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United States Chemical Safety September 2011 

Environmental Protection and Pollution Prevention 

Agency (7510P) 

 

Glycine, N-(Hydroxymethyl)-Monosodium Salt 

(SHMG) 

Summary Document 

Registration Review: Initial Docket 

September 2011 

 
Docket Number: EPA-HQ-OPP-2011-0615 

www.regulations.gov 

Glycine, N-(Hydroxymethyl)-Monosodium Salt 

(SHMG) 

Summary Document 

Registration Review: Initial Docket 

September 2011 

Case # 5030 

Approved By: 

n Harrigan-F elly 

irector, Antimicrobials Division 

Date: 

I I 

20f20 
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TABLE OF CONTENTS 

SHMG Registration Review Team ................................................................................................. 4

I. Preliminary Work Plan -- SHMG ................................................................................................ 5

II. Fact Sheet ................................................................................................................................. 14

III. Summary of Anticipated Data Requirements – SHMG .......................................................... 18

IV. Appendix A: Use Patterns – SHMG .................................................................20 

________________________________________ 

Please Note 

This Preliminary Work Plan and Fact Sheet summarize the Environmental Protection Agency's 

current position based on the following documents: 

1. Summary of Product Chemistry, Environmental Fate, and Ecotoxicity Data for the 

Glycine, N-(hydroxymethyl)-monosodium salt Registration Review Decision Document. 

August 11, 2011 

2. Glycine, N-(hydroxymethyl)-, monosodium salt. Human Health Scoping Document for 

the Registration Review. September 13, 2011 

Additional supporting documents for the Glycine, N-(Hydroxymethyl)-Monosodium Salt Case 

may be found in the registration review docket EPA-HQ-OPP-2011-0615 located on the internet 

at www.regulations.gov. 

 
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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 
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I. Preliminary Work Plan -- SHMG 

Introduction:

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program. All 

pesticides distributed or sold in the United States generally must be registered by the U.S. 

Environmental Protection Agency (USEPA, EPA, or the Agency) based on scientific data 

showing that they will not cause unreasonable risks to human health or the environment when 

used as directed on product labeling. The registration review program is intended to make sure 

that, as the ability to assess risk evolves and as policies and practices change, all registered 

pesticides continue to meet the statutory standard of no unreasonable adverse effects to human 

health or the environment. Changes in science, public policy, and pesticide use practices will 

occur over time. Through the registration review program, the Agency periodically reevaluates 

pesticides to make sure that as change occurs, products in the marketplace can be used safely. 

Information on this program is provided at http://www.epa.gov/oppsrrd1/registration_review/. 

The Agency is implementing the registration review 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 the FIFRA standard for 

registration. The Agency will consider benefits information and data as required by FIFRA. The 

public phase of registration review begins when the initial docket is opened for each case. The 

docket is the Agency’s opportunity to state what it knows about the pesticide and what additional 

risk analyses and data or information it believes are needed to make a registration review 

decision. After reviewing and responding to comments and data received in the docket during 

this initial comment period, the Agency will develop and commit to a final work plan and 

schedule for the Glycine, N-(Hydroxymethyl)-Monosodium Salt Case. 

The first product containing Glycine, N-(hydroxymethyl)-, monosodium salt (PC Code 128972), 

also known as sodium hydroxymethylglycinate or SHMG, as an active 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% Solution, is a biocidal agent registered for use to 

inhibit the growth of bacteria and fungi. It is registered for use as a material preservative in liquid 

soaps, fabric cleaning and care products, water based cleaning products, waterborne coatings and 

polishes, water based adhesives, printing supplies, and textile emulsions. SHMG can also be 

used as a preservative in cosmetics. Cosmetic uses are not regulated by EPA. 

SHMG’s mechanism of antimicrobial action appears to be largely or wholly via release of 

formaldehyde (HCHO). In a 2002 “Opinion,” The EU’s Scientific Committee on Cosmetic and 

Non-food Products Intended for Consumers (SCCNFP) 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 toxicological concern. Formaldehyde is being evaluated as an active 

ingredient separately under registration 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. 
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SHMG is not registered for use in products that may come in direct contact with food. No 

tolerance or tolerance exemption has been established in food as a result of use as a direct or 

indirect food additive, as an active ingredient, or as an inert ingredient. 

