### Page 2 of 14 this assessment the Agency requires fate da ta such as hydrolysis, aqueous photolysis, modified activated sludge respiration inhibit ion, ready biodegradability, porous pot test, or simulation test. SHMG is practically non- toxic to avian species on an acute oral and subacute dietary basis; practically non-toxic to mammals on an acute oral basis; and practically non-toxic to freshwater f ish and invertebrate. For the ecological risk assessment, including an endangered species asses sment for all uses, the Agency requires the algal toxicity data.

Introduction

Glycine, N-(hydroxymethyl)-monosodium salt (an N-methylol) is an alkaline preservative, also known as S odium h ydroxy m ethyl g lycinate (SHMG). It is a clear alkaline liquid with a mild characteristic odor. It is in a class of chemicals known as formaldehyde-releasing preservatives used in many commercially available products, including shampoos, conditioners, soaps, shower gels, moisturizers, body sprays, makeup remover, around-eye cream, moistur izer, anti-aging, styling gel/lotion, hair relaxer, baby wipes, room sprays, cleaning agents, and pesticides to help preserve them from bacterial or fungal growth. The first product conta ining SHMG as an active ingredient was registered in the United States on June 18, 1997 for use as an industrial use only preservative/microbiocide for use in aque ous compositions, such as liquid soaps, fabric cleaning & care products, water-based clea ning products, waterborne coatings, waterbased adhesives, printing supplies, polishes and tex tile emulsions. Currently there is only one end use product registered with SHMG as an active ingredient for the material preservative use listed in Table 1. A Rereg istration Eligibility Decision (RED) has not been issued by EPA for SHMG because the initial registration date was after the November 1984, the mandated cutoff for init iation of the RED process. A RED was issued by EPA for Formaldehyde in June 2008 1



### .

Table 1. Registered Product of Sodium hydroxymethylglycinate

Registration # Registration Name Company
Name Formulation Type % of
Active Ingredient

57978-4 Suttocide A 50% Solution ISP Chemicals,
LLC Ready-to-Use
Solution 

### 50

EPA Reg. No. 57978-4 Suttocide A 50% Solution A Broad Spectrum Preservative and Bocide. Active Ingredient: Sodium Hydroxymethylglycinate 50.0%

Suttocide A 50% Solution is an industrial microbiocide for use in aqueous compositions, such as liquid soaps, fabric cleanin g & care products, water-based cleaning

1 http://www.epa.gov/pesticides/reregistration/REDs/formaldehyde-red.pdf

### Page 3 of 14 products, waterborne coatings, water-ba sed adhesives, printing supplies, polishes and
textile emulsions.

Suttocide A 50% Solution is a biocidal age nt used to inhibit the growth of bacteria and fungi. It is for indoor commercial and industrial use and is generally effective at concentrations of 0.1% to 0.5% (2 to 10 gallons of Suttocide A 50% Solution per 1,000 gallons of the product being treated. This will provide 1,000 to 5,000 ppm of active ingredient).

The Agency has conducted a review of the available product chemistry, environmental fate, and ecotoxicity data for SHMG. The findings are summarized below.

A. Product Chemistry Summary (50% TGAI Solution)

Common Name: Glycine, N-(hydroxymethyl)-monosodium salt
Chemical Names: Sodium hydroxymethylamino acetate
S odium h ydroxy m ethyl g lycinate (SHMG)
Trade and Other Names: Suttocide A; Integra 44
OPP Chemical Code: 128972 CAS Registry Number: 70161-44-3
Case: 5030 Chemical Family: Carboxylic acid salt
Molecular Formula: C 3 

### H 6 

### NNaO 3 

### Molecular weight: 127.07
Molecular Structure:

Color: Pale to clear yellow liquid.

Physical State: Liquid.

Odor: Mild characteristic odor of aromatic compound.

Stability: Stable under normal conditions of handling, use and transportation.

Oxidation/Reduction: Does not contain oxidizing or reducing agents.

