ACCELL CLEAN® DWD 2.0

(6) PRODUCT STORAGE [§ 300.915(a)(6)]
1. Maximum storage temperature (e.g., ^oF and/or ^oC): 130^oF
2. Minimum storage temperature (e.g., ^oF and/or ^oC): 15^oF
3. Optimum storage temperature (e.g., ^oF and/or ^oC): 30^oF to 120^oF
4. Humidity (e.g., g/kg): Relative humidity will have no impact on a sealed container of the product.
Optimal humidity for chemical storage is between 30% to 95% relative humidity. Relative humidity would only have an effect on the product if the liquid were exposed to the environment for more than 12 hours.

• Maximum humidity: should not exceed 95%
• Minimum humidity: should not be lower than 15%
• Optimal humidity: 75%

5. Other relevant conditions for product storage: The ambient air temperature around the liquid has little effect on the product unless the liquid reaches these minimum or maximum temperatures beyond 12 consecutive hours.
6. Description of the consequences to performance if product is not stored within these limits: If the product were exposed to extreme heat (above 150^oF) or extreme cold (below -20^oF) the product may exhibit phase separation. In some cases, the product can be reblended or re-agitated to re-establish a homogeneous solution. Advanced BioCatalytics can provide technical support in such an extreme instance to advise and assist on product performance evaluation and the re-blending process if deemed feasible.

(7) SHELF LIFE STORAGE CONDITIONS [§ 300.915(a)(7)]
The product should have a minimum shelf life of 10 years and potentially much longer as long as the original packaging remains sealed. Documentation for this determination was provided by the submitter on October 18, 2024. Advanced BioCatalytics offers lab testing of existing inventory and recertification of material. The testing and recertification will be conducted for a fee. The testing and recertification of the material will require that an aliquot of at least 250ml be sent to the address in (a)(1) of this bulletin. Orders may be submitted by email to: Advanced BioCatalytics Order ([email protected]) with the SUBJECT: "Testing and Recertification for ACCELL CLEAN^® DWD 2.0"

(8) PRODUCT LABEL [§ 300.915(a)(8)] A sample product label for all name(s), brand(s), and/or trademark(s) under which the product is to be sold that includes manufacture and expiration dates, and conditions for storage: Accell Clean^® DWD 2.0

(9) PRODUCT CATEGORY AND PROCESSES [300.915(a)(9)]
Accell Clean^® DWD 2.0 Deep Water Dispersant is comprised of a combination of surfactants, solvent and a bio-based Yeast Extract Hydrolysate from Saccharomyces cerevisiae that create a proper hydrophilic-lipophilic balance (HLB) that disperses the spilled oil rather than emulsifying the spilled oil. The dispersed oil is comprised of fine oil droplets that are much more bioavailable for degradation than the coarse oil droplets or any emulsified oil. The yeast extract functions as a surfactant synergist by reducing the interfacial tension and critical micelle concentration. This function yields greater surfactancy properties at lower concentrations. Additionally, the yeast extract affects aerobic bacteria to increase their ability to uptake organic material at a faster pace than would be observed for the surfactants alone. The solvent also assists in reducing interfacial tension and dispersing the spilled oil into the water column and remaining dispersed for an increased rate of degradation.

(10) RECOMMENDED PRODUCT USE PROCEDURES [§ 300.915(a)(10)]

1. Application Method:

• Aerial application: Aircrafts provide the most rapid method of applying dispersants to an oil spill and a variety of aircraft can be used for spraying. For aerial spraying, Accell Clean^® DWD 2.0 is applied undiluted. Typically, application altitudes of 30 to 50 feet are recommended, although higher the altitudes may be effective under certain conditions. Actual effective altitudes will depend on the application equipment, weather, and aircraft. Careful selection of spray nozzles is critical to achieve the desired dose levels, since the droplet size must be controlled. A quarter-inch open pipe may be all that is necessary if the aircraft travels at 120 mph (104 knots) or, more, since the air shear at these speeds will be sufficient to break the dispersant into the proper sized droplets. Agricultural spray delivery systems may not be suitable because too fine spray and too little delivery of Accell Clean^® DWD 2.0 to affected area. Companies that are considering the use for this product from aircraft or vessels should consult the American Petroleum Institute’s Technical Report 1148, Aerial and Vessel Dispersant Preparedness; and for subsea use, American Petroleum Institute's Technical Report 4791, Industry Guidelines on Requesting Regulatory Concurrence for Subsea dispersant Use, which both describe the process and application of dispersants in a marine environment.
• Boat application: Accell Clean^® DWD 2.0 may also be applied from boats equipped with spray booms mounted ahead of the bow wake or as far forward as possible. The most effective method of application from a boat is to apply Accell Clean^® DWD 2.0 using a low-volume, low-pressure pump so Accell Clean^® DWD 2.0 can be applied undiluted. Accell Clean^® DWD 2.0 should not be fogged or atomized. Natural wave or boat wake action usually provides adequate mixing energy to disperse the oil. Application at sub-freezing temperatures may require a larger nozzle, supply lines, and orifices due to higher product viscosity.
• Subsea application: Accell Clean^® DWD 2.0 may also be applied subsurface at the well head using submarine equipment.