EPA did not complete a reregistration eligibility decision (RED) for SHMG because the first 

pesticide product containing SHMG was registered after November 1, 1984. Documents 

associated with the registration review of SHMG can be viewed at www.regulations.gov in 

docket EPA-HQ-OPP-2011-0615. Below is a summary of the issues relevant to this registration 

review case. 

Anticipated Risk Assessment and Data Needs:

The Agency anticipates the need to conduct a comprehensive ecological risk assessment, 

including an endangered species risk assessment, for all uses of SHMG. The Agency 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: 

 No ecological risk assessment has been performed for SHMG. 

 The Agency has not conducted a risk assessment that supports a complete endangered 

species determination for SHMG. The ecological risk assessment 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 species (listed species) or 

their designated critical habitats. When an assessment concludes that a pesticide’s use 

'may affect' a listed species or its designated critical habitat, the Agency will consult with 

the U.S. Fish and Wildlife Service and/or National Marine Fisheries Services (the 

Services), as appropriate. 

 The Agency anticipates the need to require the following additional ecological data for 

use in the registration review of SHMG. 

850.5400 -- Algal Toxicity Tier II using freshwater green alga, 

Selenastrum capricornutum 

 The Agency anticipates the need to require the following additional 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 Test1

 

1

 Based on the results of any required Activated Sludge Respiration Inhibition Test (ASRI), registrants may be able 

to request that EPA waive the requirements for additional biodegradation tests. If the ASRI test EC50 is less than or 

equal to 20 mg/L, registrants would need to perform one of 835.3220, 835.3240, or 835.3280. If the ASRI test EC50

is greater than 20 mg/L, registrants would need to perform either (i) 835.3110 or (ii) one of 835.3220, 835.3240, or 
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835.3110 -- Ready Biodegradability 

835.3220 -- Porous Pot Test 

835.3240 -- Simulation Test – Aerobic Sewage Treatment: A. Activated Sludge Units 

835.3280 -- Simulation Tests to Assess the Biodegradability of Chemicals Discharged 

to Wastewater 

 For more information, please refer to Summary of Product Chemistry, Environmental 

Fate, and Ecotoxicity Data for the Glycine, N-(hydroxymethyl)-monosodium salt 

Registration Review Decision Document, located in the docket. 

Human Health Risk: 

 The Agency did not perform a quantitative human health risk assessment at the time of 

the initial registration based on the low likelihood of exposure and the absence of adverse 

systemic effects in available toxicity studies. 

 Dietary (food) exposure is not expected because the SHMG product cannot be used to 

preserve materials that may come in direct contact with food. 

 Due to the potential for dietary (drinking water) exposure from the material preservative 

use of SHMG, the Agency intends to determine the need for a drinking water assessment 

upon the submission and review of the environmental fate data anticipated to be needed 

for this registration review. 

 To determine the conditions under which residential and occupational exposure to the 

parent compound and/or formaldehyde are likely to occur from the use of SHMG as a 

preservative, the Agency anticipates requiring detailed use and other information, 

presented below, to clarify the conditions, rates, and magnitude of formaldehyde release 

from SHMG under various conditions and in various materials. 

 The Agency anticipates conducting residential risk assessments on adult applicator/user 

dermal and inhalation exposure and postapplication dermal and inhalation exposure to 

adults and children. 

 The Agency anticipates conducting occupational risk assessments on handler dermal and 

inhalation exposure during direct-pour activities, handler dermal and inhalation exposure 

to SHMG and inhalation risk to formaldehyde resulting from use or application of 

preserved water-based materials, and bystander inhalation risk to formaldehyde resulting 

from preservation of water-based materials. 