Flammability-Flash Point: Not flammable; Flash Point: 100°C (212°F).

Explodability: Not applicable. Product is not potentially explosive.

Storage Stability: Stable under conditions of use and expected storage.

Miscibility: Not applicable. Product is not an emulsifiable liquid
intended to be diluted with petroleum distillates.

### Page 4 of 14 Corrosion Characteristics: Minimally corrosive to steel.

Dielectric breakdown voltage: 

### Not applicable. Product is not intended to be used around electrical equipment.

pH: 11-12 (1% solution).

UV/Visible absorption: Not provided.

Viscosity: 21 cps @ 23°C

Melting point: Not applicable. Product is liquid.

Boiling Point: 210°F

Density: 1.28

– 1.3 Specific Gravity: 1.28 @ 25oC

Dissociation Constant: pK b 

### - 8.41

Log K o/w 

### or log P : Not required. Chemical is polor.

Solubility: Soluble in water.

Vapor Pressure: 1.0 mmHg @ 20°C (water)

Enf. Analytical Method: Decomposition and Ion Chromatography.

Product Chemistry Summary (97% TGAI Powder created in the laboratory)

Color: White to off-white free flowing powder.

Physical State: Powder.

Odor: None to a mild odor char acteristic of aromatic compounds.

Stability: Stable under normal condition s of use and storage.

Oxidation/Reduction: Does not contain oxidizing or reducing agents.

Flammability-Flash Point: Not applicable. Technical chemical is a powder and does not contain combustible liquids.

Explodability: Technical chemical is not potentially explosive.

### Page 5 of 14 Storage Stability: Stable under conditions of use and expected storage.

Miscibility: Not required. Technical chemical is not an emulsifiable liquid.

Corrosion Characteristics: Not applicable. Technical chemical is a dry powder
and is non-corrosive.

Dielectric breakdown voltage: 

### Not applicable. Product is not intended to be used around electrical equipment.

pH: 10.41 ± 0.08

UV/Visible absorption: Not provided.

Viscosity: Not required. Technical chemical is a powder.

Melting point: On-set of decomposition at 80°C. Melting point at
151°C.

Boiling Point: Not required. Technical chemical is not a liquid.

Density: Bulk Density: 0.58 g/ml.

Dissociation Constant: pK b 

### - 8.41 carboxylic acid salt (-COO NA+); pK b 

### ≥ - 11.0 secondary amine (-NH-)

Log K o/w 

### or log P : Not required. Technical chemical is polor (97%). -6.19 (EPI Suite).

Solubility: PAI in water ~1344 .4 ± 3 .9 g/L

Vapor Pressure: Not applicable. Powder is highly hygroscopic.
2.43 ×10 -11 

### mm Hg (Source: EPI Suite).

Henry's Law Constant: 1.81E-012 atm-m3/mole 25 o C (Source: EPI Suite).

Enforcement Analytical
Method: Decomposition and Ion Chromatography

.



### All product chemistry data requirements have been satisfied for the active ingredient SHMG. (Source: MRIDs 41980401, 41980402, 41980403, & 41980003).

B. Environmental Fate Summary

### Page 6 of 14 SHMG is an aminoacid (glycine) derivative produced by the condensation reaction of the sodium salt of glycine with formaldehyde, in aqueous medium in a molar ratio of 1:1. SHMG is highly soluble in water. Maximum authorized concentration in pesticide and cosmetic products is 0.5%. In an aqueous solution, sodium hydroxymethyl glycinate is decomposed to release formalde hyde. One molecule of formaldehyde is formed by the decomposition of each molecule of sodium hydroxymethyl glycinate, as
described below. The total fr ee formaldehyde content in a product containing 0.5% sodium hydroxymethyl glycinate corresponds to 0.118%. The decomposition product of sodium hydroxymethyl glycinate, e.g. sodium glycinate cannot be considered harmful.

