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EPA ANTIMICROBIALS DIVISION COMPANY NOTICE OF FILING FOR 

PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER 

EPA Antimicrobials Division contact: Tom Luminello, 703-308-8075, 

Luminello.tom@epa.gov

INSTRUCTIONS: Please utilize this outline in preparing the pesticide petition. In 

cases where the outline element does not apply, please insert “NA-Remove” and 

maintain the outline. Please do not change the margins, font, or format in your 

pesticide petition. Simply replace the instructions that appear in green, i.e., “[insert 

company name],” with the information specific to your action.

TEMPLATE:

Albemarle Corporation

Petition number to be assigned

EPA has received a pesticide petition (1F7914 and 1F7914.02) from Albemarle 

Corporation, 451 Florida Street, Baton Rouge, LA 70801 requesting, pursuant to section 

408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to 

amend 40 CFR part 180

(Options (pick one)

NA – Remove 1. by establishing a tolerance for residues of

2. to amend 40 CFR 180.940(a) to establish a tolerance exemption for active and inert 

ingredients for use in antimicrobial formulations (Food-contact surface sanitizing 

solutions). May be applied to: Food-contact surfaces in public eating places, dairy

processing equipment, and food-processing equipment and utensils

Pesticide Chemical CAS Reg. No. Limits

1,3-dibromo-5,5-

dimethylhydantoin

CAS Reg. No. 

77-48-5

When ready 

for use, enduse 

concentration 

of all 

bromineproducing 

chemicals in 

solution is 

not to exceed 
2

500 parts per 

million 

(ppm) of 

total 

bromine.

3. to establish an exemption from the requirements of a tolerance in 40 CFR 180.____ 

for residues of 1,3-Dibromo-5,5-Dimethylhydantoin in or on all raw agricultural 

commodities, when such residues result from the use of 1,3-Dibromo-5,5-

Dimethylhydantoin as an antimicrobial treatment in solutions containing a diluted 

end-use concentration of all bromide-producing chemicals in the solution not to 

exceed 900 ppm of total bromine.

EPA has determined that the petition contains data and 

information regarding the elements set forth in section 408 

(d)(2) of FDDCA; however, EPA has not fully evaluated 

the sufficiency of the submitted data at this time or whether 

the data supports granting of the petition. Additional data 

may be needed before EPA rules on the petition.

A. Residue Chemistry

1. Plant metabolism. 

NA

2. Analytical method.

Analytical method is not necessary since 1,3-dibromo-5,5-

dimethylhydantoin residues are exempted from the 

requirements of a tolerance.

3. Magnitude of residues.

NA

B. Toxicological Profile

DBDMH is stable in its solid form. It must be diluted in water in an appropriate feeder 

before it can be used in any application. Upon dilution in water, DBDMH rapidly

hydrolyzes to release bromine in the form of hypobromous acid, which functions as the 

active antimicrobial agent. Accordingly, 1,3-Dibromo-5,5-Dimethylhydantoin is 

essentially a delivery system for the hypobromous acid.

DMDMH is considered a halohydantoin. The halohydantoins include a group of 

chemicals composed of several halogenated and non-halogenated compounds. 
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As indicated in the September 2007 Halohydantoins RED, generic data have been 

developed on the breakdown products, dimethylhydantoin (DMH) and 

ethylmethylhydantoin (EMH). The primary reason for developing generic data on DMH 

and EMH rather than the entire halohydantoin molecule is that these ring structures 

represent the persistent component of the halohydantoins. A secondary reason for 

evaluating the halohydantoin moieties is that the corrosive properties of the released 

halogens would limit the amount of chemical that could be administered laboratory

animals; thereby, precluding a meaningful evaluation of the halohydantoin moieties. The 

Agency also determined that data developed on DMH was applicable to EMH and vice 

versa. The basis for this decision was the similarity of the chemical structure of these 

two chemicals and the similarity of results from studies conducted on both the DMH and 

EMH compounds.

Non-acute toxicity testing of dimethylhydantoins (including subchronic, developmental, 

reproductive, and chronic toxicity testing) all show the presence of non-specific toxicity

only at relatively high doses of the test chemical.