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

 835.3280. If the antimicrobial reaches pass levels for 835.3110 (i.e., 70% removal of dissolved organic carbon 

(DOC) and 60% removal of theoretical oxygen demand (ThOD) or theoretical carbon dioxide (ThCO2) production 

for respirometric methods) in a 10-day window within the 28-day period of the test, registrants would be able to 

request that EPA waive the requirements for additional biodegradation tests. If the antimicrobial does not pass 

835.3110, the registrants would need to perform one of 835.3220, 835.3240, or 835.3280. 
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 In examining aggregate exposure, EPA takes into account the available and reliable 

information concerning exposures to residues in food and drinking water, and nonoccupational pesticide exposures. If the results 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 residential 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 aggregate assessment for all non-occupational 

sources of formaldehyde. 

 The Agency anticipates the need to require the following additional human health data 

for use in the registration review of SHMG. 

870.3250 -- 90-day dermal toxicity2

870.3465 -- 90-day inhalation toxicity (rat)2

870.3800 -- Reproduction and fertility effects (multigeneration) - rat 

875.1700 -- Product use information 

875.2700 -- Product use information 

875.2800 -- Description of human activity 

875.1100 -- Dermal outdoor exposure 

875.1200 -- Dermal indoor exposure 

875.1300 -- Inhalation outdoor exposure 3

875.1400 -- Inhalation indoor exposure 3

875.1600 -- Application exposure data reporting and calculations 

875.2900 -- Data reporting and calculations 

 The Agency does not anticipate the need to require additional toxicity data on 

formaldehyde through the SHMG 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 review, EPA will reconsider these studies, as 

well as consider any other research involving intentional exposure of human subjects to 

 

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 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 determine 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 expected to be required. 
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SHMG brought to its attention. If EPA determines that the two previously-identified 

intentional exposure human studies (or any additional intentional exposure human studies 

brought to EPA’s attention) are sufficiently sound from a scientific perspective to warrant 

inclusion in future risk assessments, EPA will 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 are met, including but not limited to the 

requirements for EPA ethics review and Human Studies Review Board review of certain 

research involving intentional exposure of human subjects. 

 For more information, please refer to Glycine, N-(hydroxymethyl)-, monosodium salt. 

Human Health Scoping Document for the Registration Review, located in the docket. 

Product Chemistry: 

 The Agency does not anticipate the need to require additional product chemistry data for 

this registration review case at this time. 

 For more information, please refer to Summary of Product Chemistry, Environmental 

Fate, and Ecotoxicity Data for the Glycine, N-(hydroxymethyl)-monosodium salt 

Registration Review Decision Document, located in the docket. 

Endocrine Disruptor Screening Program

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse 

outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and 

chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, 

reproductive, and general or systemic toxicity. These studies include endpoints which may be 

susceptible to endocrine influence, including effects on endocrine target organ histopathology, 

organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, 

and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and 

chronic studies that assess growth, developmental and reproductive 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 screening part of the Endocrine Disruptor Screening Program (EDSP). 

EPA has developed the EDSP to determine whether 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 other such endocrine effects as the Administrator 

may designate.” The EDSP employs a two-tiered approach to making the 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 estrogen, androgen, or thyroid (E, A, or T) hormonal 

systems. Chemicals that go through Tier 1 screening and are found to have the potential to 

interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA 

will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 

testing is designed to identify any adverse endocrine-related effects caused by the substance, and 

establish a dose-response relationship between the dose and the E, A, or T effect. 
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Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between October 

2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 chemicals, 

which contains 58 pesticide active ingredients and 9 inert ingredients. SHMG is not among the 

group of 58 pesticide active ingredients on the initial 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 assays 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 screening battery, please visit our website: http://www.epa.gov/endo/. 

