KH· 

KELLER AND H :; MAN LLP 

Serving Bu.~iness through Low and S ·ienc/' 

1001 G Street, N.W. 

Suite 500 West 

Washington, D.C. 20001 

tel. 202.434.4100 

fax 202.434.4646 

April21, 2014 

Via Certified Mail 

OPPT IUR Submission Coordinator 

(7407M) Attention: Chemical Data 

Reporting Office of Pollution Prevention and 

Toxics U.S. Environmental Protection 

Agency 1200 Pennsylvania Ave., NW 

Washington, DC 20460-0001 

Writer's Direct Access 

Herbert Estreicher, J.D., Ph.D. 

(202) 434-4334 

es trei cher@kh I aw. com 

Re: REQUEST FOR EXEMPTION OF CORN STEEP LIQUOR FROM 

TSCA CHEMICAL DATA REPORTING (CDR) PROCESSING AND 

USE INFORMATION REPORTING REQUIREMENTS IN 2016 

Dear Sir or Madam: 

The Com Refiners Association (CRA) hereby requests the U.S. Environmental Protection 

Agency (EPA) to exempt com steep liquor (CASRN 66071-94-1) from the Toxic Substances 

Control Act (TSCA) Chemical Data Reporting (CDR) processing and use reporting requirements 

(Part III ofthe reporting form, Form U) pursuant to 40 C.F.R. 711.15(b)(2)(iii). Com steep liquor 

is predominantly used in animal feed and is of low risk to human health and the environment. 

I BASIS FOR PETITION 

EPA regulations at 40 C.F .R. § 711.15(b )(2)(iii) permit any person to request that the 

EPA amend the list of substances of "low current interest" that are partially exempt from CDR 

requirements, specifically from the processing and use reporting requirements contained in 40 

C.F .R. § 711.15(b )( 4 ). EPA states that in making the determination of whether this partial 

exemption should apply to a particular chemical substance, EPA will consider the totality of 

information available for the chemical substance in question, including but not limited to, certain 

enumerated considerations at 40 C.F .R. § 711.15(b )(2)(ii). 

The supporting attachments to this petition address each of the six exemption 

considerations for com steep liquor. Most importantly, our petition demonstrates that there is 

"low current interest" in CDR processing and use data for this product because it is of low 

potential human and environmental risk, is comprehensively regulated by other state and federal 

agencies, in particular the U.S. Food and Drug Administration, has a long history of safe use in 

both food and non-food products, and offers great promise for environmentally beneficial and 

sustainable alternatives to traditional synthetic chemistry. 

Washington, D.C. Brussels San Francisco Shanghai ~~------ ====---------------- This document was delivered electronically. www.khlaw.com 
KELLER AND HECKMAN LLP 

OPPT IUR Submission Coordinator 

April21 , 2014 

Page 2 

Based on these and the other considerations discussed below, we are confident that the 

EPA will conclude that these substances should be added to the list of CDR partially exempt 

substances. 

II TSCA REGULATED USES 

According to the CDR reports the TSCA regulated uses include corrosion inhibitors and 

anti-scaling agents. 

Even though the subject request is to partially exempt com steep liquor for the 2016 CDR 

reporting cycle, the Coalition requests that the EPA provide its response to this petition within 

the 120 days contemplated under 40 C.P.R. 711.15(b)(2)(iii)(A). The Coalition has a number of 

other food related substances for which it intends to submit similar requests and is anxious to 

receive the Agency's feedback on its general approach as reflected in the subject petitions 

Enclosures 

This document was delivered electronically. 

Sincerely, 

Herbert Estreicher 

Partner 
CDR Petition for Certain Food-Use Substances 

40 C.F.R. § 711.415(b)(2)(ii)(A) Criterion Information 

(Whether the chemical qualifies or has qualified in past IUR collections for the reporting of the 

information described in§ 711.15(b)(4)). 

Publicly available information on the 1986-2006 IUR database and the 2012 CDR database was 

searched for com steep liquor to determine whether the substance meets the criteria of "whether the 

chemical qualifies or has qualified in past IUR collections for the reporting of information described 

in §711.15(b )( 4 ). " See 40 C.F .R. § 711.15(b )(2)(ii)(A). It was reported in the 2006 IUR. 

Processing and use data was provided by 10 companies in the 2012 CDR. The 2012 CDR volume 

was reported as 250 to 500 million lbs per year. Data reported to EPA for purposes ofiUR on a 

confidential basis is not necessarily reflected in this submission. The Agency is respectfully 

requested to review the IUR database for confidential data to supplement the data provided. 

This document was delivered electronically. 
CDR Petition for Certain Food-Use Substances 

40 C.F.R. § 711.415(b)(2)(ii)(B) Criterion Information 

(The chemical substance's chemical and physical properties or potential for 

persistence, bioaccumulation, health effects, or environmental effects (considered 

independently or together). 

Data are available to EPA for com steep liquor from the Assessment Plan for Com Steep 

Liquor, the IUCLID data set and the Technical Evaluation Report, Compiled by the Technical 

Services Branch for the USDA National Organic Program which are provided as an appendix 

to this submission. 

The following provides a summary of the data from these sources. 

Data Available on Corn Steep Liquor (CASRN 66071-94-1) 

1) Substance identity profile 

a. Substance identifiers 

IUPAC name: Com, steep liquor 

CAS name: Com, steep liquor 

Other names: Com steepwater, light steepwater, heavy 

steepwater, condensed fermented com 

extractives 

CASRN: 66071-94-1 

EC number: 266-113-4 

Com steep liquor is a mixture of soluble 

Molecular formula: protein, amino acids, carbohydrates, 

organic acids (e.g., lactic acid), vitamins, 

and minerals. 

Representative Corn Steep Liquor Composition* 

Percent Percent 

Major Component Composition Composition 

(Wet Basis) (Dry Basis) 

Crude Protein" 25.1 46.5' 

Water 46.0 0.0 

Lactic Acid 13.9 25.8 

Ash 9.2 17.0 

Phytic Acid 4.2 7.8 

Reducing Sugars (as dextrose) 1.4 2.5 

Fat 0.2 0.4 

"Includes nitrogen content of 7.5% of total composition on dry basis 

*Source: Com Refiners Association member company data 

This document was delivered electronically. 
b. Physical properties' 

Physical State Liquid 

Melting Point Not applicable, com steep liquor is a liquid 

Boiling Point 1 00 - 1 04 degrees Centigrade 

Density 1.2 to 1.4g/cmj 

Vapor Pressure 17.5 mm, 20 degrees Centigrade 

Explodability not explosive 

Solubility Soluble in water 

Oxidizer Not an oxidizer 

c. Manufacturing 

As described in the Assessment Plan, com steep liquor is a byproduct of 

the initial stages of wet milling of com. Steeping of com (i.e., soaking in 

water) aids in the separation the various components of com such as 

starch and nutrients. Corn is normally steeped in stainless steel drums 

holding from 3,000-25,000 bushels of corn. Approximately 5-9 gallons 

of water per bushel of com is added to the tank. The water originates 

elsewhere in the wet milling process where it has already obtained some 

soluble com matter. The temperature of the water is maintained at 45-

54.C by heating the water as it is recirculated or by using a heat 

exchanger Immediately before adding the water to drums, an aqueous 

source of sulfur dioxide is added to the water to a concentration of 0.1-

0.2%. In water, these sources of sulfur dioxide form sulfurous acid, 

which controls fermentation and softens the com kernel to aid in the 

separation of the corn products. Most of the sulfurous acid is absorbed 

by the corn kernels so that after ten hours the concentration of sulfurous 

acid in the steepwater is lowered to 0.01 %. The corn is steeped for 

anywhere between 22-50 hours, while the CSL is moved through six to 

twelve successive steeping tanks. The CSL is initially added to the tank 

with the oldest corn so that it is in contact with the highest concentration 

of the sulfurous acid. The water is then moved to fresher com so that the 

oldest CSL is in contact with the freshest corn. Approximately one third 

of the water is absorbed by the corn during the steeping, and the other 

two-thirds is withdrawn from the steeping system as light steepwater 

that contains between 6-9% solids by weight. The light steepwater is 

then evaporated until it contains 40-60% solids. The resulting CSL may 

be further processed by downstream users to meet their own 

specifications. 

d. Uses 

According to the IUCLID data set, the primary use of corn steep liquor 

is as a nutrient additive in the feed for ruminant animals in which it 

provides a natural source of proteins, amino acids, vitamins, reducing 

sugars (e.g., dextrose), organic acids (e.g., lactic acid), minerals, and 

This document was delivered electronically. 
other elemental nutrients. Some com steep liquor is used in the 

production of acetic acids, food acids, and fermentation processes. 