SHMG 6 R G L X P

 J O \ F L Q D W H ) R U P D O G H K \ G H



### Formaldehyde releaser SHMG (Suttocide A 50%) is an aqueous solution that decomposes to sodium glycinate and then formaldehyde. No risk assessment was performed for SHMG at the time of the reg istration. The Agency has not received any guideline environmental fate studies on SHMG and fate studies are required to conduct
an environmental fate assessment for material preservatives (including SHMG) that may potentially pass through waste water treatment plants (WWTPs) and may be discharged into terrestrial and aquatic e nvironments. For this assessment the Agency anticipates needing those data outlined on page 10 of this document.

Water Quality

SHMG is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act, based on information provided at the Agency’s National Pesticides Cause of Impa irment of Waters websit e (searched April 7, 2011) 2 

### . In addition, no Total Maximum Dail y Loads (TMDL) have been developed
for SHMG , based on information provided at the Agency’s National Pesticide TMDL web site (searched April 7, 2011) 3 

### . More information on impaired water bodies and
TMDLs can be found at http://www.epa.gov/owow/tmdl/ . The Agency invites submission of water quality data for this pesticide. To the extent possible, data should conform to the quality standards in Appendix A of the OPP Standard Operating Procedure: Inclusion of Impaired Water Body and Other Water Quality Data in OPP’s Registration Review Risk Assessment and Management Process (see: http://www.epa.gov/oppfea d1/cb/ppdc/2006/november06/session1-sop.pdf ), in order to ensure they can be used quantitatively or qualitatively in pesticide risk assessments.

2

. http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885

3 http://iaspub.epa.gov/tmdl_waters10/attains_nation. tmdl_pollutant_detail?p_pollutant_group_id=885&p_p ollutant_group_name=PESTICIDES

### Page 7 of 14 C. Ecological Effects Summary

No ecological risk assessment was performed for SHMG at the time of the registration. SHMG is a formaldehyde-relea ser. Available ecotoxicity guideline studies for SHMG and the formaldehyde degradate and the results are summarized in Tables 2 and 3. The Agency's conclusi ons for the terrestrial a nd aquatic effects studies are as
follows.

a. Toxicity to Terrestrial Animals

Birds, Acute and Subacute

SHMG is practically nontoxic to a vian species on an acute oral and subacute dietary basis.

Formaldehyde degradate: 37% ai formaldehyde is slightly toxic to avian species on an acute oral basis and practically non-toxic on a 

### subacute dietary
basis

.



### Toxicity to Mammals

SHMG is practically nontoxic to mammals on an acute oral basis.

Formaldehyde degradate: Technical grade formaldehyde (37% a.i.) 

### is moderately toxic to mammals on an acute oral basis.

There is currently no 2-generation rat reproduction study for SHMG but in the human health scoping document it has been identified as a data gap.

b. Toxicity to Aquatic Animals

Freshwater Fish and Invertebrates

SHMG is practically nontoxic to warm/c old freshwater fish and aquatic
invertebrates.

Formaldehyde degradate: 37% ai formaldehyde is slightly to 

### practically nontoxic to freshwater fish and slightly toxic to freshwater invertebrates.

c. Toxicity to Aquatic Plants

Freshwater Algae

No algal toxicity data have been submitted. For the ecological risk assessment, including an endangered spe cies assessment for all uses, the Agency anticipates needing the algal tox icity data outlined on page 10 of
this document.