1. Acute toxicity. 

Albemarle has submitted acute toxicity data on the undiluted product which contains 

99.4% by weight 1,3-Dibromo-5,5-Dimethylhydantoin. The results of this testing follow:

Test Result Toxicity Category

Acute Oral Toxicity 50 mg/kg < LD50 ≤ 500 mg/kg II

Acute Dermal Toxicity LD50 ≥ 2000 mg/kg III

Acute Inhalation Toxicity 0.5 mg/liter < LC50 ≤ 2 mg/liter III

Primary Eye Irritation Study was waived due to the 

corrosiveness of the test material

II

Primary Dermal Irritation Corrosive I

Dermal Sensitization Not a sensitizer NA

2. Genotoxicity.

A battery of mutagenicity assays were performed including reverse mutation, mammalian 

cell gene mutation, chromosome aberration and unscheduled DNA damage. In most 

assays, no mutagenicity was observed; however, two in vitro mammalian cytogenetics 

assays in Chinese Hamster Ovary cells indicated positive results.

3. Reproductive and developmental toxicity.

Developmental and reproductive toxicity data demonstrate no increase in the 

susceptibility to the toxic effects of DMH with the exception of one study. In this one 

study, fetal and litter effects (increased incidence of 27th presacral vertebrae) in rabbits 

were observed at a lower does level than that which resulted in material toxicity

(decreased body weight and food consumption during the dosing period) following 

treatment. The increase of the 27th presacral vertebrae is a common variation found in 

rabbit development toxicity studies and was not considered an adverse effect. In a 

prenatal developmental toxicity study conducted with EMH, there was not increased 

susceptibility of the fetuses observed..
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4. Subchronic toxicity.

Subchronic testing all show the presence of non-specific toxicity only at relatively high 

dose levels of the test chemical.

Test Result Test Substance

90-Day Oral Toxicity - Rat NOAEL ≥ 1000 mg/kg/day

(highest dose tested)

LOAEL > 1000 mg/kg/day

Dimethylhydantoin 

(>99.5% a.i.)

28-Day Oral Toxicity -

Mouse

NOAEL ≥ 50,000 ppm [males: 

10,057 mg/kg/day, females: 14,972 

mg/kg/day] (highest dose tested)

LOAEL > 50,000 ppm [males: 

10,057 mg/kg/day, females: 14,972 

mg/kg/day] (highest dose tested)

Dimethylhydantoin 

(100% a.i.)

90-Day Dermal Toxicity -

Rat

NOAEL = 390 mg/kg/day (highest 

dose tested)

LOAEL > 390 mg/kg/day

5,5-

Dimethylhydantoin

5. Chronic toxicity.

The combined chronic/carcinogenicity testing of dimethylhydantoins in rats showed a 

decrement in body weight and body weight gain in females and increased mortality, 

particularly in females. Males showed increase incidences of hyperplasia of 

submandibular lymph nodes, and testicular fibroid vascular degeneration in early 

decedents. Both sexes increased mammary galactoceles in early decedents and enlarged 

pituitary glands. In two chronic toxicity studies conducted in dogs, dimethylhydantoin 

produced slight (enlarged pituitary glands) to no toxicity at or above the limit dose of 

1000 mg/kg/day.

6. Animal metabolism.

Available metabolism data indicate that DMH and EMH are excreted unchanged in the 

rat.

7. Metabolite toxicology. 

NA

8. Endocrine disruption. 

When the appropriate screening and/or testing protocols being considered under the 

Agency’s Endocrine Disruptor Screening Program have been developed, the 

Halohydantoins may be subjected to additional screening and/or testing to better 

characterized effects related to endocrine disruption.

C. Aggregate Exposure
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1. Dietary exposure.

The halohydantoins are currently used for microbial control in water and water systems. 

The only current pesticide food use (indirect) for 1,3-Dibromo-5,5-Dimethylhydantoin is 

as a slimicide in the manufacture of food contact paper and paperboard. In addition, 

there are five effective Food Contact Substance Notifications (FCNs) for 1,3-Dibromo5,5-Dimethylhydantoin and one FCN that is the substance of an FDA Acknowledgement 

letter. On August 1, 2011, Albemarle submitted a FCN to address some of the pesticide 

uses proposed in this application.

The proposed uses for 1,3-Dibromo-5,5-Dimethylhydantoin are:

1. To control the growth of spoilage and decay causing non-public health organisms 

in wash and process water and on the surface of processed fruits and vegetables. 

(Note: This use will be covered by the August 1, 2011 Food Contact 

Notification).

2. To control the growth of spoilage and decay causing non-public health organisms 

in wash and process water and on the surface of raw, unprocessed fruits and 

vegetables.

3. For use as a terminal sanitizing rinse on hard surfaces and food processing 

equipment.

4. For use as a continuous sanitizing rinse on conveyor belts.

5. To sanitize shell eggs intended for food. (Note: This use will be covered by the 

August 1, 2011 Food Contact Notification).

i. Food.