Some com steep liquor has been used in the pharmaceutical industry in 

the production of intravenous solutions and drugs, most notably 

antibiotics (penicillin). A small amount of com steep liquor is uses in 

corrosion inhibitors and anti-scaling agents. 

2) Toxicological profile 

a. Human Toxicity 

While standard guideline mammalian toxicity studies are not available, many 

nutrition-related studies have been conducted over the years to show the safety of 

CSL in animals. CSL is used as a nutritive additive in a wide range of animal 

feeds for cattle, sheep, swine, dairy cows, and poultry. CSL has also been used to 

supplement feed used for pets, catfish farming, and honey bee production. No 

adverse effects have been observed in any of these studies. 

b. Ecological Toxicity and Environmental Fate 

Because of the natural derivation of CSL, specific guideline ecotoxicity studies 

are not available, nor are they necessary. CSL is not expected to exhibit toxicity 

to fish or other aquatic organisms. CSL consists of the water soluble components 

of com that has been soaked in water. These all-natural constituents are primarily 

crude proteins, amino acids, vitamins, reducing sugars, organic acids (e.g., lactic 

acid), and other trace elemental nutrients. The primary use of CSL is as a nutrient 

source additive in animal feeds, and has a long history of safe use. It should be 

noted that the available data for one component (lactic acid, which may make up 

10-25% of the CSL) have been summarized for the HPV Challenge program. 

These data indicate very low aquatic toxicity for this component, and provide 

supporting evidence for the overall toxicity of the CSL mixture. In addition, CSL 

is used in the production of acetic acid, other food acids, and in fermentation 

processes. Therefore, the material would not inhibit microorganism growth, and 

in fact, would serve as a nutrient source. 

CSL consists only of water soluble nutrients, it would be expected that it would 

be present largely in the water compartment in the environment. The individual 

components of the mixture are natural nutrients, so would rapidly be assimilated 

as an energy source in normal cellular processes. 

c. Exposure 

The primary use of CSL is as a nutrient for ruminant animals. CSL provides 

proteins, amino acids, minerals, vitamins, reducing sugars (such as dextrose), 

organic acids (in particular lactic acid), enzymes, and elemental nutrients such as 

nitrogen. The majority of CSL produced is immediately added to com gluten and 

fibrous materials for use as animal feed. The remaining CSL has several uses. It 

is mostly used as a liquid feed supplement for cattle, dairy cows, sheep, goats, 

This document was delivered electronically. 
and swine. In the chemical industry, com steep liquor is used in the production 

of acetic acid, food acids, and in fermentation processes. CSL is also used by the 

pharmaceuticals industry in the production of intravenous solutions and drugs, 

most notably antibiotics. 

Worker exposure to CSL during its manufacturing is limited by the automation 

of the steeping process. The water is piped into the steeping tanks and from one 

tank to another. While small amounts of inhalation are possible during the 

evaporation of water from the CSL, the vapor would contain mostly water as the 

solid fraction of the CSL would remain in the evaporation tanks. The low amount 

of sulfurous acid (0.01% or less) would not be a concern. Local exhaust 

ventilation is used to control mists. Further exposure to CSL could occur during 

the mixing of the CSL with com gluten to make animal feed, and during the 

packaging of com steep liquor for uses. Exposure during the mixing or 

packaging of CSL is mitigated by automation, and the resulting animal feed may, 

in fact, be introduced directly into trucks for delivery to farms where it may be 

fed to animals immediately or placed in storage. Exposure might also be possible 

during the cleaning of equipment used in the manufacturing process. 

Exposure during consumer use could occur when giving animals pre-mixed feeds 

or supplements containing CSL, or during pouring of liquid feed supplements 

into feed mixers for subsequent distribution to animals. Exposure is not likely to 

cause adverse effects, since all components of com steep liquor are natural to the 

com except for the small amount of sulfurous acid. This small amount is unlikely 

to cause any adverse effects as it is an approved preservative for food. Other user 

exposures could occur when com steep liquor is used in the manufacturing of 

chemicals and drugs. Exposure during these uses would be mitigated by 

automation and normal laboratory personal protective equipment, such as gloves 

and safety glasses, and good industrial hygiene practices (MSDS sheets). 

3) Other information 

The Assessment Plan for Com Steep Liquor, the IUCLID data set and the Technical 

Evaluation Report, Compiled by the Technical Services Branch for the USDA National 

Organic Program are attached to this document. 

This document was delivered electronically. 
CDR Petition for Certain Food-Use Substances 

40 C.F.R. § 711.15(b)(2)(ii)(C) Criterion Information 

(The information needs of EPA, other federal agencies, tribes, states, and local 

governments, as well as members of the public). 

Com steep liquor has not been the subject of or considered for information collection 

requirements by EPA under TSCA (other than the TSCA IUR), the Interagency Testing 

Committee (ITC), or the Agency for Toxic Substances and Disease Registry (A TSDR). Com 

steep liquor has not been or is it the subject of any proposed or final regulation by the EPA under 

the following programs: 

TSCA 4 Test Rules 

TSCA 4(F) Required Actions 

TSCA 5(A)(2) Chemicals Subject to Significant New Use Rules (SNURS) 

TSCA 5(B) Data Gathering Requirements 

TSCA 5(E) Testing Consent Order Chemicals 

TSCA 5(F) Immediately Effective Rules 

TSCA 6(A) Hazardous Chemical Control Rules 

TSCA 8(A) Toxic Substances Subject to Reporting Rules on Production 

TSCA 8(A) CAIR Comprehensive Assessment Information Rules 

TSCA 8(A) Pair Preliminary Assessment Information Rules 

TSCA 8(C) Records of Allegations of Significant Adverse Reactions 

TSCA 8(D) Health and Safety Reporting Rules 

TSCA 8(D) Health and Safety Reporting Rules Termination 

TSCA 12(B) Notices of Export 

SARA 313 Chemicals Regulated Under §313 ofEPCRA 

See http://www .epa.gov/ opptintr/CORR/index.htm. 

The petitioning associations are not aware of any unmet information needs of the EPA, other 

federal agencies, tribes, states, local governments, or members of the public in light of: 

0 FDA regulatory clearances currently available for these petitioned substances which 

acknowledge that their use in food applications is safe; 

0 The extensive data on the substances published on the ECHA website. 

http://apps.echa.europa.eu/registered/data/dossiers/DISS-9fdcaf46-0f58-4e27-e044-

00 144f67d031/DISS-9fdcaf46-0f58-4e27 -e044-00 144f67d031 DISS-9fdcaf46-0f58-4e27 -e044-

00 144f67d031 .html 

CRA would like the opportunity to respond and submit additional information needs identified 

by EPA during the petition process, if any, prior to EPA's final action on the petition request. 

This document was delivered electronically. 
CDR Petition for Certain Food-Use Substances 

40 C.F.R. § 711.15(b)(2)(ii)(D) Criterion Information 

(The availability of other complementary risk screening information). 

