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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

establis hing 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
- dimethylhy dantoin CAS Reg. No. 77
- 48
- 5 When read y for use, end
use concentration of all bromine
producing chemicals in solution is not to exceed2 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
- Dimethylhy dantoin as an antimicrobial treatment in solutions containing a diluted end
- use concentration of all bromide
- producing chemicals in the solution not to exceed 90 0 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 full y 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.

Analy tical method is not necessary since 1,3
- dibromo
- 5,5
- dimethylhy dantoi n 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 hy drol yz es to release bromine in the form of h ypobromous acid, which functions as the active antimicrobial agent. Accordingl y, 1,3
- Dibromo
- 5,5
- Dimethylhy dantoin is essentially

a delivery

s ys tem for the h ypobromous aci d. DMDMH is considered a halohy dantoin. The halohydantoins include a group of chemicals composed of several halogenated and non
- halogenated compounds.3

As indicated in the September 2007 Haloh ydantoins RED, generic data have been developed on the breakdo wn products, dimethylhy dantoin (DMH) and ethylmethylhy dantoin (EMH). The primary reason for developing generic data on DMH and EMH rather than the entire haloh ydantoin molecule is that these ring structures represent the persistent component of the haloh y dantoins. A secondary reason for evaluating the haloh ydantoin moieties is that the corrosive properties of the released halogens would limit the amount of chemical that could be administered laboratory animals; thereb y, precluding a meaningful evaluation of the haloh ydantoin 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 relativel y 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 < LD 50 ≤ 500 mg/kg II Acute Dermal Toxicity LD 50 ≥ 2000 mg/kg III Acute Inhalation Toxicity 0.5 mg/liter < LC 50 ≤ 2 mg/liter III Primary Ey e 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

assay s were performed including reverse mutation, mammalian cell gene mutation, chromosome aberration and unscheduled DNA damage. In most assay s, no mutagenicit y was observed; however, two in vitro mammalian cytogenetics assay s 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 27 th presacral vertebrae) in rabbits were observed at a lower does level than that which resulted in material toxicity (decreased bod y weight and food consumption during the dosing period) following treatment. The increase of the 27 th 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..4
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 Dimethylhy dantoin (>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) Dimethylhy dantoin (100% a.i.)

90
- Day Dermal Toxicity
- Rat NOAEL = 390 mg/kg/day (highest dose tested) LOAEL > 390 mg/kg/day 5,5
- Dimethylhy dantoin

5. Chronic toxicity. The combined chronic/carcinogenicit y testing of dimethylhy dantoins in rats showed a decrement in body

weight and body

weight gain in females and increased mortality , particularl y in females. Males showed increase incidences of h yperplasia of submandibular ly

mph nodes, and testicular fibroid vascular degeneration in earl y decedents. Both sexes increased mammary galactoceles in earl y decedents and enlarged pituitary glands. In two chronic toxicity studies conducted in dogs, dimethylhy dantoin 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 ind icate 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 bee n developed, the Halohy dantoins may

be subjected to additional screening and/or testing to better characterized effects related to endocrine disruption. C. Aggregate Exposure5
1. Dietary exposure. The haloh ydantoins are currentl y used for microbial control in water and water s ys tems. 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 add ition, there are five effective Food Contact Substance Notifications (FCNs) for 1,3
- Dibromo
5,5
- Dimethylhy dantoin 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 pesti cide uses proposed in this application. The proposed uses for 1,3
- Dibromo
- 5,5
- Dimethylhy dantoin 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 veget ables. (Note: This use will be covered b y 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 Conta ct 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
- Dimethylhy dantoin will be indoor. When compared to the proposed uses, an existing use (once
- through cooling tower water s ys tem) is expected to have the greatest impact on water, since th e 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) i n 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.6

D. Cumulative Effects The petitioner is not aware of an y 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
- Dimethylhy dantoin is currently approved as a slimicide in the manufacture of food
contact paper and paperboard und er 21 C.F.R. Part 176.300. Additionally , there are currentl y 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 ( IO BW) and in water used for Off

- Line Preprocessing (OL R) 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 IO BW 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 equiva lent 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 b e 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 to7

**FCN No. Intended Use**  **Limitations/Specifications** Effective date October 20, 2011 agent in water used in meat

processing for disinfectin g 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 o ne 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 vegetab les, treatment shall be followed b y a potable water rinse. Albemarle is not aware of an y 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 an y specific safety concerns for infants and children, including an y specific susceptibilities and exposure patterns.
F. International Tolerances. None