United States Chemical Safety February 2012 Environmental Protection and Pollution Prevention Agency (7510P)



# Glycine, N-(Hydroxymethyl)-Monosodium Salt (SHMG) Registration Review: Final Work Plan

February 2012Docket Number : EPA-HQ-OPP-2011-0615 www.regulations.gov



### Glycine, N-(Hydroxymethyl)-Monosodium Salt (SHMG)

. Registration Review: Final Work Plan

February 2012

Case 

## # 5030

Approved By:

o an Harrigan

- F relly Director, Antimicrobials Division

Date :



## I I

20[14 "Docket Number: EPA-HQ-OPP-2011-0615 www.regulations.gov

3 of 14 SHMG Registration Review Team

Human Health & Environmental Effects William Hazel Srinivas Gowda

Risk Management Rebecca von dem Hagen Lance Wormell

Office of General Counsel Philip Ross

________________________________________ Supporting documents for the Glycine, N-(Hydro xymethyl)-Monosodium Salt Case may be found in the registration review docket EPA-HQ-OPP-2011-0615 located on the internet at www.regulations.gov

.Docket Number: EPA-HQ-OPP-2011-0615 www.regulations.gov

4 of 14 Introduction

This is the Final Work Plan (FWP) of the Environmental Protection Agency (EPA or “the Agency”) for the registration review of Glyc ine, N-(hydroxymethyl)-monosodium salt (SHMG) (Case 5030). The work plan includes the expected registration review timeline. The work plan also addresses public comments received concer ning the Preliminary Work Plan (PWP) in the Summary Document which was posted in th e Glycine, N-(hydroxymethyl)-monosodium salt registration review docket, and any other comments concerning the initial docket postings. The Summary Document provided information on wh at EPA knows about the pesticide and what additional risk analyses and da ta or information the Agency believes are needed to make a registration review decision.

The Agency is implementing the registration revi ew program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and will review each registered pesticide every 15 years to determine whether it continues to meet th e FIFRA standard for registration. Changes in science, public policy an d pesticide use practices will occur over time. The registration review program is intended to ma ke sure that, as the ability to assess risk evolves and as policies and practi ces change, all registered pestic ides continue to meet that statutory standard. The public pha se of registration review begins when the initial docket is opened for each case. Information on this program is provided at: http://www.epa.gov/oppsrrd1/ registration_review/.

The first product containing Glycine, N-( hydroxymethyl)-, monosodium salt (PC Code 128972), also known as sodium hydroxymethyl glycinate or SHMG, as an activ e ingredient was registered in the United States in 1997. Currently, there is only one product containing SHMG registered with EPA. This product, Suttocide A 50% Soluti on (EPA Reg. No. 57978-4), is a biocidal agent registered for use to inhibit the gr owth of bacteria and fungi. It is registered for use as a material preservative in liquid soaps, fabric cleani ng and care products, water based cleaning products, waterborne coatings and polishes, water base d adhesives, printing supplies, and textile emulsions. SHMG can also be used as a preser vative in cosmetics. Cosmetic uses are not regulated by EPA.

SHMG’s mechanism of antimicrobi al action appears to be largel y or wholly vi a release of formaldehyde (HCHO). In a 2002 “Opinion,” The EU’s Scientific Committee on Cosmetic and Non-food Products Intended for Consumers (SCC NFP) indicated that, in aqueous solution, SHMG is rapidly decomposed to formaldehyde and sodium glycinate. Glycine/sodium glycinate is the simplest amino acid, is naturally occurring in humans, is one of the basic 20 components of protein, and is not of toxicol ogical concern. Formaldehyde is being evaluated as an active ingredient separately under regi stration review Case 0556. EPA anticipates the need to require additional data on SHMG for use in assessing risk from the parent compound (i.e., SHMG) and/or formaldehyde.

SHMG is not registered for use in products that may come in direct contact with food. No tolerance or tolerance exemption has been establis hed in food as a result of use as a direct or indirect food additive, as an active i ngredient, or as an inert ingredient.Docket Number: EPA-HQ-OPP-2011-0615 www.regulations.gov

5 of 14 The SHMG Preliminary Work Plan (PWP) wa s published on September 20, 2011 and the 60-day comment period ended on November 29, 2011. EPA di d not complete a rere gistration eligibility decision (RED) for SHMG because the first pestic ide product containing SHMG was registered after November 1, 1984. Documents associated w ith the registration review of SHMG can be viewed at www.regulations.gov in docket EPA-HQ-OPP-2011-0615.