The following table provides the status of the petitioned substances on the Annex IV exemption 

determinations by the European Union for the REACH program, under REACH registration, 

under the voluntary EPA High Production Volume (HPV) Chemical Challenge Program, and in 

connection with EPA safety determinations for low toxicity pesticide inerts. 

EU BU !Low 

eAs Gl1em ca lnd~ Name REA.CH REACH HPV Risk 

~umber List Inert Exempri,on •I Registered !Listing 

' 

66071-94-1 Corn Steep Liquor No Yes '4 4B 

The categorization for the 1990 and 1994 HPV lists are as follows: 

0 =Chemical is within the scope of the HPV Challenge Program and may be sponsored. 

1 = Chemical is not considered a candidate for testing under the HPV Challenge Program, based 

on preliminary EPA review indicating that testing using the SIDS base set would not further 

EPA's understanding ofthe chemical's properties. 

2 = Chemical is otherwise being handled under the Organization for Economic Co-operation 

and Development (OECD) Screening Information Data Set (SIDS) Program. 

3 =Chemical is not subject to the HPV Challenge Program because it is a polymer or inorganic 

substance. 

4 =A company or consortium has clearly indicated to and has had confirmed by ICCA its 

sponsorship ofthis chemical in the Global HPV Initiative ofthe International Council of 

Chemical Associations, and all information essentially equivalent to a Full Commitment under 

the HPV Challenge Program (i.e., chemical name, CAS number, start year for each chemical, 

technical contact person and telephone number) has been provided to EPA. 

The key to EPA's Pesticide and Inert listings are as follows: 

1 =Inert Ingredients of Toxicological Concern 

2 =Potentially Toxic Inert Ingredients/High Priority for Testing Inerts 

3 = Inerts of Unknown Toxicity 

4A = Minimal Risk Inert Ingredients 

4B = Inerts which have sufficient data to substantiate they can be used safely in pesticide 

products 

This document was delivered electronically. 
CDR Petition for Certain Food-Use Substances 

40 C.F.R. § 711.15(b)(2)(ii)(E) Criterion Information 

(The availability of comparable processing and use information) 

Processing and use ofthese substances is well characterized. TSCA-regulated exposures 

associated with these substances are comparable to, or less significant than, the food-use 

exposures associated with these substances which have already been shown to be "safe". More 

specific processing and use information is included in the data summaries at that section of this 

petition that discusses (B) Criterion Information. 

This document was delivered electronically. 
CDR Petition for Certain Food-Use Substances 

40 C.F.R. § 711.15 (b)(2)(ii)(F) Criterion Information 

(Whether the potential risks of the chemical substance are adequately managed by EPA or 

another agency or authority) 

CRA is not aware of any information to suggest that these agencies are inadequately managing 

the safe use of Com Steep Liquor. 

The manufacturing and use of these substances primarily fall within the jurisdiction and 

authority ofthe FDA. However, the EPA, the Occupational Safety and Health Administration 

(OSHA), the National Institute for Occupational Safety and Health (NIOSH), and the Consumer 

Product Safety Commission (CPSC) regulate the manufacture and use of the petitioned 

substances as well. In addition, state environmental protection agencies have authority over 

facilities within their jurisdictions. 

As previously indicated, food uses of the petitioned components far exceed TSCA-regulated 

uses. Activities related to TSCA-regulated processing and use of the petitioned substances will 

also result from food-processing activities. Indeed, the same production equipment, processing 

techniques, and feed stocks may be used. These activities and their resulting environmental 

effects are already controlled adequately under other regulatory regimes. With respect to EPA 

programs specifically, human and environmental exposures are adequately controlled through 

existing regulatory programs such as the Clean Water Act, the Clean Air Act, and the Resource, 

Conservation and Recovery Act, and the Spill Prevention, Control and Countermeasures 

(SPCC) Program. Relevant FDA regulations for the petitioned substances are provided below. 

Petitioned Substance 

Com Steep Liquor 

This document was delivered electronically. 

CASRN 

66071-94-1 

FDA Regulation at 21 C.F.R. 

73.275 -Dried algae meal 
Rr:c= ~''Ell C '~-·' ·_· iC 

2008 Nt'\ Y 2 9 h~i 7: 4 9 

201-16714A 

Assessment Plan for Corn Steep Liquor 

(CAS #66071-94-1) 

in Accordance with the USEP A High Production 

Volume Chemical Challenge Program 

Prepared for: 

The Corn Refmers Association 

RevisedApril 24, 2008 

Keller and Heckman LLP 

1001 G Street, NW 

Washington, DC 20001 

www.khlaw.com 

-- - --------- -----
TABLE OF CONTENTS 

EXECUTIVE SUMMARY .... .. ....................................................................... .... ............... 2 

INTRODUCTION ................................ .................................................. ................ ............ 3 

IDENTIFICATION OF SPONSORED CHEMICAL ................................................. ....... 4 

A. Chemical Structure 

B. Production Process 

C. Use Patterns and Exposure Potential 

COLLECTION OF UNPUBLISHED AND PUBLISHED DATA .. .. .. ........................... ... 6 

EVALUATION OF DATA FOR QUALITY AND ACCEPTABILITY ........................... 6 

SUMMARY OF AVAILABLE DATA ................................................................ .. ............ 6 

Physical-Chemical Properties .. .................................................................................... 7 

Environmental Fate and Transport .............................. ...................................... .. ......... 8 

Ecotoxicity ... ............................... .. ............. .. ................. ...................................... ......... 8 

Toxicity ........ .. ..................................................... .................... ....... ......................... ..... 9 

Evaluation ofData Completeness ...................................... ............... .......................... 9 

SUMMARY OF CORN STEEP LIQUOR PROPERTIES ................... ..... ............... ..... .. .. 9 

CONCLUSIONS .................... ..................................... .............................. ... ..................... .. 9 

REFERENCES ........................ .. ................................................................... .. ..... ............. 10 

Table I. 

Table 2. 

LIST OF TABLES 

Representative Corn Steep Liquor Composition 

Physical-Chemical Properties 

LIST OF APPENDICES 

Appendix A. Summary of Literature and Database Searches 

Appendix B. 2006 IUCLID Data Set 
EXECUTIVE SUMMARY 

The Corn Refiners Association (CRA) is sponsoring Corn Steep Liquor (CSL) in the US High 

Production Volume (HPV) Challenge program. The primary use ofCSL is as a nutrient for 

ruminant animals. CSL provides proteins, amino acids, minerals, vitamins, reducing sugars 

(such as dextrose), organic acids (in particular, lactic acid), enzymes, and elemental nutrients 

(such as nitrogen). CRA assembled and reviewed the available public and private toxicological 

data, and developed an assessment plan for the sponsored chemical. 

CSL is a viscous liquid mixture consisting entirely of the water soluble components of corn 

steeped in water. All constituents are naturally-occurring, nutritive materials such as crude 

proteins, amino acids, vitamins, reducing sugars (e.g., dextrose), organic acids (e.g., lactic acid), 

minerals, and other elemental nutrients. CSL will transport mainly in the water, and its 

constituents are easily assimilated into normal cell metabolism. No ecological, mammalian or 

human toxicity would be expected from these natural nutritive materials. 

Worker exposure to CSL during its manufacturing is limited by the automation ofthe steeping 

process, use of standard personal protective equipment, and other engineering controls. 

Exposure during consumer use could occur when giving animals pre-mixed feeds or supplements 

containing CSL, or during pouring of liquid feed supplements into feed mixers for subsequent 

distribution to animals. Adequate protective equipment is recommended during these uses. In 

any case, exposure is not likely result in adverse effects since all CSL components are natural to 

the corn except for the small amount of sulfur dioxide. Sources of aqueous sulfur dioxide (e.g., 

sulfur dioxide, sodium bisulfite) are approved preservatives for food and are unlikely to cause 

any adverse effects. Other user exposures could occur when CSL is used in the manufacturing of 

chemicals and drugs. Exposure during these uses would be mitigated by automation and normal 

laboratory personal protective equipment. 