### Page 8 of 14 Table 2. Ecotoxicity Data Summary for Sodium hydroxymethyl glycinate

MRID

No. COMMON
NAME TAXONOMIC
NAME GUIDE
LINE TEST
TYPE %
AI STUDY
TIME DOSE
TYPE TOXI
CITY TOX
LEVEL NOEL STUDY
STATUS TOX
CATEGORY Avian Acute Oral Toxicity

41980404 Bobwhite quail Colinus virginianus 850.2100 (71-1) O 97 14 days LD 50 >2250 mgk 486 Acceptable Practically nontoxic Avian Subacute Dietary Toxicity

41980405 Mallard
duck Anas platyrhynchos 850.2200 (71-2b) D 97 8 days LC 50 >5620 ppm 5620 Acceptable Practically
nontoxic

41980406 Bobwhite quail Colinus virginianus 850.2200 (71-2a) D 97 8 days LC 50 >5620 ppm 5620 Acceptable Practically
nontoxic
Freshwater Fish Acute Toxicity

44105802 Rainbow

trout Oncorhynchus mykiss 850.1075 (72-1) F 49.53 96 hr LC 50 106 ppm 35 Acceptable Practically
nontoxic

44105803 Bluegill
sunfish Lepomis macrochirus 850.1075 (72-1) F 49.53 96 hr LC 50 75 ppm 40 Acceptable Slightly
nontoxic Freshwater Invertebrate Acute Toxicity

44105801 Water flea Daphnia

magna 850.1010 (72-2) F 49.53 48 hr EC 50 39 ppm 15 Acceptable Slightly toxic

Mammalian Acute Oral Toxicity

42484501 Rat
------ 81-1 ----- 50% soln. ----- LD 50 LD 50 LD 50 2300(M) 2100(F)

2100 (combined) mg/kgbw ----- Acceptable Practically

non

- toxic (III)

Mammalian Subchronic Oral Toxicity

41980429 SpragueDawleyRats ----- 82-1 ----- 50% soln 28 days LOEL 640 mg/kgbw/day 160 Acceptable

42005801 SpragueDawley Rat ----- 82-1 ----- 50% Soln. 90 days LOEL Not determined mg/kgbw/day 160 Acceptable No compound
related effects

were observed
Test Type

— O: oral; D: dietary; F: flow-through
Tox Level

— mgk: milligrams per kilogram-body weight; ppm: parts per million (equivalent to milligrams per kilogram-diet (mg/kg- diet) for dietary exposure and milligrams per liter (mg/ L) for aquatic exposures) Categories of acute toxicity for aquatic organisms (U.S. EPA, 2004) based on EC 50 /LC 50 (mg/L): < 0. 1 very highly toxic; 0.1-1 highly toxic; > 1-10 moderately toxic; >10-100 slightly toxic; >100 practically nontoxic. Categories of acute toxicity to terrestrial animals, avian and mammalian (U.S. EPA, 2004). LC 50 (ppm): < 50 very highly toxic; 50 - 500 highly toxic; 501

– 1000 moderately toxic; 1001-5000 slightly toxic; >5000 practically non-toxic. LD50 (mg/kg bw): < 10 very highly toxic; 10 - 50 highly toxic; 51 - 500 moderately toxic; 501-2000 slightly toxic; >2000 practically non-toxic.



### Table 3. Ecotoxicity Data Summa ry for Formaldehyde 37%

MRID

No. COMMON
NAME TAXONOMIC
NAME GUIDE
LINE TEST
TYPE %
AI STUDY
TIME DOSE
TYPE TOXI
CITY TOX
LEVEL NOEL STUDY
STATUS TOX
CATEGORY Avian Acute Oral Toxicity

148774 Bobwhite quail Colinus virginianus 850.2100 (71-1) O 37 21 days LD 50 790 mgk 464 Acceptable Slightly
toxic Avian Subacute Dietary Toxicity

148775 Mallard duck Anas platyrhynchos 850.2200 (71-2b) D 37 8 days LC 50 >5000 ppm 5000 Acceptable Practically nontoxic

148773 Bobwhite quail Colinus virginianus 850.2200 (71-2a) D 37 8 days LC 50 >5000 ppm 5000 Acceptable Practically
nontoxic
Freshwater Fish Acute Toxicity

132485 Rainbow

trout Oncorhynchus mykiss 850.1075 (72-1) S 37 96 hr LC 50 118 ppm 17 Acceptable Practically
nontoxic

