Formal Recommendation 

From: National Organic Standards Board (NOSB) 

To: the National Organic Program (NOP)

Date: 

Subject: 

Chair: 

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action: 

Guidance Statement: 

Other: 

Statement of Recommendation: (Motion # 1) 

 

Rationale Supporting Recommendation (including consistency with OFPA and NOP):

 

Committee Vote:

 

Moved: 

SecondĞĚ: 

Yes:EŽ͗ďƐƚĂŝŶ͗ďƐĞŶƚ͗ZĞĐƵƐĞ͗

 

 

 3DJHUHYLVHGPD

October 16, 2012

Petition to add Rotenone to the National List §205.602 as a Prohibited natural

Barry Flamm

✔ Petition Passed

Passed

 Motion to classify Rotenone as a Natural Substance 

 

 

 

Rotenone is derived from the root of a plant and has long been determined to be non-synthetic. For the 

purposes of 205.602 it is being classified as "Natural".

Jay Feldman

Zea Sonnabend

15 0 0 0 0
Rationale Supporting Recommendation (including consistency with OFPA and NOP):

Statement of Recommendation: (Motion # 2)

Committee Vote:

 

Moved: 

SecondĞĚ: 

Yes:EŽ͗ďƐƚĂŝŶ͗ďƐĞŶƚ͗ZĞĐƵƐĞ͗

 

 

 

 

3DJHUHYLVHGPD

Passed

Motion to add Rotenone to the National List §205.602 as a Prohibited Natural Substance, effective 

January 1, 2016. 

 

Adverse health effects from Rotenone have been well documented in the time since the NOSB reviewed 

botanicals in 1994. Although no longer offered for sale in the USA as a pesticide, rotenone is still in use in 

other countries. While there are compelling reasons to prohibit rotenone, the NOSB is recommending a 

several year period until this takes effect so alternatives can be researched and registered.

Jay Feldman

Zea Sonnabend

15 0 0 0 0
Crops:Rotenone

National Organic Standards Board

Crops Subcommittee

Proposal to Add Rotenone to National List 205.602

as a Prohibited Natural Substance

August 7, 2012

Introduction

The NOSB Crops Subcommittee acknowledges the intent and validity of the portion of the 

Organic Foods Production Act (OFPA) that calls for a Special Review of Botanical Pesticides 

prior to the establishment of the National List [2119(k)(4)]. We wish at this time to re-review the 

botanical pesticide Rotenone and add it to the National List section 205.602 as a Prohibited 

Natural substance.

Background

The NOSB conducted its Special Review of Botanical Pesticides during their meeting that ran 

from October 10 to 14, 1994. As stipulated in OFPA (below) it was before the National List was 

established. The Rotenone portion of the minutes is quoted below (from lines 851 to 874 of the 

official minutes). The references used in the special review in 1994 are cited at the end of this 

recommendation.

Brown reported on the low LD50 of rotenone when tested on rats, its toxicity to fish 

and birds and on no records of fatalities or poisonings in humans. Kinsman reported 

that it is used widely for lice, mange and mites in conventional production. John 

clarified that the Board is reviewing the natural ground root and not synthetic 

preparations or the synthetic extracted form of rotenone. Theuer offered that the halflife of rotenone is long and the required 24 hour withdrawal time may not be long 

enough and that there are many alternatives. Brian Baker stated that rotenone is 

restricted in its applications by private certifiers and that the California Senate 

repealed its registration because of incomplete information and not because of health 

reasons. Merrill Clark requested that the Board take actions to move production away 

from the use of all botanicals by considering a phase out of all botanicals. David 

Haehn spoke to its usefulness in livestock and aquaculture. Brian Baker informed the 

members that rotenone has been debated within the organic community for years

and despite its shortcomings a data gaps, there are no alternatives because of the 

natural/synthetic rule.

Quinn moved and Kinsman seconded to place rotenone on the prohibited natural list. 

VOTE Yes - 1. Opposed - 8. Abstain - 4. Failed. Rotenone is kept off the list of prohibited 

natural substances."

The NOSB and the Secretary have the clear authority to prohibit specific natural substances 

(see below rule sections). Since 1994 a large amount of information has emerged from 

research that showed harmful effects of rotenone on the human system, leading to Parkinsons' 

disease and other health problems. 