Based on the long and established history of safe use as a nutrition source in animal feed, the 

Corn Refiners Associa~ion is not proposing to conduct additional testing on this natural water 

soluble extract of corn. 

2 
INTRODUCTION 

The High Production Volume (HPV) Challenge Program is a voluntary initiative ofthe US 

chemical industry to complete hazard data profiles for approximately 2800 HPV chemicals as 

identified on the US Environmental Protection Agency's (USEPA) 1990 Toxic Substances 

Control Act (TSCA) Inventory Update Rule (IUR). In the US, HPV chemicals are those that are 

manufactured or imported in quantities greater than 1 million pounds per year. The hazard data 

to be provided in the program are those that meet the requirements of the Screening Information 

Data Set (SIDS) Program (OECD 1997). SIDS, which has been internationally agreed to by 

member countries of the Organization for Economic Cooperation and Development (OECD), 

provides the basic screening data needed for an initial assessment of the physical-chemical 

properties, environmental fate, and adverse human and environmental effects of chemicals. The 

information for completing the SIDS can come from existing data or may be generated as part of 

the HPV Challenge Program. Once the available studies are identified or conducted, "robust 

summaries" are prepared. 

The USEPA, industry, and non-governmental organizations (NGOs) are unified in their 

commitment to minimize the numbers of animals tested in the HPV Challenge Program 

whenever it is scientifically justifiable (USEPA 1999a, 2000). Therefore, this test plan evaluates 

all of the existing data for the sponsored chemical in an effort to adequately characterize the 

health and environmental hazard while reducing the number of animals required for testing. 

The Corn Refiners Association (CRA) has agreed to assemble and review avail,able public and 

private toxicological data, develop and provide an assessment plan for the sponsored chemical 

and conduct additional research, including testing when necessary, for corn steep liquor (CSL). 

CSL is primarily used as a nutrient in animal feed. The participating member companies of the 

Corn Refiners Association are: 

Archer Daniels Midland Company 

Cargill, Inc. 

Corn Products International, Inc. 

National Starch and Chemical Company 

Penford Products Company 

Raquette America, Inc. 

Tate & Lyle Ingredients Americas, Inc. 

This assessment plan is the result of the CRA's efforts and provides a summary and analysis of 

the available data, and identifies any data gaps in the SIDS data profile. The first section of this 

assessment plan provides an identification of the sponsored chemical, including its structure, 

production process, and use pattern. Following that are sections on the process used to collect 

the unpublished and published data, and how those data were evaluated for quality and 

acceptability. This is followed by a discussion ofthe physical-chemical properties, 

environmental fate and transport, ecotoxicity, and mammalian toxicity data as summarized in the 

accompanying robust summary document. Finally, conclusions regarding data availability and 

identification of data gaps in the SIDS profiles for the sponsored chemical are presented. 

3 
IDENTIFICATION OF SPONSORED CHEMICAL 

A. Chemical Structure 

The chemical being sponsored is corn steep liquor (CAS #66071-94-1). Corn steep liquor (CSL) 

is also known by several synonyms including corn steepwater, light steepwater, and heavy 

steepwater. CSL is a mixture consisting of the water soluble extracts of corn soaked (steeped) in 

water. In fact, approximately 50% ofCSL is water, with the remainder composed entirely of 

natural nutritive "building blocks" such as crude proteins, amino acids, minerals, vitamins, 

reducing sugars, organic acids, enzymes and other elemental nutrients. While the actual percent 

composition varies slightly between member companies, Table 1 lists the average composition of 

the major constituents ofCSL. 

. 

Table 1. Representative Corn Steep Liquor Composition* 

Percent Percent 

Major Component Composition Composition 

(Wet Basis) (Dry Basis) 

Crude Protein" 25.1 46.5 

Water 46.0 0.0 

Lactic Acid 13.9 25.8 

Ash 9.2 17.0 

Phytic Acid 4.2 7.8 

Reducing sugars (as dextrose) 1.4 2.5 

Fat 0.2 0.4 

Total 100.0 100.0 

1\ Includes nitrogen content of7.5 percent of total composition on dry basis. 

* Source: Corn Refiners Association member company data. 

CSL is very low in fat and fiber, which makes it an excellent nutritive source for animal feed. 

Constituents of ash include magnesium, phosphorus, potassium, calcium, chlorine, sodium and 

sulfur. CSL is also a good source for all amino acids, important vitamins and nitrogen 

compounds, and essential trace elements such as iron, manganese, boron, copper, and zinc. All 

of these constituents provide natural nutrition for normal cell metabolism and are not a cause for 

concern. 

B. Production Process 

Corn steep liquor is a byproduct of the initial stages of wet milling of corn. Steeping of corn 

(i.e., soaking i'n water) aids in the separation the various components of con1 such as starch and 

nutrients. Corn is normally steeped in stainless steel drums holding from 3,000-25,000 bushels 

of corn (CRA 2002; White and Johnson 2003). Approximately 5-9 gallons of water per bushel 

of corn is added to the tank (Liggett and Koffler 1948; White and Johnson 2003 ). The water 

4 
originates elsewhere in the wet milling process where it has already obtained some soluble corn 

matter. The temperature ofthe water is maintained at 45-54°C by heating the water as it is 

recirculated or by using a heat exchanger (Liggett and Koffler 1948; CRA 2006a; White and 

Johnson 2003). Immediately before adding the water to drums, an aqueous source of sulfur 

dioxide is added to the water to a concentration of0.1-0.2% (Liggett and Koffler 1948; White 

and Johnson 2003). In water, these sources of sulfur dioxide form sulfurous acid, which controls 

fermentation and softens the corn kernel to aid in the separation of the corn products. Most of 

the sulfurous acid is absorbed by the corn kernels so that after ten hours the concentration of 

sulfurous acid in the steep water is lowered to 0.01% (Liggett and Koffler 1948). 

The corn is steeped for anywhere between 22-50 hours, while the CSL is moved through six to 

twelve successive steeping tanks. The CSL is initially added to the tank with the oldest corn so 

that it is in contact with the highest concentration ofthe sulfurous acid. The water is then moved 

to fresher corn so that the oldest CSL is in contact with the freshest corn. Approximately onethird of the water is absorbed by the corn during the steeping, and the other two-thirds is 

withdrawn from the steeping system as light steepwater that contains between 6-9% solids by 

weight. The light steepwater is then evaporated until it contains 40-60% solids. The resulting 

CSL may be further processed by downstream users to meet their own specifications (White and 

Johnson 2003; Budavari 1996). 

C. Use Patterns and Exposure Potential 

The primary use of CSL is as a nutrient for ruminant animals. CSL provides proteins, amino 

acids, minerals, vitamins, reducing sugars (such as dextrose), organic acids (in particular lactic 

acid), enzymes, and elemental nutrients such as nitrogen. The majority of CSL produced is 

immediately added to corn gluten and fibrous materials for use as animal feed. The remaining 

CSL has several uses. It is mostly used as a liqui·d feed supplement for cattle, dairy cows, sheep, 

goats, and swine (White and Johnson 2003; Liggett and Koffler 1948; CRA 2006b). In the 

chemical industry, corn steep liquor is used in the production of acetic acid, food acids, and in 

fermentation processes. CSL is also used by the pharmaceuticals industry in the production of 

intravenous solutions and drugs, most notably antibiotics (CRA 2006b ). In fact, CSL was 

instrumental to the large-scale production of penicillin in the 1940s (USDA 2006). In 2005, a 

total of 1,282,614,000 lbs ofCSL was shipped in the United States, representing 2.3% of wet 

milled corn products (CRA 2006c). 