132485 Bluegill sunfish Lepomis macrochirus 850.1075 (72-1) S 37 96 hr LC 50 100 ppm 50 Acceptable Slightly nontoxic

### Page 9 of 14 MRID

No. COMMON
NAME TAXONOMIC
NAME GUIDE
LINE TEST
TYPE %
AI STUDY
TIME DOSE
TYPE TOXI
CITY TOX
LEVEL NOEL STUDY
STATUS TOX
CATEGORY Freshwater Invertebrate Acute Toxicity

148772 Water flea Daphnia

magna 850.1010 (72-2) S 37 48 hr EC 50 14.31 ppm ----- Acceptable Slightly toxic

Mammalian Acute Oral Toxicity

 *XLQHD

3LJ ------ 81-1 ----- 37.3% soln. ----- LD 50 260 mg/kgbw ----- Acceptable moderately
toxic

II
Test Type

— O: oral; D: dietary; S: Static
Tox Level

— mgk: milligrams per kilogram-body weight; ppm: parts per million (equivalent to milligrams per kilogram-diet (mg/kg- diet) for dietary exposure and milligrams per liter (mg/L) for aquatic exposures) Categories of acute toxicity for aquatic organisms (U.S. EPA, 2004) based on EC 50 /LC 50 (mg/L): < 0. 1 very highly toxic; 0.1- 1 highly toxic; >1 -10 moderately toxic; >10-100 slightly toxic; >100 practically nontoxic. Categories of acute toxicity to terrestrial animals, avian and mammalian (U.S. EPA, 2004). LC 50 (ppm): < 50 very highly toxic; 50 - 500 highly toxic; 501

– 1000 moderately toxic; 1001-5000 slightly toxic; >5000 practically non- toxic. LD50 (mg/kg bw): < 10 very highly toxic; 10 - 50 highly toxic; 51 - 500 moderately toxic; 501-2000 slightly toxic; >2000 practically non-toxic.



### Adverse Ecological Incidents

There are no reported incidents in the Agency's Ecological Incident Information System (EIIS) regarding SHMG. The absence of documented incidents does not necessarily mean that such incidents did not occur.

Ecological Effects Risk Assessment

An ecological risk assessment was not conducted on the SHMG ‘s material preservative use patterns described in t his document. SHMG uses that have potential for environmental exposure are material preservatives di scharges. The Agency needs to conduct environmental fate and ecological risk ass essments for material preservatives that potentially pass through waste water treatm ent plants (WWTPs) and may be discharged into terrestrial and aquatic e nvironments. For this ecological risk assessment, including an endangered species assessment for all uses, the Agency anticipates needing the algal toxicity data outlined on page 10 of this document.

The Agency has not conducted a risk assessment for SHMG that supports a complete endangered species effects de termination. The ecological risk assessment planned during registration review will al low the Agency to determine whether SHMG ’s use has “no effect or “may affect” federally listed threatened or endangered species (listed species) or their de signed critical habitats. When an assessment concludes that a pesticide’s use “may affect” a listed spec ies or its designated critical habitat, the Ag ency will consult with the U.S. Fish and Wildli fe Service and/or Nati onal Marine Fisheries Services (the Servic es), as appropriate.

### Page 10 of 14 Environmental Fate and Ecotoxicity Data Gaps and Anticipated Work

Environmental fate and ecological risk assessm ents have not been conducted for SHMG. The Agency needs to c onduct environmental fate and ecological risk assessments for material preservati ves that potentially pass through waste water treatment plants (WWTPs) and may be discharged into terrestrial and aquatic environments. Therefore, the Agency anticipates nee ding the proposed environmental fate and ecotoxicity data for SHMG and/or any of its ma jor degradation products that are of potential concern for all registered uses of SHMG. The following environmental fate and ecotoxicity data are needed to conduct an environmental fate and ecological risk

assessment:

The Agency anticipates needing the following data to conduct a complete environmental fate assessment for mate rial preservative uses:

o (GLN 835.2120) Hydrolysis;

o (GLN 835.2240) Photodegradation in water;

o (GLN 850.6800) Modified Activated Sl udge Respiration Inhibition; and

o (GLN 835.3110) Ready biodegradability, (GLN 835.3220) Porous Pot Test, or (GLN 835.3280) Simulation Tests to Assess the Biodegradability of Chemicals Discharged to Wastewater 4



### .

The Agency anticipates needing the f ollowing algal toxicity data in order to conduct a complete ecological risk assessment, including an endangered species assessment:

o (GLN 850.5400) algal toxicity (Tier II) using freshwater green alga, Selenastrum capricornutum.

4 The results of the Activated Sludge Respiratio n Inhibition Test (ASRI) determine which of these biodegradation tests are 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 the Po rous Pot Test is required. If the ASRI test EC 50 is greater than 20 mg/L, then the applicant must choose either: (i) Ready Biodegradability or (ii) Biodegradation in Activated Sludge or the Porous Pot Test. If the antimicrobial passes the ready biodegradability study, then no further testing is requ ired. If, however, the antimicrobial fails the ready biodegradability study, then the Biodegradation in Ac tivated Sludge or the Porous Pot study is required.

### Page 11 of 14 

## Appendix A. Environmental Fate Guideline Study Justifications

Guideline Number: 835.2120 Study Title: Hydrolysis Practical Utility of the Data 1) What is the value of the study? Data characterizing the rate of hydrolytic degradation of 

### SHMG and/or the formation and decline of degradates is important in determining the persistence and concentrations of 

### SHMG and potential degradates over time in various aquatic environments. For ou tdoor uses, 

### SHMG can reach surface water through direct contact or discharge to WWTPs. 

### SHMG may also reach surface water or groundwater through run -off or leaching processes. The Agency w ill evaluate the potential risks of concern.

2) How would the data be used? The data would establish the significance of chemical hydrolysis as a route for degradation and identify, if possible, the hydrolytic transformation products formed that may adversely affect non

- target organisms and may contaminate water and food source of aquatic organisms. The data would also help establish the hydrolytic half -life of 

### SHMG and possibly degradates, and assist in developing a degradation pathway.

3) How could the data affect the risk assessment? The results of hydrolysis data wo uld indicate if 

### SHMG is persistent or if it degrades into other products that may adversely affect nontarget organisms and may contaminate their food and water and possibly soil.

4) What is triggering the need for this data? Hydrolysis data is needed to conduct the fate assess ment to support material preservatives uses for SHMG.



### Guideline Number: 835.2240 Study Title: Photodeg radation in water Practical Utility of the Data 1) What is the value of the study? Biocides introduced into aqueous systems in the envi ronment can undergo photolytic transformation by sunlight. Results from the photolysis study wi ll indicate the stability and persistence of 

### SHMG and potential degradates in an aquatic environment when exposed to sunlight. The Agency will evaluate the potential risks of concern.

2) How would the data be used? The data would establish the significance of chemical photolysis as a route for degradation and identify, if possible, the photolytic degradation p roducts formed that may adversely affect non- target organisms and may contaminate water and food source of aquatic or ganisms. The data would also help establish the photolytic half -life of 

### SHMG and possibly degradates, and assist in developing a degradation pathway.

3) How could the data affect the risk assessment? The results of photolysis data would indicate if 

### SHMG is persistent or if it degrades into degradation products that may adversely affect nontarget organism s and may contaminate their food. The results of the photolysis data would expand the understanding of the re sults of the hydrolysis data since environmental aquatic conditions usually involve exposure to sunlight.

4) What is triggering the need for this data? Aqueous photodegradation data is needed to conduct the fa te assessment to support material preservative
uses for 

### SHMG

.