Comments Received on the Preliminary Work Plan

The Agency received one comment during the p ublic comment period on the initial docket, described below. In the PWP, the Agency soli cited comments on specific topics: environmental justice, water body impairment, trade irritants, an d structure activity relati onships. No comments were received during the public comme nt period concerning these issues.

Comment: “We encourage the registrant to pursu e possible waivers for the 90-day dermal toxicity study, the 90-day i nhalation toxicity study, and the reproduction and fertility effects study (multigeneration). The Human H ealth Scoping Document indicates that the reproduction and fertility effects study may be waived but the Summary Document does not. We also wish to highlight the follo wing data that can be found in an MSDS.

Reproductive/Developmental Toxicity: Oral; Rat; 150, 300 or 450 mg/kg/day for 9 days; not teratogenic or embryotoxic (100% sodium hydroxymethylglycinate).

If this study and the waiver option are deemed unacceptable then we recommend the use of OECD TG 443 Extended One-Generation Reproductive Toxicity Study (EOGRTS), which uses about half the number of animal s as the traditional Re production and Fertility Effects guideline. The test guideline is currently availa ble on the OCED website.”

Response: As noted in the Summary of Product Chemistry, Environmental Fate, and Ecotoxicity Data for the Glycine, N-(h ydroxymethyl)-monosodium salt Registration Review Decision Document , “if the recommended environmen tal fate studies demonstrate to EPA’s satisfaction that SHMG rapidly and completely degrades to HCHO and glycine, the subchronic dermal and inhalation toxicity studies may be waived. Similarly, if the recommended environmental fate studies dem onstrate to EPA’s satisfaction that SHMG rapidly and completely degrades to HCHO and glycine such that residues of concern will not be expected to contaminate drinking wate r, the two-generation reproductive toxicity study may be waived.” A footnote explai ning the option of a waiver for the twogeneration reproductive toxicity study was inadvertently omitted from the Preliminary Work Plan and has been included in this FWP.

In addition, the Agency encourages the re gistrants to submit relevant studies and applicable waivers in response to the data call-in associated w ith this registration review. At that time, the Agency will review the in formation to determine if the reproductive toxicity data requirement is adequately met or can be waived. The Agency agrees with PCRM that an extended one-generation re productive and fertility effects study will provide the Agency with sufficient inform ation to support the human health risk assessment planned for the SHMG registra tion review. The Agency will accept aDocket Number: EPA-HQ-OPP-2011-0615 www.regulations.gov

6 of 14 multigeneration or an extended one-generati on reproductive and fertility effects study. The “Anticipated Human Health Data Needs” section in this FWP has been updated to reflect this change.

The comment received during th e initial public comment period resulted in the changes described above. The comments did not otherwise affect the data needs, work plan and timeline described in the PWP. Further, this docume nt makes final the work plan for the SHMG registration review process.

Risk Assessments and Anticipated Data Needs

The Agency anticipates the need to conduct a comprehensive ecological risk assessment, including an endangered species risk assessmen t, for all uses of SHMG. The Agency also anticipates the need to conduct a human health risk assessment. The Agency anticipates needing additional data for use in conducting the registration review for SHMG.

Ecological Risk Assessment Status and Data Needs

 No ecological risk assessment has been performed for SHMG.

 The Agency anticipates the need to require th e following ecological effects data for use in the registration review of SHMG.

850.5400 -- Algal Toxicity Tier II us ing freshwater green alga, Selenastrum capricornutum

 The Agency anticipates the need to require the following environmental fate data for use in the registration review of SHMG.