Timeline

EPA has created the following estimated timeline for the completion of the SHMG registration 

review: 

Anticipated Schedule

Activities Estimated Month/Year

Phase 1: Opening the docket 

Open Public Comment Period for Docket September 2011

Close Public Comment Period for Docket November 2011 

Phase 2: Case Development 

Develop Final Work Plan (FWP) March 2012 

Issue DCI March 2013 

Data Submission March 2015 

Open Public Comment Period for Preliminary Risk Assessments September 2016 

Close Public Comment Period for Preliminary Risk Assessments October 2016 

Phase 3: Registration Review Decision 

Open Public Comment Period for Proposed Reg. Review Decision March 2017 

Close Public Comment Period for Proposed Reg. Review Decision May 2017 

Final Decision and Begin Post-Decision Follow-up 2017 

Total (years) 6 

Guidance for Commenters:

The public is invited to comment on EPA’s Preliminary Work Plan and rationale. The Agency 

will carefully consider all comments as well as any additional information or data provided in a 

timely manner prior to issuing a final work plan for the SHMG registration review case. 

Trade Irritants:

Through the registration review process, the Agency intends to solicit information on trade 

irritants and, to the extent feasible, take steps toward facilitating irritant resolution. Growers and 

other stakeholders are asked to comment on any trade irritant issues resulting from lack of 
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Maximum Residue Limits (MRLs) or disparities between U.S. tolerances and MRLs in key 

export markets, providing as much specificity as possible regarding the nature of the concern. 

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 

http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=88

5. In addition, no Total Maximum Daily Loads (TMDL) have been developed for SHMG, based 

on information provided at 

http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id

=885&p_pollutant_group_name=PESTICIDES. 

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/oppsrrd1/registration_review/water_quality_sop.htm), in order to ensure the 

data can be used quantitatively or qualitatively in pesticide risk assessments. 

Environmental Justice:

EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all 

people, regardless of race, color, national origin, or income, in the development, implementation, 

and enforcement of environmental laws, regulations, and policies. To help address potential 

environmental justice issues, the Agency seeks information on any groups or segments of the 

population who, as a result of their location, cultural practices, or other factors, may have 

atypical, unusually high exposure to SHMG compared to the general population. Please 

comment if you are aware of any sub-populations that may have atypical, unusually high 

exposure compared to the general population. 

Structure Activity Relationships: 

EPA must rely upon information of appropriate quality and reliability for each decision made by 

the Agency. In the Office of Pesticide Programs (OPP), the evaluation process for a pesticide 

chemical traditionally begins with the applicant’s submission of a set of studies conducted with 

the specific pesticide chemical of interest. The use of the results of such testing (measured data) 

is a logical, scientifically rigorous process that identifies the physical, chemical, and 

environmental fate properties of the pesticide, as well as the dose and endpoints at which an 

adverse effect can occur in various animal species. 

Today, there is significant interest in alternative techniques, i.e., techniques other than data 

generation that could significantly inform the Agency’s decision-making process. Recently, OPP 

has made increasing use of structure activity relationship (SAR) as part of its regulatory 

decision-making process. In the SAR process, a chemical's molecular structure is compared to 

that of other chemicals for which data are available. These structural similarities are then used to 

make predictive judgments about a chemical’s physical, chemical, and biological properties. 
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Thus, the chemical’s physical, chemical, and biological properties are a function of (or directly 

related to) the chemical’s molecular structure. Quantitative SAR is referred to as QSAR. To 

develop a QSAR, a selected set of measured data on a single physical, chemical, or biological 

property is used to derive a model (an equation) to predict the value of that property. 

Since SAR assessments and QSAR modeling are another set of tools that are available to Agency 

scientists, OPP has begun a process shift that envisions shifting from the current study-by-study 

approach to an approach in which the use of predicted data, generated using validated models, is 

considered along with information from open literature and studies specifically generated under 

Part 161 requirements. All relevant information would be considered as part of a weight-of-theevidence evaluation. 

At this time, EPA believes that for certain endpoints, especially physical/chemical and fate 

properties, that SAR and QSAR might be effectively utilized to fulfill these data requirements 

for many antimicrobial pesticide chemicals. When considering biological properties, at this time, 

EPA believes that SAR and QSAR can be most effectively utilized in the evaluation of 

chemicals that exhibit lower toxicity for human health and/or ecotoxicity parameters. This is 

appropriate because the risk assessment for lower toxicity chemicals can be stream-lined, i.e., a 

screening-level assessment procedure rather than multiple tiers of assessments with progressively 

more data requirements. 