### Page 12 of 14 Guideline Number: 850.6800; OECD 209 Study Title: Modified Activated Sludge, Respiration In hibition Test for Sparingly Soluble Chemicals; Activated Sludge Respiration Inhibition Test Rationale for Requiring the Data An activated sludge, respir ation inhibition test (ASRI) is needed to identify wh ether this pesti cide could harm activated sludge microorganisms found in biological wastewater treatment systems. The Agency will use these data to determine the potential impact of this chemical on waste water treatment plants (WWTPs) as a result of respiration inhibition of activated sludge microorganisms. This test is also necessary to enable EPA to establi sh correct concentrations for use in the biodegradability test, if that test is determined to be adequate for assessing biodegradatio n potential. Furthermore, the results of the Activated Sludge Respiration Inhibition Test (ASRI) determine which biodegradation test is 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 the Porous Pot Test is required. If the ASRI test EC 50 is greater than 20 mg/L, then the applicant must choose either: (i) Ready Biodegradability or (ii) Biodegradation in Activated Sludge or the Porous Pot Test. If the antimicrobial passes the ready biodegradability study, then no further testing is required. If, however, the antimicrobial fails the ready biodegrad ability study, then the Biodegradation in Activated Sludge or the Poro us Pot study is required.

Practical Utility of the Data
1. How will the data be used? The data will be used to assess potential adverse effects to activated sludge microorganisms. In addition,
the data will be used to determine whether or not label restrictions are needed. The study will identify the inhibitory effect of this chemical on the treatment plant’s microorganisms’ respiration at different concentrations of the test substance and will identify the EC 50 , the effective concentration of the test substance at which the respiration rate is 50% of that shown by the control under conditions in this guideline. The data will also determine suitable non -inhibitory concentrations to be used in biodegradability tests.

2. How could the data impact the Agency’s future decision -making? If the data indicate a high degree of activated sludge respiration inhibition, a more rigorous test for biodegradation in wastewater treatment will be required than the ready biodegradability test. Also, if a high degree of respiration inhibition is demonstrated a nd biodegradation and/or sorption is indicated to be negligible, the Agency may require label restrictions or mitigation measures to insure that activated sludge microorganisms will not be adversely impacted.

### Page 13 of 14 Guideline Numbers: 835.3110, 835.3220, or 835.3280 Study Titles: Ready Biodegradability, Porous Po t Test, or Simulation Tests to Assess the Biodegradability of Chemicals Discharged to Wastewater (also referred to as Biodegradati on in Activated Sludge), respectively Rationale for Requiring the Data For antimicrobial chemicals that go down -the-drain and reach a WWTP, as part of its screening-level environmental fate assessment, EPA will analyze the potential impact of the antimicrobial chemical on the microorganisms in the biological treatment process es of a WWTP. Biodegradation is an impor tant environmental pathway in which the antimicrobial is broken down by bacter ia. This study results supply information on the rate of biological breakdown and the completeness of the degradation to carbon dioxide an d water. A ready biodegradability study would allow the Agency to determine whether or not the chemical achieves ‘‘pass levels’’ for ready biodegradability (e.g., 70% removal of dissolved organic carbon). The results of the Activated Sludge Respiration Inhibition Test (ASRI) determine which of these three biodegradatio n tests are required. If the ASRI test EC 50 is less than or equal to 20 mg/L, then either the Biodegradation in Activated Sludge Stud y or the Porous Pot Test is required. If the ASRI test
EC 50 is greater than 20 mg/L, then the applicant must choose either: (i) Ready Biodegradab ility or (ii) Biodegradation in Activated Sludge or the Porous Pot Test. If the an timicrobial passes the ready biodegradability study, then no further testing is requi red. If, however, the antimicrobial fails the ready biodegradability study, then the Biodegradation in Activated Sludge or the Porous Pot study is required. Practical Utility of the Data
1. How will the data be used? The data from a biodegradation study will be used to determine the percent remo val of the antimicrobial as a result of biodegradation of the antimicrobial by activated sludge micr oorganisms. Percent removal via biodegradation is a key input used to determine concentrations of the antimicr obial in surface water immediately downstream of wastewater treatment plants. The concentrations of antimicrobial p esticide immediately downstream of wastewater treatment plants are used to assess exposure and risk to non -target endangered and non-enda ngered species. Exposure data are integral parts of the risk equation for determining the impact of pesticides to beneficial non

- target organisms through direct exposure from their food sources and habitat.