Generally, a dietary risk estimate that is less than 100% from the acute or chronic PAD 

does not exceed the Agency’s risk concern. 

None of these proposed food contact scenarios (either direct or indirect) exceed the 

Agency’s level of concern.

ii. Drinking water.

All uses of 1,3-Dibromo-5,5-Dimethylhydantoin will be indoor. When compared to the 

proposed uses, an existing use (once-through cooling tower water system) is expected to 

have the greatest impact on water, since the scenario has the greatest quantity of effluent 

being produced and has the greatest chance of bacterial fouling, needing a pesticide 

application. For this cooling tower use, EPA calculated that the short-term Estimated 

Environmental concentration (EEC) in surface water use was estimated to be 36 ug/L. 

The chronic maximum EEC was determined to be 313 ug./L.

2. Non-dietary exposure. 

Since the proposed uses will be non-residential, the only non-dietary exposures from 

pesticide uses will be occupational (i.e., commercial applicator). Occupational exposures 

are not included under the Federal Food, Drug and Cosmetic Act (FFDCA) in the 

assessment of aggregate exposures for the purposes of establishing tolerances and 

exemptions from tolerances.
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D. Cumulative Effects

The petitioner is not aware of any data regarding adverse cumulative effects from 

exposure of this chemical from its current food uses. 

E. Safety Determination

1. U.S. population. This active ingredient has been approved for pesticide use 

since 1976. As indicated in the Aggregate Exposure section above, 1,3-Dibromo-5,5-

Dimethylhydantoin is currently approved as a slimicide in the manufacture of foodcontact paper and paperboard under 21 C.F.R. Part 176.300. Additionally, there are 

currently six Food Contact Notifications for this material. These include:

FCN No. Intended Use Limitations/Specifications

334 As an antimicrobial in 

chiller water used during 

poultry processing

The Food Contact Substance (FCS) 

will be used at a level not to exceed 

that needed to provide the equivalent 

of 100 parts per million (ppm) of 

available bromine in the chiller water.

357 As an antimicrobial in 

water applied via an 

Inside-Outside Bird 

Washer (IOBW) and in 

water used for Off-Line 

Preprocessing (OLR) of 

poultry.

The FCS will be used at a level not to 

exceed that needed to provide the 

equivalent of 100 parts per million 

(ppm) of available bromine in the 

IOBW and OLR water.

453 For general use an as 

antimicrobial agent in 

water used in poultry

processing for disinfecting 

poultry carcasses and their 

parts and organs

The FCS will be used at a level not to 

exceed that needed to provide the 

equivalent of 100 parts per million 

(ppm) of available bromine (90 mg 

DBDMH/kg water) in poultry process 

water.

775 For use as an antimicrobial 

in water supplied to ice 

machines intended for 

general use in the poultry 

processing industry

The FCS will be used at a level not to 

exceed that needed to provide the 

equivalent of 100 ppm of available 

bromine (corresponding to a maximum 

level of 90 mg DBDMH/kg water) in 

the water supplied to ice machines.

792 For use as an antimicrobial 

in water applied to beef 

hides, carcasses, heads, 

trim, parts, and organs

The FCS will be used at a level not to 

exceed that needed to provide the 

equivalent of 300 parts per million 

(ppm) of available bromine in the 

water.

1102 For use as an antimicrobial The FCS may be used at levels up to 
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FCN No. Intended Use Limitations/Specifications

Effective 

date 

October 20, 

2011

agent in water used in meat 

processing for disinfecting 

pig, goat, and sheep 

carcasses and their parts 

and organs

500 parts per million (ppm) available 

bromine in process water for pork, 

sheep carcasses and their parts and 

organs.

On August 1, 2011, Albemarle submitted one additional FCN. Information on this 

follows:

FCN No. Intended Use Limitations/Specifications

Pending For use as an antimicrobial 

agent in process water for 

fruits and vegetables, and 

as a component of a 

sanitizing solution for shell 

eggs

The FCS will be used at a level not to 

exceed that needed to provide the 

equivalent of 500 parts per million of 

available bromine for shell eggs and 

900 parts per million of available 

bromine for fruits and vegetables. 

When used in water to process fruits 

and vegetables, treatment shall be 

followed by a potable water rinse.

Albemarle is not aware of any detrimental information regarding the use of this active 

ingredient that would bring into question the safety of this chemical. 

2. Infants and children. Albemarle is not aware of any specific safety concerns for 

infants and children, including any specific susceptibilities and exposure patterns.

F. International Tolerances. None