Rotenone Regulatory History

In March and April 2006, registrants of rotenone in the U.S. requested voluntarily 

cancellation from the U.S. Environmental Protection Agency (EPA) of all livestock, 
Crops:Rotenone

residential and home owner uses, domestic pet uses, and all other uses except for 

piscicide uses. A data call-in was issued in 2004 requiring a sub-chronic (28-day) 

inhalation neurotoxicity study to further investigate the results of independent studies in 

animals that led to Parkinson’s Disease-like symptoms. At the time the study was 

required, rotenone had registered uses for dust products in agricultural and residential 

settings which were of particular concern for inhalation exposure. However, when all 

agricultural and residential uses, and all food uses were voluntarily cancelled in 2006, 

this requirement was waived. In July 2006, EPA issued its “Report of the Food Quality 

Protection Act (FQPA) Tolerance Reassessment Progress and Risk Management 

Decision (TRED)” in which the agency indicated its intent to revoke the three tolerance 

exemptions for rotenone.

The Registration Eligibility Decision (RED) was completed in 2007. The RED approved 

piscicidal uses granting that additional personal protective equipment (PPE) including 

respiratory protection will be required for all remaining uses. However, EPA states that it 

“cannot quantitatively asses a potentially critical effect (neurotoxicity) at doses to which 

rotenone users could be exposed; therefore, an additional 10x database uncertainty 

factor has been applied.”

Remaining rotenone products are classified as Restricted Use Pesticides (RUP) due to 

acute inhalation, acute oral, and aquatic toxicity. According to EPA, “rotenone is applied 

directly to water to manage fish populations in lakes, ponds, reservoirs, rivers, streams, 

and in aquaculture. The chemical can be applied to an entire water body to achieve a 

“complete kill” or to a portion of a water body to achieve a “partial kill.” Complete kills 

are used to eliminate all fish in the treatment area; partial kills are used to reduce or 

sample fish populations in the treatment area.” (Source: USEPA. 2007. Reregistration 

Eligibility Decision (RED) Document. Office of Pesticide Programs. Washinton DC. 

http://www.epa.gov/oppsrrd1/reregistration/REDs/rotenone_red.pdf)

Updating the National List

While rotenone has been voluntarily cancelled by the manufacturer and its agricultural 

use is phasing out in the United States, a search of the internet in 2012 shows that 

rotenone products are still available in other countries. Because of this, and because 

certifiers, farmers other people involved with organic production are still getting 

questions from the public about rotenone, board action is needed to clarify the situation 

by listing rotenone as a prohibited nonsynthetic.

Therefore, the NOSB has re-reviewed this particular botanical pesticide and 

recommends to the Secretary that it be placed on §205.602 as a prohibited natural 

substance for organic agriculture. The subsequent checklist and list of references 

documents the basis for the recommendation.

Relevant areas in the Rule

OFPA 

Sec 2118 National List (c) Guidelines for Prohibitions or Exemptions –

(2) Prohibition on the use of Specific Natural Substances 

(A) the Secretary determines, in consultation with the Secretary of Health and Human 

Services and the Administrator of the Environmental Protection Agency, that the use of 

such substances 
Crops:Rotenone

(i) would be harmful to human health or the environment; 

Sec 2118 National List (e) Sunset Provision –

No exemptions or prohibition contained in the National List shall be valid unless the 

National Organic Standards Board has reviewed such exemption or prohibition as 

provided in this section within 5 years of such exemption or prohibition being adopted or 

reviewed and the Secretary has renewed such exemption or prohibition.

Sec 2119 National Organic Standards Board (k) Responsibilities of the Board –

(4) Special Review of Botanical Pesticides. The Board shall, prior to the 

establishment of the National List, review all botanical pesticides used in agricultural 

production and consider whether any such botanical pesticides should be included in 

the list of prohibited natural substances." 

(l) Requirements – ....the Board shall –

(1) review available information from the Environmental Protection Agency....., 

concerning the potential for adverse human and environmental effects of substances 

considered for inclusion in the proposed National List.