2. Concentration / Application Rate: A treatment rate of about 5 gallons per acre, or a dispersant to oil ratio of 1:20 is optimal for aerial or vessel application, however, application rates of 1:10-1:50 can be used based on the type of oil, degree of weathering, temperatures, and thickness of the slick. For subsurface application a 1:100 dispersant to oil ratio use has been proven to be an effective ratio.
3. Conditions for Use: Accell Clean^® DWD 2.0 can be used in salt water, brackish waters, open ocean or subsurface ocean waters with limitations as specified by the Federal On-Scene Coordinator in consultation with the NOAA Scientific Support Coordinator.

(11) ENVIRONMENTAL FATE OF COMPONENTS [§ 300.915(a)(11)]
The submitter provided available information on environmental fate, including any known measured data, methodologies, and supporting documentation, on the persistence, bioconcentration factor, bioaccumulation factor, and biodegradability of the product and all of its components in the environment on October 18, 2024.

(12) PHYSICAL/CHEMICAL PROPERTIES [§ 300.915(a)(12)]

(13) IDENTIFICATION AND CONCENTRATION OF PRODUCT COMPONENTS [§ 300.915(a)(13)]
Under § 300.950, you may only claim as Proprietary Business Information (PBI) the concentration, the maximum, minimum, and average weight percent; and the units of each component of the total formulation as identified in § 300.915(a)(13) and (14) and as applicable. All other product information submitted to EPA as required under § 300.915 and § 300.955 will be available for public disclosure upon submission, without further notice to the submitter.

(14) MICROORGANISMS, ENZYMES AND/OR NUTRIENTS [§ 300.915(a)(14)]
Accell Clean^® DWD 2.0 contains no microorganisms, enzymes or nutrients. Although yeast species are used during a proprietary fermentation process to create the hydrolysate, the yeast microorganism itself is subject to thermal lysis which is the breakdown of the cell membrane through a heat shock process. The material is further processed using a combination of centrifugation, filtration, and sterilization methods to remove any remaining solid material. The result is the hydrolysate material, also referred to as yeast metabolite, but without any living microorganisms present. Through HPLC (high precision liquid chromatography) analysis we have also determined there are no enzymes present in the material. There are short chain proteins and amino acids which function as a surfactant synergist or co-surfactant making micelles larger and increasing the functionality of the dispersant. One may characterize short chain proteins as "nutrients," however, that is not the intended purpose of this material.

(15) DATA, METHODOLOGY AND SUPPORTING DOCUMENTATION FOR LEVELS OF THE FOLLOWING [§ 300.915(a)(15)]:

(16) PROHIBITED AGENT CERTIFICATION [§ 300.915(a)(16)]
Certification including data, methodology and supporting documentation indicating that product does not contain any prohibited agents identified in § 300.910(e) provided by submitter October 18, 2024.

(17) LABORATORY INFORMATION [§ 300.915(a)(17)]
Information about the accredited laboratory that conducted the required tests, including: (i)Name of the laboratory, address, contact, name, email, and phone number; and (ii) the national and/or international accreditations held by the laboratory that are applicable to test(s) performed were provided by the submitter on October 18, 2024.

(18) LABORATORY TEST DATA AND REPORTS [§ 300.915(a)(18)]
All test data and calculations were provided by the submitter on October 18, 2024.

(19) PRODUCTION VOLUMES [§ 300.915(a)(19)]
Annual production volume: 1,560,000 gallons
Average amount that could be produced in a day: 3,571 gallons
Maximum amount that could be produced in a day: 4,286 gallons
Time frame needed to reach that maximum production rate in days: The ramp up time to reach maximum daily production is two months or 60 days.

(20) DESIGN FOR THE ENVIRONMENT (now Safer Choice) [§ 300.915(a)(20)]
Not provided.

DISPERSANT EFFICACY TEST AND LISTING CRITERIA [§ 300.915(b)(1)]
Listing Criteria: Dispersant must demonstrate for each temperature a Dispersant Effectiveness (DE) at the 95% lower confidence level (LCL95) greater than or equal to:

• ≥70% for Strategic Petroleum Reserve Bryan Mound test oil at 5^oC; and
• ≥75% for Strategic Petroleum Reserve Bryan Mound test oil at 25^oC.

DISPERSANT TOXICITY TESTS AND LISTING CRITERIA [§ 300.915(b)(2)]
Listing Criteria: Dispersant tested alone must demonstrate:

• For acute toxicity a median lethal concentration for 50% of the test species (LC50) at the lower 95% confidence interval greater than 10 ppm.
• For developmental toxicity the inhibition concentration for 50% of the test species (IC50) at the lower 95% confidence interval greater than 1 ppm; and
• For sub-chronic toxicity the No Observed Effect Concentration (NOEC) greater than 1 ppm.