OFPA, including pet fd? The NOSB further recmmends that a pet fd task frce be cnvened. If cnvened, the task frce shuld include NOSB members and members f the public representing the rganic trade, the pet fd industry, feed cntrl fficials, academics, and accredited certifying agents. The pet fd task frce shuld: 1) take int cnsideratin infrmatin generated by the request fr cmments; 2) determine which aspects f the existing regulatin pertain t pet fds; 3) if needed, draft amendments t the regulatin fr cnsideratin by the full bard; and 4) identify substances used by pet fd manufacturers fr pssible additin t the Natinal List thrugh the petitin prcess. USDA-NOP Respnse t NOSB Statement: 1. NOP cncurs with the establishment f a pet fd task frce that can address labeling issues fr pet fd and make recmmendatins t the NOSB and NOP fr amending the regulatins t include pet fd as an rganically-prduced prduct. NOP published a Federal Register ntice calling fr nminatins fr a pet fd task frce t develp draft standards n the handling and labeling f pet fd prducts t be prpsed t the NOSB. 2. With regard t legislative prpsals, OFPA and the NOSB charter establish the duties and functins f the NOSB, which d nt include sliciting recmmendatins frm private citizens r rganizatins regarding legislative initiatives.

10 E. NOSB Statement: Mushrms, Apiculture and Hney, Greenhuse Operatins and Prducts, and Hydrpnic Agriculture The NOSB agrees with the NOP psitin that mushrm, apiculture, and greenhuse peratins can be certified as rganic, and that the prducts f such peratins can be labeled rganic and carry the USDA rganic seal. Further, the NOP shuld prceed with regulatry amendments, using recmmendatins submitted by the NOSB. The NOSB pints ut that it adpted, as part f an April 25, 1995, greenhuse recmmendatin, a sectin entitled, Specialized Standards fr Hydrpnic Prductin in Silless Media. The recmmendatin stated, Hydrpnic prductin in silless media t be labeled rganically prduced shall be allwed if all prvisins f the OFPA have been met. Thugh the issue has been discussed, the NOSB has nt submitted a recmmendatin n hydrpnic prductin standards since adptin f the final rule. NOSB recmmends that the Crps Cmmittee place the item n its wrk plan. Rulemaking fr hydrpnic standards shuld nt prceed until the NOSB has submitted a final recmmendatin. USDA-NOP Respnse t NOSB Statement: 1. NOP cncurs with the NOSB and agrees t prceed with additinal rulemaking fr mushrms, apiculture and hney, and greenhuse peratins and their prducts, and nt t prpse hydrpnic standards until the NOSB has submitted a final recmmendatin.

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