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

April 11, 2013

Petition to add 1, 3-Dibromo-5,5-dimethylhydantoin (DBDMH) to Section 205.605(b)

Mac Stone

 Motion to classify 1, 3-Dibromo-5,5-dimethylhydantoin (DBDMH) CAS # 77-48-5 as synthetic 

 

Passed

 As stated in the technical report (line 201) DBDMH is synthetic 

John Foster

Harold Austin

15 0 0 0 0

04/2013 1 of 7 NOSB Recommendation
Rationale Supporting Recommendation (including consistency with OFPA and NOP):

Statement of Recommendation: (Motion # 2)

Committee Vote:

 

Moved: 

SecondĞĚ: 

Yes:EŽ͗ďƐƚĂŝŶ͗ďƐĞŶƚ͗ZĞĐƵƐĞ͗ 

 

 

 

 

3DJHUHYLVHGPD

Failed

Motion to list 1, 3-Dibromo-5,5-dimethylhydantoin (DBDMH) CAS # 77-48-5 on section 205.605(b). 

 

DBDMH has been petitioned for use as an antimicrobial treatment for beef carcasses and parts but fails 

the evaluation criteria of essentiality & availability, as well as compatibility and consistency with organic 

principles. DBDMH is not recognized by other organic programs, and although it has the advantage of 

being less corrosive to concrete and equipment, more cost-effective, and less sensitive to pH variability. 

there are several other materials that are currently in use in organic meat handling. Additionally, there 

were few or no comments from potential users indicating a need for this substance. 

John Foster

Jean Richardson

0 15 0 0 0

04/2013 2 of 7 NOSB Recommendation
National Organic Standards Board

Handling Subcommittee

Petitioned Material Proposal

1,3-dibromo-5, 5-dimethylhydantoin (DBDMH) CAS No. 77-48-5 

January 14, 2013

Summary of Proposed Action:

1,3-Dibromo-5,5-dimethylhydantoin (DBDMH) is an organic compound and is widely used as a disinfectant 

used for drinking water purification ,recreational water treatment, as a bleaching agent in pulp and paper mills, 

and for treating industrial/commercial water cooling systems. 1, 3-Dibromo-5, 5-dimethylhydantoin (DBDMH) is 

an organic compound with the molecular formula C5H6Br2N2O2. In water, DBDMH hydrolyzes to form 

hypobromous acid (HOBr)—a source of bromine and an active antimicrobial agent—and dimethylhydantoin 

(DMH). 

DBDMH has been petitioned for use as an antimicrobial treatment for beef carcasses and parts. The reaction 

of DBDMH mixed with water leads to the production of HOBr, which is the active antimicrobial (see Action of 

the Substance). DBDMH has become a favored antimicrobial in beef and poultry disinfection processes 

because its efficacy is less sensitive to pH than chlorine-based disinfecting agents. DBDMH is also effective in 

protecting food surfaces against the formation of biofilms (i.e., aggregates of microorganisms in which cells

adhere to each other on a surface). 

It is not recognized by other organic programs. There are several other materials that are in current use in 

organic meat handling, this material has the advantage of being less corrosive to concrete and equipment, 

more cost-effective, and less sensitive to pH variability.

Evaluation Criteria 

(Applicability noted for each category; Documentation attached) Criteria Satisfied? (see “B” below)

1. Impact on Humans and Environment ☐ Yes x No ☐ N/A 

2. Essential & Availability Criteria ☐ Yes x No ☐ N/A

3. Compatibility & Consistency ☐ Yes x No ☐ N/A 

4. Commercial Supply is Fragile or Potentially Unavailable ☐ Yes ☐ No x N/A 

as Organic (only for § 205.606)

Substance Fails Criteria Category: [ ] Comments: 

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: Move to classify 1,3-dibromo-5, 5-dimethylhydantoin as synthetic.

Motion by: John Foster Seconded by: Jean Richardson

Yes: 7 No: 0 Absent: 1 Abstain: 0 Recuse: 0

Listing Motion: Move to list 1,3-dibromo-5, 5-dimethylhydantoin as petitioned on section 205.605 (b) of 

the National List 

Motion by: John Foster Seconded by: Harold Austin

Yes: 0 No: 7 Absent: 1 Abstain: 0 Recuse: 0

Crops ☐ ☐

Livestock ☐ ☐

04/2013 3 of 7 NOSB Recommendation
Handling X ☐

No restriction ☐ ☐

Approved by Subcommittee Chair to Transmit to NOSB

John Foster, Subcommittee Chair January 15, 2013

NOSB Evaluation Criteria for Substances Added To the National List

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

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 TR 344+

2. Is there environmental contamination 

during manufacture, use, misuse, or 

disposal? [§6518 m.3]

X TR 344+

3. Is the substance harmful to the 

environment and biodiversity?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

X TR 344+

4. Does the substance contain List 1, 2 or 3 

inerts? [§6517 c (1)(B)(ii); 205.601(m)2]

X TR

5. Is there potential for detrimental chemical 

interaction with other materials used?

[§6518 m.1]

X Not for use in farming

6. Are there adverse biological and 

chemical interactions in agro-ecosystem? 

[§6518 m.5]

X Not for use in farming

7. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518 m.5]

X Not for use in farming

8. Is there a toxic or other adverse action of 

the material or its breakdown products?

[§6518 m.2]

X Not applied in environment, None noted, 

TR 344+

9. Is there undesirable persistence or 

concentration of the material or 

breakdown products in environment?