835.1110 -- Activated Sludge Sorption Isotherm 835.2120 -- Hydrolysis 835.2240 -- Photodegradation in Water 850.6800 -- Modified Activated Sludge , Respiration Inhibition Test 1 835.3110 -- Ready Biodegradability 1
835.3220 -- Porous Pot Test 1 835.3240 -- Simulation Test – Aerobic Sewage Treatment: A. Activated Sludge Units 1 835.3280 -- Simulation Tests to Assess the Biodeg radability of Chemicals Discharged to Wastewater 1

1 The results of the Activated Sludge Respiration Inhib ition Test (ASRI) expected to be required will determine which of these three biodegradation tests would be anticipated to be required. If the ASRI test EC 50 is less than or equal to 20 mg/L, then either the Biodegradation in Activated Sludge Study or Simulation Test – Aerobic Sewage Treatment: A. Activated Sludge Units or the Porous Pot Test would be anticipated to be required. If the ASRI test EC 50 is greater than 20 mg/L, then the applicant would choose to conduct either: (i) Ready Biodegradability or (ii) a) Biodegradation in Activated Sludge or b) Simulation Test – Aerobic Sewage Treatment: A. Activated Sludge Units or c) the Porous Pot Test. If the Ready Biodegradability study is conducted and passes, then no further testing would be expected to be required. If, however, the an timicrobial fails the Ready Biodegradability study, then the Biodegradation in Activated Sludge or Simulation Test – Aerobic Sewage Treatment: A. Activated Sludge Units, or the Porous Pot study would be expected to be required.Docket Number: EPA-HQ-OPP-2011-0615 www.regulations.gov

7 of 14  For more information, please refer to Summary of Product Chemistry, Environmental Fate, and Ecotoxicity Data for the Gl ycine, N-(hydroxymethyl)-monosodium salt Registration Review Decision Document , located in the docket.

Human Health Risk Assessment Status and Data Needs

 The Agency did not perform a quantitative human health risk assessment at the time of the initial registration based on the low likelihood of exposur e and the absence of adverse systemic effects in available toxicity studies.

Dietary Assessment

 Dietary (food) exposure is not expected becau se the SHMG product cannot be used to preserve materials that may come in direct contact with food.

 Due to the potential for dietary (drinking wate r) exposure from the ma terial preservative use of SHMG, the Agency intends to determ ine the need for a drinking water assessment upon the submission and review of the environmen tal fate data anticipated to be needed for this registration review.

 The Agency did not complete a dietary risk assessment for th e initial registration of the only SHMG product.

Tolerances and Intern ational Harmonization

 SHMG is not registered for use in products that may come in direct contact with food. No tolerance or tolerance exemption has been establ ished in food as a result of use as a direct or indirect food additive, as an active ingredient, or as an inert ingredient.

Occupational and Residen tial Assessment and Risk

 To determine the conditions under which resi dential and occupationa l exposure to the parent compound and/or formal dehyde are likely to occur from the use of SHMG as a preservative, the Agency anticipates re quiring detailed use and other information, presented below, to clarify the conditions, ra tes, and magnitude of formaldehyde release from SHMG under various conditions and in various materials.

 The Agency anticipates conducti ng residential risk assessmen ts on adult applicator/user dermal and inhalation exposure and postappl ication dermal and inhalation exposure to adults and children.

 The Agency anticipates conducting occupationa l risk assessments on handler dermal and inhalation exposure during direct -pour activities, handler dermal and inhalation exposure to SHMG and inhalation risk to formalde hyde resulting from use or application of preserved water-based materials, and bystande r inhalation risk to formaldehyde resulting from preservation of wa ter-based materials.Docket Number: EPA-HQ-OPP-2011-0615 www.regulations.gov

8 of 14  The Agency has not previously conducted qua ntitative occupational and residential risk assessments for SHMG.

Aggregate and Cumulative Exposure and Risk

 In examining aggregate exposure, EPA take s into account the available and reliable information concerning exposures to resi dues in food and drinking water, and nonoccupational pesticide exposures. If the result s of the environmental fate data indicate that a drinking water assessment is necessary, then the Agency anticipates the need to conduct an aggregate assessment for residentia l and dietary exposure to SHMG. In the absence of the environmental fate data, the Agency would assume that dietary exposure occurs and, therefore, would anticipate the need to perform an aggregate risk assessment. The Agency anticipates performing an a ggregate assessment for all non-occupational sources of formaldehyde.

 The Agency has not previously conducted an aggregate risk assessment for SHMG.

 EPA does not have, at this time, available data to determine whether SHMG has a common mechanism of toxicity w ith other substances or how to include this pesticide in a cumulative risk assessment.