If stakeholders believe that submission of predicted data can fulfill one of the data needs for the 

SHMG Case, then the Agency invites submission of this information. The submitter would be 

expected to supply a rationale describing the utility of the information and provide 

documentation on the scientific validity of the information. The determination that the predicted 

data fulfills the data requirement would be at the sole discretion of the Agency. Pre-submission 

consultation with the Agency is encouraged. 

Additional Information:

Stakeholders are also specifically asked to provide available information and data that will assist 

the Agency in refining its risk assessments, including any species-specific ecological effects 

determinations. The Agency is interested in receiving the following information: 

1. Confirmation on the following label information:

a. Sites of application 

b. Formulations 

c. Application methods and equipment 

d. Maximum application rates 

e. Frequency of application, application intervals and maximum number of 

applications 

f. Geographic limitations on use 

2. Use or potential use distribution 

3. Use history 

4. Usage/use information for non-agricultural uses (e.g., materials preservation) 

5. Typical application interval 

6. State or local use restrictions 
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7. Ecological incidents (non-target plant damage and avian, fish, reptilian, amphibian 

and mammalian mortalities) not already reported to the Agency 

8. Monitoring data 

Next Steps:

After the 60-day comment period closes in November 2011, the Agency will review and respond 

to any comments received in a timely manner, and then issue a Final Work Plan for the SHMG 

case. 
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II. Fact Sheet 

Background Information:

 Active Ingredient: Glycine, N-(hydroxymethyl)-, monosodium salt 

 Other Names: SHMG, sodium hydroxymethylglycinate, Sodium hydroxymethylamino 

acetate 

 Case number: 5030 

 PC Code: 128972 

 CAS number: 70161-44-3 

 Technical registrants: no registered manufacturing-use products 

 First approved for use in a registered product: 1997 

 There are no tolerances or exemptions from tolerances for SHMG. 

 Antimicrobials Division Chemical Review Manager (CRM): Rebecca von dem Hagen, 

vondem-hagen.rebecca@epa.gov

 Antimicrobials Division Product Manager (PM): Marshall Swindell, 

swindell.marshall@epa.gov

 Chemical Structure: 

Use & Usage Information:

 Suttocide A 50% Solution, the only registered SHMG product (EPA Reg. No. 57978-4), 

is a biocidal agent registered for use to inhibit the growth of bacteria and fungi. It is 

registered for use as a material preservative in liquid soaps, fabric cleaning and care 

products, water based cleaning products, waterborne coatings and polishes, water based 

adhesives, printing supplies and textile emulsions. 

 SHMG can also be used as a preservative in cosmetics. Cosmetic uses are not regulated 

by EPA. 

Recent/Pending Regulatory Actions:

 There are no recent or pending regulatory actions for SHMG.

Ecological Risk Assessment Status:

Please refer to Summary of Product Chemistry, Environmental Fate, and Ecotoxicity Data for 

the Glycine, N-(hydroxymethyl)-monosodium salt Registration Review Decision Document., 

located in the docket, for a detailed discussion of the ecological risk assessments. 

 No ecological risk assessment has been conducted on SHMG. 
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 SHMG is practically nontoxic to avian species on an acute oral and subacute dietary 

basis, practically nontoxic to mammals on an acute oral basis, and practically nontoxic to 

warm/cold freshwater fish and aquatic invertebrates. 

 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, technical grade 

formaldehyde (37% a.i.) is moderately toxic to mammals on an acute oral basis and 37% 

ai formaldehyde is slightly to practically nontoxic to freshwater fish and slightly toxic to 

freshwater invertebrates. 

 The Agency has not conducted a risk assessment for SHMG that supports a complete 

endangered species effects determination for SHMG. The ecological risk assessment 

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 species 

(listed species) or their designated critical habitats. When an assessment concludes that a 

pesticide’s use “may affect” a listed species or its designated critical habitat, the Agency 

will consult with the U.S. Fish and Wildlife Service and/or National Marine Fisheries 

Services (the Services), as appropriate. 