[§6518 m.2]

X Not applied in environment, None noted, 

TR 344+

10. Is there any harmful effect on human 

health? [§6517 c (1)(A)(i); 6517 c(2)(A)i; 

§6518 m.4]

X DMH may be concerning if 

inappropriately managed. 361-362

11. Is there an adverse effect on human 

health as defined by applicable Federal 

regulations? [205.600 b.3]

X Not for petitioned use 79

12. Is the substance GRAS when used 

according to FDA’s good manufacturing 

practices? [§205.600 b.5]

X TR 216-218

13. Does the substance contain residues of 

heavy metals or other contaminants in 

excess of FDA tolerances? [§205.600 

b.5]

X TR 271. No identified reports.

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable.

04/2013 4 of 7 NOSB Recommendation
NOSB Evaluation Criteria for Substances Added To the National List

Category 2. Is the Substance Essential for Organic Production? Substance: DBDMH

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

regulatory agency; other)

1. Is the substance formulated or manufactured 

by a chemical process? [6502 (21)]

X TR 193+

2. Is the substance formulated or manufactured 

by a process that chemically changes a 

substance extracted from naturally occurring 

plant, animal, or mineral, sources? 

[6502 (21)]

X TR 193

3. Is the substance created by naturally 

occurring biological processes? [6502 (21)]

X TR 193

4. Is there a natural source of the substance? 

[§205.600 b.1]

X TR 208

5. Is there an organic substitute? [§205.600 b.1] X X Alcohol may be produced organically, but 

generally, no, as listed in TR 397-498

6. Is the substance essential for handling of 

organically produced agricultural products? 

[§205.600 b.6]

X Some means of microbial control is 

needed to meet FDA handling standards 

(even pre-FSMA)

7. Is there a wholly natural substitute product?

[§6517 c (1)(A)(ii)]

X TR 193

8. Is the substance used in handling, not 

synthetic, but not organically produced?

[§6517 c (1)(B)(iii)]

X

9. Is there any alternative substances? 

[§6518 m.6]

X X Alcohol, lactic acid, chlorine, ozone, 

hydrogen peroxide, eperoxyacetic acid, 

hot water, and others that may be costly 

due to temp requirements, chemical 

costs. TR 397-498. however, some forms 

of chlorine are less effective and are 

more corrosive than this material. These 

alternatives are also reported by the 

petitioner to be less economically 

feasible.

10. Is there another practice that would make the 

substance unnecessary? [§6518 m.6]

X As per TR 397-404 and other practices 

as noted. 1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable.

04/2013 5 of 7 NOSB Recommendation
NOSB Evaluation Criteria for Substances Added To the National List

Category 3. Is the substance compatible with organic production practices? Substance: 

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

regulatory agency; other)

1. Is the substance compatible with organic 

handling? [§205.600 b.2]

X X Meets some criteria for compatibility but 

not others.

2. Is the substance consistent with organic 

farming and handling? [§6517 c 

(1)(A)(iii); 6517 c (2)(A)(ii)]

X X Meets some criteria for compatibility but 

not others.

3. Is the substance compatible with a 

system of sustainable agriculture? 

[§6518 m.7]

X Not used in farming.

 

4. Is the nutritional quality of the food 

maintained with the substance? 

[§205.600 b.3]

X 

TR 240-253 is noncommittal. Alternatives 

do have negative NQ effects.

5. Is the primary use as a preservative? 

[§205.600 b.4]

X TR 47 and 244. Used as an antimicrobial, 

not a preservative.

6. Is the primary use to recreate or improve 

flavors, colors, textures, or nutritive 

values lost in processing (except when 

required by law, e.g., vitamin D in milk)? 

[205.600 b.4]

X TR 47 and 244. Used as an antimicrobial, 

not a preservative.

7. Is the substance used in production, and 

does it contain an active synthetic 

ingredient in the following categories:

a. copper and sulfur compounds;

X

b. toxins derived from bacteria; X

c. pheromones, soaps, horticultural oils, 

fish emulsions, treated seed, vitamins 

and minerals?

X

d. livestock parasiticides and 

medicines?

X

e. production aids including netting, tree 

wraps and seals, insect traps, sticky 

barriers, row covers, and equipment 

cleaners?

X

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable.

04/2013 6 of 7 NOSB Recommendation
NOSB Evaluation Criteria for Substances Added To the National List

Category 4. Is the commercial supply of an agricultural substance as organic, fragile or potentially 

unavailable? [§6610, 6518, 6519, 205.2, 205.105 (d), 205.600 (c) 205.2, 205.105 (d), 205.600 (c)] 

Substance: Name

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

regulatory agency; other)

1. Is the comparative description provided

as to why the non-organic form of the 

material /substance is necessary for use 

in organic handling? 

X

2. Does the current and historical industry 

information, research, or evidence 

provided explain how or why the material 

/substance cannot be obtained 

organically in the appropriate form to 

fulfill an essential function in a system of 

organic handling? 

X

3. Does the current and historical industry 

information, research, or evidence 

provided explain how or why the material 

/substance cannot be obtained 

organically in the appropriate quality to 

fulfill an essential function in a system of 

organic handling? 

X

4. Does the current and historical industry 

information, research, or evidence 

provided explain how or why the material 

/substance cannot be obtained 

organically in the appropriate quantity to 

fulfill an essential function in a system of 

organic handling?

X

5. Does the industry information provided 

on material / substance non-availability 

as organic, include ( but not limited to) 

the following:

a. Regions of production (including 

factors such as climate and number 

of regions);

X

b. Number of suppliers and amount 

produced;

X

c. Current and historical supplies 

related to weather events such as 

hurricanes, floods, and droughts that 

may temporarily halt production or 

destroy crops or supplies; 

X

d. Trade-related issues such as 

evidence of hoarding, war, trade 

barriers, or civil unrest that may 

temporarily restrict supplies; or

X

e. Are there other issues which may 

present a challenge to a consistent 

supply?

X

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable.

04/2013 7 of 7 NOSB Recommendation