 For the purposes of this Registration Revi ew, EPA has assumed that SHMG does not have a common mechanism of toxicity with other substances when used as an antimicrobial as registered.

Human Health Data Needs

 The Agency anticipates the need to require the following additional human health data for use in the registra tion review of SHMG.

870.3250 -- 90-day dermal toxicity 2 870.3465 -- 90-day inhalati on toxicity (rat) 2 870.3800 -- Reproduction and fertility effects (multigeneration or extended onegeneration) 3 - rat 875.1700 -- Product use information 875.2700 -- Product use information 875.2800 -- Description of human activity 875.1100 -- Dermal outdoor exposure

2 If the environmental fate studies that are expected to be required demonstrate that SHMG rapidly and completely degrades to formaldehyde and glycine, registrants may request that EPA waive the requirement for Guideline 870.3250 and Guideline 870.3465.
3 If the environmental fate studies that are expected to be required demonstrate that SHMG rapidly and completely degrades to formaldehyde and glycine such that residues of concern will not be expected to contaminate drinking water, registrants may request that EPA waive the requirem ent for Guideline 870.3800. If the registrant elects to perform an extended one-generation stud y, a protocol will need to be subm itted for review and approval by the Agency prior to initiation.Docket Number: EPA-HQ-OPP-2011-0615 www.regulations.gov

9 of 14 875.1200 -- Dermal indoor exposure 875.1300 -- Inhalation outdoor exposure 4 875.1400 -- Inhalation indoor exposure 4 875.1600 -- Application exposure data reporting and calculations 875.2900 -- Data reporti ng and calculations

 The Agency does not anticipate the need to require additional toxicity data on formaldehyde through the SH MG registration review.

 Past SHMG risk assessments have relied in part on two human studies that involved intentional exposure to SHMG (both studies are combined in a single data volume, MRID 43514301). In the course of registration revi ew, EPA will reconsider these studies, as well as consider any other research involving intentional exposure of human subjects to SHMG brought to its attention. If EPA dete rmines that the two previously-identified intentional exposure human studies (or any ad ditional intentional exposure human studies brought to EPA’s attention) are sufficiently soun d from a scientific pe rspective to warrant inclusion in future risk assessments, EPA w ill consider the ethical acceptability of the studies. Before reaching a final decision to rely on any such studies, EPA will ensure that all applicable regulatory requirements ar e met, including but not limited to the requirements for EPA ethics re view and Human Studies Review Board review of certain research involving intentional exposure of human subjects.

 For more information, please refer to Summary of Product Chemistry, Environmental Fate, and Ecotoxicity Data for the Gl ycine, N-(hydroxymethyl)-monosodium salt Registration Review Decision Document , located in the docket.

Product Chemistry Data Needs

 The Agency does not anticipate the need to require additional product chemistry data for the registration review of SHMG at this time.

 For more information, please refer to Summary of Product Chemistry, Environmental Fate, and Ecotoxicity Data for the Gl ycine, N-(hydroxymethyl)-monosodium salt Registration Review Decision Document , located in the docket.

4 If the inhalation indoor (875.1400) and outdoor (875.1300) exposure data are required as anticipated, the DCI would provide that the registrant may elect to submit small chamber studies demonstrating formaldehyde air emission rates and any available Industrial Hygiene air sampling data (explained below). Based on the results of the small chamber studies, the Agency may de termine that the inhalation indoor and outdoor exposure data expected to be required would no longer be necessary. The DCI would provide that, if the registrant elects to perform such small chamber studies , a protocol will need to be submitted for review and approval by the Agency prior to initiation. The Agency also anticipates the need to require that available Industrial Hygiene air sampling data from commercial facilities manufacturing, storing, or using large quantities of bulk or end-products made from preserved materials be submitted, especially for paper mills, facilities manufacturing preserved liquid materials, and other manufacturing facilities where SHMG is used as part of the inhalation indoor (875.1400) and outdoor (875.1300) exposure studies expect ed to be required.Docket Number: EPA-HQ-OPP-2011-0615 www.regulations.gov

10 of 14 Incidents:

Ecological:

 No SHMG ecological incidents have been repo rted in the Agency’s Ecological Incident Information System (EIIS).