Human Health Risk Assessment Status:

Please refer to Glycine, N-(hydroxymethyl)-, monosodium salt. Human Health Scoping 

Document for the Registration Review, located in the docket, for a detailed discussion of the 

human health risk assessment. 

 The Agency did not perform a quantitative human health risk assessment at the time of 

the initial registration based on the low likelihood of exposure and the absence of adverse 

systemic effects in available toxicity studies. 

 In a 2002 “Opinion,” The EU’s Scientific Committee on Cosmetic and Non-food 

Products Intended for Consumers (SCCNFP) 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 toxicological concern. 

Hazard Characterization: 

 SHMG exhibits slight acute oral and dermal toxicity (Toxicity Category III), no dermal 

irritation (Toxicity Category IV), low acute inhalation toxicity (Toxicity Category IV) 

and moderate eye irritation (Toxicity Category II) in animal testing. SHMG is also a 

severe gastrointestinal irritant. 

 Two human dermal sensitization studies that involved intentional exposure to SHMG 

were submitted in 1993 (both studies are combined in a single data volume, MRID 

43514301). SHMG did not cause dermal sensitization in humans at either 0.5 or 1% ai in 

water in the repeat-dose patch tests. In the course of registration review, EPA will 

reconsider these studies, as well as consider any other research involving intentional 
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exposure of human subjects to SHMG brought to its attention. If EPA determines that the 

two previously-identified intentional exposure human studies (or any additional 

intentional exposure human studies brought to EPA’s attention) are sufficiently sound 

from a scientific perspective to warrant inclusion in future risk assessments, EPA will 

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 are met, 

including but not limited to the requirements for EPA ethics review and Human Studies 

Review Board review of certain research involving intentional exposure of human 

subjects. 

Dietary (Food and Water): 

 SHMG product labeling prohibits use in products that may come in direct contact with 

food. 

 The Agency did not complete a dietary risk assessment for the initial registration of the 

only SHMG product. 

Residential: 

 The Agency has not conducted a residential risk assessment for SHMG. 

Aggregate: 

 An aggregate risk assessment has not been conducted for SHMG. 

 In examining aggregate exposure, EPA takes into account the available and reliable 

information concerning exposures to residues in food and drinking water, and nonoccupational pesticide exposures. If the results 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 residential 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 aggregate assessment for all non-occupational 

sources of formaldehyde. 

Occupational: 

 The Agency has not conducted a quantitative occupational risk assessment for SHMG. 

Cumulative: 

 Unlike other pesticides for which EPA has followed a cumulative risk approach based on 

a common mechanism of toxicity, EPA has not made a common mechanism of toxicity 

finding as to SHMG and any other substances and SHMG does not appear to produce a 

toxic metabolite produced by other substances. For the purposes of this registration 

review, therefore, EPA has not assumed that SHMG has a common mechanism of 
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toxicity with other substances. For the purposes of this action, therefore, EPA has not 

assumed that SHMG has a common mechanism of toxicity with other substances. For 

information regarding EPA’s efforts to determine which chemicals have a common 

mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the 

policy statements released by EPA’s Office of Pesticide Programs concerning common 

mechanism determinations and procedures for cumulating effects from substances found 

to have a common mechanism on EPA’s website at 

http://www.epa.gov/pesticides/cumulative/.

Incidents:

Ecological: 

 No SHMG ecological incidents have been reported in the Agency’s Ecological Incident 

Information System (EIIS). 

Human Health: 

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

Tolerances and International Harmonization: 

 There are no tolerances or exemptions from tolerances for SHMG. 

Data Call-In Status:

 A Data Call-In has never been issued for SHMG. 

Labels: 

Registered products, including EPA registration numbers are provided in Table 1 below. For 

future reference, during registration review a list of product registration numbers will be included 

in the docket. Product registration labels may be obtained from the Pesticide Product Label 

System (PPLS) website at: http://oaspub.epa.gov/pestlabl/ppls.home. 