Worker exposure to CSL during its manufacturing is limited by the automation of the steeping 

process. The water is piped into the steeping tanks and from one tank to another. While small 

amounts of inhalation are possible during the evaporation of water from the CSL, the vapor 

would contain mostly water as the solid fraction of the CSL would remain in the evaporation 

tanks. The low amount of sulfurous acid (0.01% or less) would not be a concern. Local exhaust 

ventilation is used to control mists. Further exposure to CSL could occur during the mixing of 

the CSL with corn gluten to make animal feed, and during the packaging of corn steep liquor for 

uses. Exposure during the mixing or packaging ofCSL is mitigated by automation, and the 

resulting animal feed may, in fact, be introduced directly into trucks for delivery to farms where 

it may be fed to animals immediately or placed in storage (Linton and Hussar 1989; Westburg 

5 
2006). Exposure might also be possible during the cleaning of equipment used in the 

manufacturing process. 

Exposure during consumer use could occur when giving animals pre-mixed feeds or supplements 

containing CSL, or during pouring of liquid feed supplements into feed mixers for subsequent 

distribution to animals (Linton and Hussar 1989). Exposure is not likely to cause adverse 

effects, since all components of corn steep liquor are natural to the corn except for the small 

amount of sulfurous acid. This small amount is unlikely to cause any adverse effects as it is an 

approved preservative for food (FDA 2002). Other user exposures could occur when corn steep 

liquor is used in the manufacturing of chemicals and drugs. Exposure during these uses would 

be mitigated by automation and normal laboratory personal protective equipment, such as gloves 

and safety glasses, and good industrial hygiene practices (MSDS sheets). 

COLLECTION OF UNPUBLISHED AND PUBLISHED DATA 

Corn Refiners Association member companies contributed available in-house information related 

to physical-chemical properties, environmental fate and transport, ecotoxicity, and mammalian 

toxicity for CSL. CRA member companies also provided information related to the use patterns 

and composition of the CSL mixture. To supplement the industry data, literature searches were 

conducted of on-line databases (e.g., Hazardous Substances Databank [HSDB], Registry of 

Toxic Effects of Chemical Substances [RTECS], and the USEPA's ECOTOX database), standard 

scientific data compendia (e.g., CRC Handbook of Chemistry and Physics and The Merck Index), 

and other published sources (e.g., International Uniform Chemical Information Database 

[IUCLID]). A summary ofthe literature and database sources searched can be found in 

Appendix A. 

EVALUATION OF DATA FOR QUALITY AND ACCEPTABILITY 

The collected data were reviewed for quality and acceptability following the USEPA and OECD 

SIDS guidance (USEPA 1999b; OECD 1997) and the systematic approach described by 

Klimisch et al. (1997). These methods include consideration ofthe reliability, relevance, and 

adequacy of the data in evaluating their usefulness for hazard assessment purposes. The 

Klimisch et al. (1997) approach specifies four categories of reliability for describing data 

adequacy. These are: 

I. Reliable without Restriction: Includes studies or data complying with Good 

Laboratory Practice (GLP) procedures, or with valid and/or internationally accepted 

testing guidelines, or in which the test parameters are documented and comparable to 

these guidelines. 

2. Reliable with Restrictions: Includes studies or data in which test parameters are 

documented but vary slightly from testing guidelines. 

6 
3. Not Reliable: Includes studies or data in which there are interferences, or that use 

non-relevant organisms or exposure routes, or which were carried out using 

unacceptable methods, or where documentation is insufficient. 

4. Not Assignable: Includes studies or data in which insufficient detail is reported to 

assign a rating, e.g., listed in abstracts or secondary literature. 

Common practice is that only those studies which are deemed reliable for the current HPV 

Challenge Program purposes are included in the data set. In general, reliable studies include 

both categories rated 1 (reliable without restriction) and 2 (reliable with restrictions). Studies 

rated 3 (not reliable) were not used. Studies rated 4 (not assignable) were used when 

professional judgment deemed it appropriate as part of a weight-of-evidence approach. 

Because CSL is a mixture consisting of the water soluble crude proteins, amino acids, reducing 

sugars and other natural nutrients used in animal feed, and therefore, is of very low concern, 

formal guideline-based toxicity studies are not available. Therefore, the robust summary dossier 

(IUCLID Data Set) for CSL primarily summarizes information related to the long history of safe 

nutritional supplement use of CSL. A previous IUCLID Data Set for CSL was prepared by one 

of the member companies in 2000; this data set was updated and additional information added 

for the current HPV Challenge submission. The robust summary dossier for corn steep liquor is 

attached as Appendix B and should be used in conjunction with this assessment plan. 

SUMMARY OF AVAILABLE DATA 

The following discussion reviews the available data identified for each of the four major data 

areas: physical-chemical properties, environmental fate and transport, ecotoxicity, and 

mammalian toxicity. 

Physical-Chemical Properties 

Physical-chemical property data are available primarily from the IUCLlD 2000 data set for CSL 

and from member company MSDS and other technical data sheets. Data were collected from all 

six member companies and the ranges are summarized in Table 2. All physical-chemical 

properties have a reliability of 4 (not assignable) because the original reports were not available 

for review. 

7 
Table 2. Physical-Chemical Properties 

Endpoint Value Comment 

Form Liquid Viscous 

Color Tan to brown 

Odor Sharp 

Melting Point Not applicable Liquid at room 

temperature 

Boiling Point 100-101 oc 

Conductivity 2.5 J,.lmoh 

Specific Gravity 1.15-1.25 

Density 1.2-1.4 g/cm3 

Vapor Pressure 17.5 mm Hg at 25°C Equal to 23.3 hPa 

Partition Coefficient Not available (Log Kow) 

Water Solubility Soluble 

CSL is a viscous liquid with a boiling point essentially that of water. Because CSL results from 

the steeping (soaking) of corn in water, all ofthe individual constituents ofthe mixture are 

highly water soluble nutrients. Because of this high solubility, no bioaccumulation is expected, 

though CSL does provide valuable nutrients that are naturally used by organisms for normal 

cellular subsistence and metabolism. 

Environmental Fate and Transport 

Traditional environmental fate data are important for demonstrating the primary mechanism or 

mechanisms of degradation and how a material's properties affect its transport in the 

environment. For organic chemicals, fate is generally a function of the breakdown of 

compounds into smaller constituents by biological degradation. Other breakdown mechanisms 

that may be important are photolysis and hydrolysis. These breakdown mechanisms are 

necessarily dependent on what environmental compartment (air, water, soil, sediment) to which 

the chemicals are distributed. Fugacity modeling is normally used to estimate the relative 

percentage of chemicals that will partition to various compartments at steady state. However, 

because CSL consists only ofwater soluble nutrients, it would be expected that it would be 

present largely in the water compartment. In addition, the individual components of the mixture 

are natural nutrients, so would rapidly be assimilated as an energy source in normal cellular 

processes. No additional environmental fate studies are warranted. 

Ecotoxicity 

Because ofthe natural derivation ofCSL, specific guideline ecotoxicity studies are not available, 

nor are they necessary. CSL is not expected to exhibit toxicity to fish or other aquatic 

organisms. CSL consists of the water soluble components of corn that has been soaked tn 

water. These all-natural constituents are primarily crude proteins, amino acids, vitamins, 

reducing sugars, organic acids (e.g., lactic acid), and other trace elemental nutrients. The 

8 
primary use of CSL is as a nutrient source additive in animal feeds, and has a long history of safe 

use. It should be noted that the available data for one component (lactic acid, which may make 

up 10-25% ofthe CSL) have been summarized for the HPV Challenge program. These data 

indicate very low aquatic toxicity for this component, and provide supporting evidence for the 

overall toxicity of the CSL mixture. 

In addition, CSL is used in the production of acetic acid, other food acids, and in fermentation 

processes. Therefore, the material would not inhibit microorganism growth, and in fact, would 

serve as a nutrient source. 