Human Health:

 No SHMG human poisoning incidents have been reported in the OPP incident database.

Endangered Species

The Agency has not conducted a risk assessmen t that supports a complete endangered species determination for SHMG. The ecological risk a ssessment planned during registration review will allow the Agency to determine whether SHMG’s use has 'no effect' or 'may affect' federally listed threatened or endangered sp ecies (listed species) or their de signated critical habitats. When an assessment concludes that a pesticide’s use 'm ay affect' a listed species or its designated critical habitat, the Agency will consult with th e U.S. Fish and Wildlife Service and/or National Marine Fisheries Services (the Services), as appropriate.

Endocrine Disruptor Screening Program

As required by FIFRA and FFDCA, EPA reviews num erous studies to asse ss potential adverse outcomes from exposure to chemicals. Collectiv ely, these studies includ e acute, subchronic and chronic toxicity, including asse ssments of carcinogenicity, ne urotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include e ndpoints which may be susceptible to endocrine influe nce, including effects on endocri ne target organ histopathology, organ weights, estrus cyclicity, sexual maturatio n, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and chronic studies that assess gr owth, developmental and reprod uctive effects in different taxonomic groups. A human health risk assessment identifying the most sensitive endpoints has not been conducted for the SHMG Case. As required by FFDCA section 408(p), SHMG is subject to the endocrine screeni ng part of the Endocrine Disrup tor Screening Program (EDSP).

EPA has developed the EDSP to determine whet her certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally occurring estrogen, or ot her such endocrine effect s as the Administrator may designate.” The EDSP employs a two-tiered approach to making th e statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estrog en, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go th rough Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stag e of the EDSP where EPA will determine which, if any, of th e Tier 2 tests are necessary base d on the available data. Tier 2 testing is designed to identify a ny adverse endocrine-related eff ects caused by the substance, and establish a dose-response relationship between the dose and the E, A, or T effect.Docket Number: EPA-HQ-OPP-2011-0615 www.regulations.gov

11 of 14 Under FFDCA section 408(p), the Agency must scre en all pesticide chemicals. Between October 2009 and February 2010, EPA issued test orders/dat a call-ins for the firs t group of 67 chemicals, which contains 58 pesticide activ e ingredients and 9 inert ingred ients. SHMG is not among the group of 58 pesticide active ingredients on the in itial list to be screened under the EDSP. Accordingly, as part of registration review, EPA will issue future EDSP orders/data call-ins, requiring the submission of EDSP screening assa ys for SHMG. For further information on the status of the EDSP, the policies and procedures, the list of 67 chemicals, future lists, the test guidelines and the Tier 1 scr eening battery, please visit our website: http://www.epa.gov/endo/.Docket Number: EPA-HQ-OPP-2011-0615 www.regulations.gov

12 of 14 Timeline

EPA has created the following estimated timelin e for the completion of the SHMG registration review:

Activities Estimated Month/Year Phase 1: Opening the docket Open Public Comment Period for Docket September 2011- Completed Close Public Comment Period for Docket November 2011- Completed Phase 2: Case Development Develop Final Work Plan (FWP) February 2012- Completed Issue DCI March 2013 Data Submission March 2015 Open Public Comment Period for Prelim inary Risk Assessments September 2016
Close Public Comment Period for Prelim inary Risk Assessments October 2016 Phase 3: Registration Review Decision Open Public Comment Period for Propos ed Reg. Review Decision March 2017 Close Public Comment Period for Pro posed Reg. Review Decision May 2017 Final Decision and Begin Post-Decision Follow-up 2017 Total (years) 6

Next Steps

A DCI will be developed regarding the data ne eds listed under the “Risk Assessments and Data Needs” section of this document. The Agency expects to issue the DCI in March 2013. Human health and ecological risk assessments w ill be conducted for all uses of SHMG.Docket Number: EPA-HQ-OPP-2011-0615 www.regulations.gov

13 of 14 Summary of Anticipated Data Requirements – SHMG

The table below summarizes anticipated data needs for the SHMG Case in this document (Final Work Plan), Summary of Product Chemistry, Environmen tal Fate, and Ecotoxicity Data for the Glycine, N-(hydroxymethyl)-monosodium salt Registration Review Decision Document. , and Glycine, N-(hydroxymethyl)-, monosodium salt. Human Health Scoping Document for the Registration Review.