Discussion

The Crops Subcommittee believes that the data indicating harm to human health precipitated 

the removal of rotenone from the market. Therefore only the checklist for Category 1 is 

presented here based on the NOSB's own literature review conducted in 2012. The negative 

results in category 1 are sufficient for prohibition so that the other categories are not evaluated 

at this time.

Evaluation Criteria:

(Applicability noted for each category; Documentation attached) Criteria Satisfied? 

(see "B" below)

1. Impact on Humans and Environment ܆ Yes ܈ No ܆ N/A 

2. Essential & Availability Criteria ܆ Yes ܈ No ܆ N/A

3. Compatibility & Consistency ܆ Yes ܈ No ܆ N/A 

4. Commercial Supply is Fragile or Potentially Unavailable ܆ Yes ܆ No ܈ N/A 

as Organic (only for § 205.606)

Substance Fails Criteria Category: [1,2,3] 

Subcommittee Comments:

Adverse environmental and health impacts, lack of essentiality, and incompatibility with organic 

principles, as supported by the TR and checklist.

Proposed Annotation (if any):

Basis for annotation: ܆ To meet criteria above ܆ Other regulatory criteria ܆ Citation 

Notes: 

Recommended Subcommittee Action & Vote, including classification recommendation 

(state actual motion):

Classification Motion:
Crops:Rotenone

Rotenone is a natural substance.

Motion by: Harold Austin Second: Barry Flamm

Yes__6___ No__0__ Abstain__0__ Recuse__0__ Absent__2 _

Listing Motion:

To add Rotenone to the National List 205.602 as a Prohibited Natural Substance.

Motion By: Harold Austin Second: Barry Flamm

Yes__6___ No__0__ Abstain__0__ Recuse__0__ Absent__2 _

܆ 1Allowed ܆ Agricultural ܈ Crops

Livestock ܆ Non-synthetic ܈ Prohibited2 ܈

܆ 3Rejected ܆ Synthetic ܆ Handling

No restriction ܆ Commercial unavailable as 

organic

܆ 4Deferred ܆

1

Substance voted to be added as “allowed” on National List to § 205. 601(h) with 

Annotation (if any): 

2

Substance to be added as “prohibited” on National List to § 205 with Annotation (if any): 

Describe why a prohibited substance: 

3

Substance was rejected by vote for amending National List to § 205. Describe why 

material was rejected: 

4

Substance was recommended to be deferred because 

If follow-up needed, who will follow up: 

Approved by Subcommittee Chair to Transmit to NOSB

Jay Feldman, Subcommittee Chair August 7, 2012

NOSB Evaluation Criteria for Substances Added To the National List

Category 1. Adverse impacts on humans or the environment? Substance: Rotenone

Question Yes No N/A1 Documentation (TAP; petition; 

regulatory agency; other)

1. Are there adverse effects on 

environment from manufacture, 

use, or disposal? [§205.600 b.2]

X improper use in agriculture can cause 

the death of fish in nearby water.

2. Is there environmental 

contamination during manufacture, 

use, misuse, or disposal? [§6518 

m.3]

X
Crops:Rotenone

3. Is the substance harmful to the

environment and biodiversity?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

X

4. Does the substance contain List 1, 

2 or 3 inerts? [§6517 c (1)(B)(ii); 

205.601(m)2]

X no registered products in the U.S.

5. Is there potential for detrimental 

chemical interaction with other 

materials used? [§6518 m.1]

X

6. Are there adverse biological and 

chemical interactions in agroecosystem? [§6518 m.5]

X see fish references and comment.

7. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518 m.5]

X unknown for livestock or crops, but

effects on humans may be 

transferrable to livestock.

8. Is there a toxic or other adverse 

action of the material or its 

breakdown products? [§6518 m.2]

X see #10 below

9. Is there undesirable persistence or 

concentration of the material or 

breakdown products in 

environment? [§6518 m.2]

X

10.Is there any harmful effect on 

human health? [§6517 c (1)(A)(i); 

6517 c(2)(A)i; §6518 m.4]

X Rotenone inhibits mitochondrial 

function and has been highly 

correlated with Parkinsons disease 

(Tanner, 2011). Tanner's study is 

highly important because it was based 

on a human population from the 

Farming and Movement Evaluation 

study (FAME), nested in the 

Agricultural Health Study, of 84,740 

private pesticide applicators (mostly 

farmers) (Alavanja, 1996; Blair, 2002) 

Rotenone has also been linked to 

other central nervous system 

pathology (Greene, 2009).