No further ecological toxicity studies are being proposed. 

Toxicity 

While standard guideline mammalian toxicity studies are not available, many nutrition-related 

studies have been conducted over the years to show the safety of CSL in animals. CSL is used as 

a nutritive additive in a wide range of animal feeds for cattle, sheep, swine, dairy cows, and 

poultry. CSL has also been used to supplement feed used for pets, catfish farming, and honey 

bee production (Pressick 1985). No adverse effects have been observed in any ofthese studies. 

No further mammalian toxicity studies are necessary. 

Evaluation of Data Completeness 

CSL has a long history (over 100 years) of safe use as a nutrient additive in animal feed and as a 

nutrient source in fermentation processes. Because ofthe lack of toxicity concerns and the 

nutritional benefits of CSL, standard guideline studies have not been completed. The safe use of 

CSL has been adequately established and therefore the CRA is not proposing to conduct 

additional guideline studies at this time. 

SUMMARY OF CORN STEEP LIQUOR PROPERTIES 

Corn steep liquor is a viscous liquid mixture consisting entirely ofthe water soluble components 

of corn steeped in water, along with a small amount of sulfurous acid ( <0.0 I%). All constituents 

are naturally occurring nutritive materials such as crude proteins, amino acids, vitamins, 

reducing sugars (e.g., dextrose), organic acids (e.g., lactic acid), minerals, and other elemental 

nutrients. CSL will transport mainly in the water, and its constituents are easily assimilated into 

normal cell metabolism. No ecological, mammalian, or human toxicity would be expected from 

these natural nutritive materials. 

CONCLUSIONS 

CSL has a long history of safe use as an added source of nutrition in animal feed, in fermentation 

processes, and in antibiotic production. Because CSL consists of natural nutritive materials, 

there is very low toxicity concern. The CRA is not proposing to conduct additional testing on 

this natural water soluble extract of corn. 

9 
REFERENCES 

ADM. 2002. Material Safety Data Sheet: Corn Steepwater. Archer Daniels Midland Company, 

Decatur, IL. August 2002. 

Budavari, S. (ed.). 1996. Merck Index (121

h edition), Merck Research Laboratories, Whitehouse 

Station, NJ. 

Butzen, S., and Hobbs, T. 2002. Corn processing III: wet milling. Crop Insights, 12(15): 1-6. 

Cargill Corn Milling. 1997. Material Information Sheet: Steepwater. Cargill Corn Milling, 

Blair, NE. 

Corn Products U.S. 2004. Material Safety Data Sheet: Corn Steepwater. Corn Products U.S., 

Westchester, IL. 

CRA. 2002. The Process (Step-by-step): Steeping. Corn Refiners Association. Available at 

http://www.corn.org/web/steep.htm. 

CRA. 2006a. Corn Wet Milled Feed Products (41

h edition), Corn Refiners Association, 

Washington, DC. 

CRA. 2006b. Tapping the Treasure. Corn Refiners Association. Available at 

http://www.corn.org/Tapping2006.pdf. 

CRA. 2006c. Shipment of Products of the Corn Refining Industry- 2005. Corn Refiners 

Association. Available at http://www.corn.org/web/shipprod.htm. 

FDA. 2002. Food Additives- Alphabetical List. Food and Drug Administration. Available at 

http://www.foodstandards.gav.au/ srcfiles/new alpha list 0902.pdf. 

IUCLID Data Set. CAS No. 66071-94-1. Corn Steep Liquor. February 2000. Year 2000 CDROM Edition. 

Klimisch, H.-J., Andreae, M., and Tillmann, U. 1997. A systematic approach for evaluating the 

quality of experimental toxicological and ecotoxicological data. Regul. Toxicol. Pharmacal. 

25:1-5. 

Liggett, W.R., and Koffler, H. Corn Steep Liquor in Microbiology. Bacterial. Rev., 12(4): 297-

311, December 1, 1948. 

Linton, J.H., and Hussar, N. 1989. Animal Feed Supplement Prepared from Wet Corn Bran and 

Corn Steep Liquor. United States Patent 4,859,485. Aug. 22, 1989. 

10 
National Starch and Chemical. 2005. Material Safety Data Sheet: Heavy Steep Water. 

National Starch and Chemical Company, Bridgewater, NJ. 

OECD. 1997. SIDS Manual (third revision). Organization for Economic Cooperation and 

Development. July 1997. 

Penford Products Co. 2005. Material Safety Data Sheet: Heavy Steepwater. Penford Products 

Co., Cedar Rapids, lA. 

Pressick, J.C. 1985. To Prepare a Review on Corn Steepwater in Animal Feeding Showing its 

Long, Successful Feeding History, Safety and Efficacy. Internal report to the Corn Products 

Unit, Report No. 11337-7118, July-August 1985, pp. 1-26. 

Staley. 1991. Material Safety Data Sheet: Corn Steep Liquor. A. E. Staley Manufacturing Co, 

Decatur, IL. 

USDA. 2006. AES Timeline: The Rescue of Penicillin. United States Department of 

Agriculture. Available at http://www .ars.usda.gov /is/time) ine/penicillin.htm. 

USEPA. 1999a. HPV Chemical Human Health Testing: Animal Welfare Issues and 

Approaches. Guidance document dated February 1999. 

USEPA. 1999b. Determining the Adequacy of Existing Data. Draft guidance document dated 

February 10, 1999. 

USEPA. 1999c. Draft Guidance on Developing Robust Summaries. October 22, 1999. 

USEPA. 2000. Chemical Right to Know High Production Volume Challenge Program: Fact 

Sheet on Animal Welfare. July 2000. EPA 745-F-99-003. 

Westburg, J.A. 2006. Process for Manufactoring Animal Feed Supplements. United States 

Patent 7,045,165 B2. May 16, 2006. 

White, P. and Johnson, L.A., (eds.). 2003. Corn: Chemistry and Technology (2nd Edition), 

American Association of Cereal Chern ists. 

11 
Appendix A: Summary of Literature and Database Searches 

Sites Searched: 

1. STN 

a. CAPLUS 

i. "corn steep liquor"- over 4295 hits 

11. "corn steep liquor" and "composition"- 57 hits, several good, however, 

these were in foreign languages. Some abstracts of studies of using corn 

steep liquor to grow antibiotics. 

iii. "corn steep liquor" and "environment"- 44 hits, a few references to using 

corn steep liquor in environmentally benign de-icing formulas. 

iv. "corn steep liquor" and "human health"- 0 hits 

v. "corn steep liquor" and "toxic?"- 70 hits, no relevant information 

b. ToxCenter- 3 records retrieved. No relevant information. 

c. Registry- Registry entry for corn steep liquor provides no useful property data. 

2. PUBMED 

a. "corn steep liquor"- 171 hits. 13 useful articles mostly pertaining to studies of 

feeding corn steep liquor to lactating cows, or use of CSL to biodegrade TNT, or 

as a medium to grow antibiotics. 

b. "condensed fermented corn extractives"- 0 hits. 

3. FDA GRAS- FDA GRAS Notice GRN 000065- Com steep liquor used as a 

fermentation medium to make nisin which is used in food. 

4. Toxnet- Includes CCRIS, DART, GENE-TOX, HSDB, IRIS, TOXLINE, LacMed. No 

relevant results. CSL is used as a medium for introducing chemicals into lab animals for 

oral toxicity studies. Results for "corn steep liquor" in Toxnet link to toxicity studies for 

other chemicals, not actual toxicity studies of corn steep liquor. Results for "condensed 

fermented corn extractives" gives 2 hits for nutritional value and chemical component of 

condensed fermented corn extractives. 

5. Canadian Feed Act- Condensed fermented corn extractives is an approved feed additive 

in Canada. 