Table 1. Registered Products – SHMG 

Registration # Registration Name Company Name Formulation Type % A.I. 

57978-4 

Suttocide A 50% 

Solution ISP Chemicals, LLC Ready-to-Use 

Solution 

50

 
Docket Number: EPA-HQ-OPP-2011-0615 

www.regulations.gov

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III. Summary of Anticipated Data Requirements – SHMG 

The table below summarizes anticipated data needs for the SHMG Case in Section I of this 

document (Preliminary Work Plan), Summary of Product Chemistry, Environmental 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.

Table 2. Summary of Anticipated Data Requirements – SHMG 

Guideline 

Number Anticipated Data Requirement Test Material 

Estimated Timeframe 

(Measured in months from 

DCI Receipt) 

870.3250 90-day dermal toxicity4 TGAI 24 

870.3800 90-day inhalation toxicity (rat)4 TGAI 24 

870.3800 Reproduction and fertility effects 

(multigeneration) - rat 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 exposure5 TGAI 24 

875.1400 Inhalation indoor exposure5 TGAI 24 

875.1600 

Application exposure data reporting and 

calculations TGAI 24 

875.2900 Data reporting and calculations TGAI 24 

 

4

 If the environmental fate studies that are expected to be 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. 

5

 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 determine 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 expected to be required. 
Docket Number: EPA-HQ-OPP-2011-0615 

www.regulations.gov

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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 

835.3110 Ready Biodegradability TGAI 12 

835.3220 Porous Pot Test TGAI 12 

835.3240 

Simulation Test – Aerobic Sewage 

Treatment: A. Activated Sludge Units TGAI 12 

835.3280 

Simulation Tests to Assess the 

Biodegradability of Chemicals Discharged to 

Wastewater 

TGAI 

12 

850.6800 

Modified activated sludge, respiration 

inhibition test 6 TGAI 12 

 

6

Based on the results of any required Activated Sludge Respiration Inhibition Test (ASRI), registrants may be able 

to request that EPA waive the requirements for additional biodegradation tests. If the ASRI test EC50 is less than or 

equal to 20 mg/L, registrants would need to perform one of 835.3220, 835.3240, or 835.3280. If the ASRI test EC50

is greater than 20 mg/L, registrants would need to perform either (i) 835.3110 or (ii) one of 835.3220, 835.3240, or 

835.3280. If the antimicrobial reaches pass levels for 835.3110 (i.e., 70% removal of dissolved organic carbon 

(DOC) and 60% removal of theoretical oxygen demand (ThOD) or theoretical carbon dioxide (ThCO2) production 

for respirometric methods) in a 10-day window within the 28-day period of the test, registrants would be able to 

request that EPA waive the requirements for additional biodegradation tests. If the antimicrobial does not pass 

835.3110, the registrants would need to perform one of 835.3220, 835.3240, or 835.3280. 
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IV. Appendix A: Use Patterns – SHMG 

EPA Reg Number used for Max. Appl. Rate 

Formulation % Active 

Ingredient in End Use Formulation 

Use Category 

Use Site Treatment 

Site/Surfaces 

Method of Application 

Max Application/Rate 

57978-4 

Soluble Concentrate 50.0 

Materials Preservative 

Aqueous compositions 

Liquid Soaps, fabric cleaning and care products, water based cleaning products 

Not specified on label 

2-10 gallons 1000 gallons product beintreated (10005000 ppm) 

57978-4 

Soluble Concentrate 50.0 

Materials Preservative 

Aqueous compositions 

Waterborne coatings, polishes Water based adhesives 

Not specified on label 

2-10 gallons 1000 gallons product beintreated (10005000 ppm) 

57978-4 

Soluble Concentrate 50.0 

Materials Preservative 

Aqueous compositions 

Printing supplies Textile emulsions 

Not specified on label 

2-10 gallons 1000 gallons product beintreated (10005000 ppm)