11.Is there an adverse effect on 

human health as defined by 

applicable Federal regulations? 

[205.600 b.3]

X

12.Is the substance GRAS when used 

according to FDA’s good 

manufacturing practices? 

[§205.600 b.5]

X

13.Does the substance contain 

residues of heavy metals or other 

contaminants in excess of FDA 

tolerances? [§205.600 b.5]

X

2012 References Cited:
Crops:Rotenone

Alavanja MC, Sandler DP, McMaster SB, Zahm SH, McDonnell CJ, Lynch CF, et al. 1996. The 

Agricultural Health Study. Environ Health Perspect 104:362–369

Arizona Game and Fish Department 2010. Rotenone - Frequently Asked Questions. 

http://www.azgfd.gov/h_f/documents/ROTENONE%20FAQ%20committee%20final%20report

%20section%201-6-12.pdf

Beyond Pesticides 1987. Safety Source for Pest Management - Beyond Pesticides Least Toxic 

Service Directory – Rotenone. 

http://www.beyondpesticides.org/infoservices/pesticidefactsheets/toxic/ROTENONE.HTM

Blair A, Tarone R, Sandler D, Lynch CF, Rowland A, Wintersteen W, et al. 2002. Reliability of 

reporting on life- style and agricultural factors by a sample of participants in the Agricultural 

Health Study from Iowa. Epidemiology 13(1):94–99.

Center for Disease Control and Prevention 2010 - NIOSH Pocket Guide to Chemical Hazards

Rotenone. http://www.cdc.gov/niosh/npg/npgd0548.html

Chameides, Bill 2011. The Pesticide Rotenone: On the Shelf Instead of Shelved.

http://www.nicholas.duke.edu/thegreengrok/rotenone

Greene JG, Noorian AR, Srinivasan S. 2009. Delayed gastric emptying and enteric nervous 

system dysfunction in the rotenone model of Parkinson’s disease. Exp Neurol 218(1):154–161.

NOSB (National Organic Standards Board) 1994. Minutes from the NOSB meeting in October 

1994 in Rohnert Park, CA. Available at: 

http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5057495

Rotenone Fact Sheet (MSDS) 2008. http://datasheets.scbt.com/sc-203242.pdf

Tamm, Dr. Lucius, et. al. 2000. Use of Rotenone in Organic Agriculture: FiBL Statement -

Noevember 2000 Research Institut of Organic Agriculture, Ackerstrasse, CH-5070 Frick. 

http://www.pmac.net/rotenone.pdf

Tanner CM, Kamel F, Ross GW, Hoppin JA, Goldman SM, et al. 2011. Rotenone, Paraquat, 

and Parkinson’s Disease. Environ Health Perspect 119(6): doi:10.1289/ehp.1002839

US Environmental Protection Agency (EPA) 2010. EPA-HQ-OPP-2005-0494-0066 Rotenone; 

Notice of Receipt of Requests to Voluntarily Cancel Pesticide Registrations. Federal Register

Vol. 75, No. 144, July 28, 2010.

US Environmental Protection Agency (EPA) 2007. EPA 738-R-07-005 Reregistration Eligibility 

Decision for Rotenone. http://www.epa.gov/oppsrrd1/REDs/rotenone_red.pdf

1994 References Used in NOSB Review (Selected)

EXTONET Oregon State University. 1989. Rotenone
Crops:Rotenone

Newsome, Wm.H, and J.B. Shields 1980. Residues of Rotenone and Rotenolone on Lettuce 

and Tomato Fruit after Treatment in the Field with Rotenone Formulations. American 

Chemical Society 0021-8561/80/1428-0722

Worthing, Charles, and R. Hance 1968. The Pesticide Manual, 9th ed. British Crop Protection 

Council.

NOSB (National Organic Standards Board) 1994. Papers used in the Special Review of 

Botanicals at the NOSB meeting in October 1994 in Rohnert Park, CA. Beyond citations here 

there was a TAP review from James Johnson, letter from Bart Hall-Beyer of ATTRA, an 

Agricola Search of citations, MSDS, and several Rotenone Fact Sheets (not well attributed).