6. HPV- High Production Volume- No relevant information. 

7. NTP- National Toxicology Program- No relevant information. 

8. SIDS- Screening Information Data Set- A SIDS is available for corn steep liquor, 

however, it contains limited useful information. 

9. !ARC- International Agency for Research on Cancer- No relevant information. 

12 
Appendix B (cont.) 

I 0. MHL W- Chemical Toxicity Database (Japan)- No relevant information. 

11. SIRI MSDS- MSDSs available for corn steep liquor. 

12. SRC- Syracuse Research Corporation- Includes TSCATS, EFDB, Ozone 

Depletion/Global Warming, Kow, PhysProp, ISE Model- No relevant information. 

13. TRACE- BIBRA - No BIBRA document on corn steep liquor. 

14. CANCERLINE- No relevant information. 

15. NICNAS - National Industrial Chemicals Notification and Assessment Scheme 

(Australia)- No relevant information. 

16. US Agency for Toxic Substances and Disease Registry- No relevant information. 

17. ECETOC JACC- Reports and inventories of critical reviews- No relevant information. 

18. ECB - European Chemicals Bureau -No relevant information. 

19. IPCS- Includes CICAD, EHC, HSG, ICSC, IPCS/CEC, JECFA, JMPR, PD, PIM, SIDS 

-No relevant information. 

20. The Carcinogenic Potency Project- No relevant information. 

21. Ecotox- No relevant information. 

22. ChemFinder- No entry for corn steep liquor. 

23. NCEA- US National Center for Environmental Assessment- No relevant information 

24. RIVM- Netherlands- No relevant information 

25. FERA- Fate, Exposure and Risk Analysis- No relevant information 

26. EF AST- No relevant information 

27. Merck Index- Entry for corn steep liquor obtained. 

28. Modeling - Modeling (ChemSTEER, EPISUITE) cannot be done on CSL because it is 

not a discreet chemical substance. 

13 
Appendix B: 2006 IUCLID Data Set 

14 
Existing Chemical 

Producer Related Part 

Company: 

Creation date: 

Substance Related Part 

Company: 

Creation date: 

Printing date: 

Revision date: 

Date of last Update: 

Number of Pages: 

Chapter (profile) : 

Reliability (profile) : 

Flags (profile) : 

201-164698 

RECEIVED 

OPPT CBIC 

2006 DEC 2 2 AM 9= 36 

I U C· L I D 

D a t a 

Substance ID: Corn Steep Liquor 

Keller and Heckman LLP 

28-NOV-2006 

Keller and Heckman LLP 

28-NOV-2006 

28-NOV-2006 

28-NOV-2006 

15 

Chapter: 1, 2, 3, 4, 5, 7 

s 

Reliability : without reliability, 1, 2, 3, 4 

e t 

Flags: without flag, confidential, non confidential, WGK 

(DE), TA-Luft (DE) 1 Material Safety Dataset, Risk 

Assessment, Directive 67/548/EEC 

- 1 -
1. General Information 

date: 28-NOV-2006 

Substance ID: Corn Steep Liquor 

1.0.1 OECD and Company Information 

Name: 

Remark : 

The Corn Refiners Association (CRA) 

The member companies are: 

Archer Daniels Midland Company 

Cargill, Inc. 

Corn Products International, Inc. 

National Starch and Chemical Company 

Penford Products Company 

Roquette America, Inc. 

Tate & Lyle Ingredients Americas, Inc. 

1.0.2 Location ofProduction Site 

Remark: Not an HPV Challenge endpoint. 

1.0.3 Identity of Recipients 

Remark: Not an HPV Challenge endpoint . 

1.1 General Substance Information 

Substance type: 

Physical status: 

Test substance: 

1.1.1 Spectra 

Remark : 

1.2 Synonyms 

1.3 Impurities 

Remark: 

1.4 Additives 

Remark: 

1.5 Quantity 

Quantity 

organic 

liquid 

Corn Steep Liquor (CAS~66071-94-l) 

Not an HPV Challenge endpoint. 

Corn steepwater 

Light steepwater 

Heavy steepwater 

Condensed fermented corn extractives 

None identified 

None identified 

>500,000 tons. The vast majority of production is for 

Non-TSCA regulated uses . 

- 2 -
1. General Information 

date: 28-NOV-2006 

Substance ID: Corn Steep Liquor 

1.6.1 Labelling 

Remark: 

1.6.2 Classification 

Remark: 

1.7 Use Pattern 

Remark : 

No specific labeling required. 

No specific classification. 

The primary use of corn steep liquor is as a nutrient additive 

in the feed for ruminant animals in which it provides a natural 

source of proteins, amino acids, vitamins, reducing sugars (e.g. , 

dextrose), organic acids (e.g., lactic acid), minerals, and 

other elemental nutrients. Some corn steep liquor is used in 

the production of acetic acids, food acids, and fermentation 

processes. Some corn steep liquor has been used in the 

pharmaceutical industry in the production of intravenous 

solutions and drugs, most notably antibiotics (penicillin). 

1.7.1 Technology Production/Use 

Remark: Not an HPV Challenge endpoint. 

1.8 Occupational Exposure Limit Values 

Remark: No TLV has been established 

1.9 Source of Exposure 

Remark: See discussion in accompanying corn steep liquor assessment 

plan. 

1.10.1 Recommendations/Precautionary Measures 

Remark: See corn steep liquor assessment plan. 

1.10.2 Emergency Measures 

Remark: See corn steep liquor assessment plan. 

1.11 Packaging 

Remark: Bulk, small and large packaging 

- 3 -
1. General Information 

1.12 Possib. of Rendering Subst. Harmless 

Remark: Not applicable 

1.13 Statements Concerning Waste 

date: 28-NOV-2006 

Substance ID: Corn Steep Liquor 

Remark: See corn steep liquor assessment plan . 

1.14.1 Water Pollution 

Remark: No t a s i gnificant source of water pollution. 

1.14.2 Major Accident Hazards 

Remark: None 

1.14.3 Air Pollution 

Remark: Not a significant source of air pollution. 

1.15 Additional Remarks 

Remark: None 

1.16 Last Literature Search 

Date of Search: 31 - 0CT- 2006 

1.17 Reviews 

Remark: None 

1.18 Listings e.g. Chemical Inventories 

Remark: TSCA inventory (USA) 

Domestic Substances List (DSL) - Canada 

EINECS (Europe) 

- 4 -
2. Physico-chemical Data 

date: 28-NOV-2006 

Substance ID: Corn Steep Liquor 

2.1 Melting Point 

Remark: 

2.2 Boiling Point 

(a) 

Value: 

GLP: 

Remark : 

Test substance : 

Source: 

Reliability: 

2.3 Density 

Value: 

GLP: 

Remark: 

Test substan.ce: 

Source: 

Reliability: 

2.3.1 Granulometry 

Remark: 

2.4 Vapor Pressure 

Value: 

GLP: 

Remark: 

Test substance : 

Source: 

Reliability : 

Not applicable. Corn steep liquor is a liquid . 

100-104°C 

Not reported 

Range reported in Material Safety Data Sheets. All values 

were similar across companies. 

Corn steep liquor (66071-94-1) 

Material Safety Data Sheets from from all six member 

companies. 

(4) Not assignable. As reported in MSDS. Original study 

reports not available. 

1. 2-1.4 g/cm3 

Not reported 

Range reported in Material Safety Data Sheets. 

Corn steep liquor (66071-94-1) 

Material Safety Data Sheets from from two member 

companies. 

(4) Not assignable. As reported in MSDS. Original study 

report not available. 

Not an HPV Challenge endpoint. 

17.5 mm Hg at 20°C 

Not reported 

Range reported in Material Safety Data Sheets. 

Corn steep liquor (66071-94-1) 

Material Safety Data Sheets from from three member 

companies. 

(4) Not assignable. As reported in MSDS. Original study 

report not available. 