In addition, the data will be used to determine whether or not additional studies an d/or label restrictions are needed. If the chemical does not achieve a ‘‘pass level’’ for ready bi odegradability, then the Agency would determine that the chemical has the potential to p ass through the WWTP and therefore may be discharged in to the aquatic environment potentially resulting in exposure to non

- target species. This determination would trigger further data requirements to assess the chemical’s impact on the aquatic environment upon release.

2. How could the data impact the Agency’s future decision -making? If the chemical is found to be readily biodegraded, then activated sludge microorganisms would be identified as highly biodegradable (90% removal via biodegra dation). This result would be used in conjunction with wastewater treatment plant influent volume and measurement endpoints for aquati c organisms to determine co ncentrations of antimicrobial pesticide downstream of wastewater treatment plants. If hi gh inhibition of activated sludge microorganisms (i.e., EC 50 less than or equal to 20 mg/L) is determined in an ac tivated sludge respiration inhibition test, then higher -tiered wastewater treatment plant (WWTP) biodegradation studies an d/or an activated sludge sorption isotherm study may be triggered. I f results of higher-tier WWTP biodegradation tests indicate low or negligible removal by biodegradation, the risk assessments for this chemical woul d reflect the magnitude of potential risk derived from the chemical’s lack of biodegradability. The risk as sessment may result in the Agency requiring label restrictions that would be necessary for the products to meet the “no unre asonable adverse effects” requirements of FIFRA (e.g., changes to the directions for disposal).

In addition, EPA is required by sec tion 7(a)(2) of the ESA to ensure that any action it authorizes or takes “...is not likely to jeopardize the continued existence of any endanger ed or threatened species or result in the destruction or
adverse modification of critical habitat” and to use the best scientific data available” in carrying out this obligation.
The data EPA intends to call in are ne cessary to inform the determination required by the ESA as to whether continued registration of a pesticide is not likely to jeop ardize the species or its critical habitat. Absent this data EPA may not be able to conclude that this pesticide will not harm enda ngered species and may ther efore need to consider other limitations on the use of the pesticide in order to fulfill the Agency’s statutory obligati ons under the ESA. The lack of these data will limit the flexibility that the Agency and registrants have in coming into compliance with the ESA and could result in use restrictions which are unnecessarily severe.

### Page 14 of 14 

## Appendix B: Ecological G uideline Study Justifications

Guideline Number: 850.5400 Study Title: Algal toxicity (Tier II) using freshwater green alga, Selenastrum capricornutum Practical Utility of the Data 1) What is the value of the study? As part of an initial risk assessment, one indicator plant species is tested for phytotoxicity. This study would allow the Agency to categorize 

### SHMG as toxic or non- toxic to plants. If toxic, additional higher tier plant tests would be needed. An endangered species assessment for endangered or threatened plants is not possible without this study.

2) How would the data be used? This study would be used to evaluate the toxicity of 

### SHMG to non- target plants in terrestrial and aquatic ecosystems.

3) How co uld the data affect the risk assessment? Adverse effects to non

- target plants in terrestrial and aquatic ecosystems may result in mitigation to protect species at risk. Mitigation might include reduced la bel dosages, neutralization of effluents prior to discharge into water, restrictions on use in sensitive ecosystems or where endangered species are present, or other mitigation measures.

4) What is triggering the need for this data? Increased concern from state regulators and the public to evaluate impact s on WWTP operations, endangered species, and persistence in the environment, since initial registration, have triggered the need for this study. Green algae are critical to ecosystem health and productivity.



### Sign-off Date : 08/11/11
DP Barcode No. : D392286