Guideline Number Anticipated Data Requirement Test Material Estimated Timeframe (Measured in months from DCI Receipt)
870.3250 90-day dermal toxicity 5 TGAI 24
870.3800 90-day inhalation toxicity (rat) 5 TGAI 24

870.3800 Reproduction and fertility effects (multigeneration) - rat 6 TGAI 24

875.1700 Product use information TGAI 12

875.2700 Product use information TGAI 12
875.2800 Description of human activity TGAI 12
875.1100 Dermal outdoor exposure TGAI 24
875.1200 Dermal indoor exposure TGAI 24
875.1300 Inhalation outdoor exposure 7 TGAI 24
875.1400 Inhalation indoor exposure 7 TGAI 24

5 If the environmental fate studies that are expected to be required demonstrate that SHMG rapidly and completely degrades to formaldehyde and glycine, registrants may request that EPA waive the requirement for Guideline 870.3250 and Guideline 870.3465.
6 If the environmental fate studies that are expected to be required demonstrate that SHMG rapidly and completely degrades to formaldehyde and glycine such that residues of concern will not be expected to contaminate drinking water, registrants may request that EPA waive the requirem ent for Guideline 870.3800. If the registrant elects to perform an extended one-generation stud y, a protocol will need to be subm itted for review and approval by the Agency prior to initiation.
7 If the inhalation indoor (875.1400) and outdoor (875.1300) exposure data are required as anticipated, the DCI would provide that the registrant may elect to submit small chamber studies demonstrating formaldehyde air emission rates and any available Industrial Hygiene air sampling data (explained below). Based on the results of the small chamber studies, the Agency may de termine that the inhalation indoor and outdoor exposure data expected to be required would no longer be necessary. The DCI would provide that, if the registrant elects to perform such small chamber studies , a protocol will need to be submitted for review and approval by the Agency prior to initiation. The Agency also anticipates the need to require that available Industrial Hygiene air sampling data from commercial facilities manufacturing, storing, or using large quantities of bulk or end-products made from preserved materials be submitted, especially for paper mills, facilities manufacturing preserved liquid materials, and other manufacturing facilities where SHMG is used as part of the inhalation indoor (875.1400) and outdoor (875.1300) exposure studies expect ed to be required.Docket Number: EPA-HQ-OPP-2011-0615 www.regulations.gov

14 of 14 875.1600 Application exposure data reporting and calculations TGAI 24

875.2900 Data reporting and calculations TGAI 24

850.5400 Algal Toxicity Tier II using freshwater green alga, Selenastrum capricornutum TGAI 12

835.1110 Activated Sludge Sorption TGAI 12
835.2120 Hydrolysis TGAI 12
835.2240 Photodegradation in water TGAI 12

850.6800 Modified activated sludge, respiration inhibition test 8 TGAI 12

835.3110 Ready Biodegradability 8 TGAI 12

835.3220 Porous Pot Test 8 TGAI 12

835.3240 Simulation Test – Aerobic Sewage Treatment: A. Activated Sludge Units 8 TGAI 12

835.3280 Simulation Tests to Assess the Biodegradability of Chemicals Discharged to Wastewater 8 TGAI 12

8 The results of the Activated Sludge Respiration Inhibitio n Test (ASRI) expected to be required will determine which of these three biodegradation tests would be anticipated to be required. If the ASRI test EC 50 is less than or equal to 20 mg/L, then either the Biodegradation in Activated Sludge Study or Simulation Test – Aerobic Sewage Treatment: A. Activated Sludge Units or the Porous Pot Test would be anticipated to be required. If the ASRI test EC 50 is greater than 20 mg/L, then the applicant would choose to conduct either: (i) Ready Biodegradability or (ii) a) Biodegradation in Activated Sludge or b) Simulation Test – Aerobic Sewage Treatment: A. Activated Sludge Units or c) the Porous Pot Test. If the Ready Biodegradability study is conducted and passes, then no further testing would be expected to be required. If, however, the an timicrobial fails the Ready Biodegradability study, then the Biodegradation in Activated Sludge or Simulation Test – Aerobic Sewage Treatment: A. Activated Sludge Units, or the Porous Pot study would be expected to be required.