2.5 Partition Coefficient 

Remark: No data available 

- 5 -
2. Physico-chemical Data 

2.6.1 Water Solubility 

Value: Soluble 

GLP: Not reported 

date: 28-NOV-2006 

Substance ID: Corn Steep Liquor 

Remark: 

Test substance: 

Reported in Material Safety Data Sheets. 

Corn steep liquor (66071-94-1) 

Source: 

Reliability: 

Material Safety Data Sheets from from five member 

companies. 

(4) Not assignable. As reported in MSDS. Original study 

report not available. 

2.6.2 Surface Tension 

Remark: Not an HPV Challenge endpoint. 

2. 7 Flash Point 

Remark: Not flammable . 

2.8 Auto Flammability 

Value: 

Remark : Not flammable. 

2.9 Flammability 

Result: 

Remark: Not flammable . 

2.10 Explosive Properties 

Result: 

Remark: Not explosive. 

2.11 Oxidizing Properties 

Result: 

Remark: Not an oxidizer. 

2.12 Additional Remarks 

Memo: None 

- 6 -
3. Environmental Fate and Pathways 

date: 28-NOV-2006 

Substance ID: Corn Steep Liquor 

3.1.1 Photodegradation 

Remark: Photodegradation is not expected to be a significant 

source of degradation. 

3.1.2 Stability in Water 

Remark: Corn steep liquor is approximately 50% water with the 

rest made up of water soluble proteins, free amino acids, 

minerals, vitamins, reducing sugars (such as dextrose), and 

other natural organic acids (such as lactic acid) . 

3.1.3 Stability in Soil 

Remark: Not an HPV Challenge endpoint. 

3.2 Monitoring Data (Environment) 

Remark: No data available 

3.3.1 Transport between Environmental Compartments 

Remark: 

3.3.2 Distribution 

Remark: 

Not an HPV Challenge endpoint. 

Corn steep liquor consists of natural water soluble materials, 

and, therefore, will be largely found in the water. 

3.4 Mode of Degradation in Actual Use 

Memo: 

3.5 Biodegradation 

Remarks: 

Corn steep liquor is readily degraded by biological means. 

Corn steep liquor is made up of natural constituents such as 

proteins, reducing sugars, and organic acids, and therefore, is 

readily degraded by biological means. 

- 7 -
3. Environmental Fate and Pathways 

date: 28-NOV-2006 

Substance ID: Corn Steep Liquor 

3.6 BODS, COD or BODS/COD Ratio 

Remarks: 

3.7 Bioaccumulation 

Remark: 

No data avialable 

Corn steep liquor is made up of water soluble components from 

soaking corn in water and is, therefore, not expected to 

bioaccumulate. 

3.8 Additional Remarks 

Memo: None 

- 8 -
4. Ecotoxicity 

date: 28-NOV-2006 

Substance ID: Corn Steep Liquor 

AQUATIC ORGANISMS 

4.1 Acute/Prolonged Toxicity to Fish 

Remark: Corn steep liquor is not expected to exhibit toxicity to 

fish or other aquatic organisms. Corn steep liquor consists 

of the water soluble components of corn that has been soaked 

in water. These all-natural constituents are primarily crude 

proteins, amino acids, vitamins, reducing sugars, organic acids 

(e.g., lactic acid), and other trace elemental nutrients. The 

primary use of corn steep liquor is as a nutrient source 

additive in animal feeds, and has a long history of safe use .• 

It should be noted that the available data for one component 

(lactic acid, which may make up 10-25% of the corn steep liquor) 

have been summarized for the HPV Challenge program. These data 

indicate very low aquatic toxicity for this component. 

4.2 Acute Toxicity to Aquatic Invertebrates 

Remark: As noted in the fish section above, corn steep liquor consists 

of all-natural, water soluble constituents of corn that has 

been soaked in water. No toxicity to aquatic invertebrates is 

expected. 

4.3 Toxicity to Aquatic Plants e.g. Algae 

Remarks: As above, no toxicity to aquatic plants is expected. Because 

corn steep liquor is a nutrient source, some enhancement of 

algal growth is possible if corn steep liquor reaches water 

bodies in concentrated form. However, this is unlikely since 

manufacture of corn steep liquor is controlled and its primary 

use as an additive in animal feed would result in only very 

dilute material potentially reaching water bodies. 

4.4 Toxicity to Microorganisms e.g. Bacteria 

Remarks: Corn steep liquor is used in the production of acetic acid, 

other food acids, and in fermentation processes. Therefore, 

the material would not inhibit microorganism growth, and in 

fact, would act as a nutrient source. 

4.5 Chronic Toxicity to Aquatic Organisms 

4.5.1 Chronic Toxicity to Fish 

Remark: Corn steep liquor is a nutrient source and is not expected 

to have any adverse chronic effects on fish. 

4.5.2 Chronic Toxicity to Aquatic Invertebrates 

Remark: Corn steep liquor is a nutrient source and is not expected 

to have any adverse chronic effects on aquatic invertebrates. 

- 9 -
4. Ecotoxicity 

TERRESTRIAL ORGANISMS 

4.6.1 Toxicity to Soil Dwelling Organisms 

date : 28-NOV-2006 

Substance ID : Corn Steep Liquor 

Remark: As with the aquatic systems, corn steep liquor is primarily 

used as a nutrient source in animal feed and, therefore, would 

not be expected to elicit any adverse effects on terrestrial 

organisms. 

4.6.2 Toxicity to Terrestrial Plants 

Remark: Not an HPV Challenge endpoint . 

4.6.3 Toxicity to other Non-Mamm. Terrestrial Species 

Remark: Not an HPV Challenge endpoint. 

4. 7 Biological Effects Monitoring 

Memo: Not an HPV Challe n ge e ndpoint . 

4.8 Biotransformation and Kinetics 

Remark: Not an HPV Ch allen ge e ndpoint . 

4.9 Additional Remarks 

Memo: None 

- 10 -
5. Toxicity 

5.1 Acute Toxicity 

date: 28-NOV-2006 

Substance ID: Corn Steep Liquor 

5.1.1 Acute Oral Toxicity 

Remarks : The safety of corn steep liquor to animals has been well 

established in numerous studies evaluating its use as a 

natural protein and nutrient source in animal feed. See 

Section 5.10 of this robust summary document for a summary 

of the safety of corn steep liquor. 

5.1.2 Acute Inhalation Toxicity 

Remark: Specific data on inhalation toxicity are not available. Since 

corn steep liquor is a viscous liquid used as a supplement in 

animal feeds and as a nutrient source in fermentation reactions, 

no inhalation exposure is expected. 

5.1.3 Acute Dermal Toxicity 

Remark: Specific data on dermal toxicity are not available. Since 

corn steep liquor is a viscous liquid used as a supplement in 

animal feeds and as a nutrient source in fermentation reactions, 

no dermal exposure is expected. 

5.1.4 Acute Toxicity, other Routes 

Remark: Not a required HPV endpoint. 

5.2 Corrosiveness and Irritation 

5.2.1 Skin Irritation 

Remark: Specific skin irritation data are not available. 

5.2.2 Eye Irritation 

Remark: Specific eye irritation data are not available . 

5.3 Sensitization 

Remark: No specific animal studies are available . 

- 11 -
5. Toxicity 

date: 28-NOV-2006 

Substance ID : Corn Steep Liquor 

5.4 Repeated Dose Toxicity 

Remark : The majority of safety studies conducted with corn steep liquor 

for its use in animal feed have been repeated dose feeding 

studies. No adverse effects were observed. See Section 5.10 

for a summary of the safety of corn steep liquor. 

5.5 Genetic Toxicity 'in Vitro' 

Remark: Specific in vitro genetic toxicity data are not available. 

5.6 Genetic Toxicity 'in Vivo' 

Remark: Not required . 

5.7 Carcinogenicity 

Remark: Not an HPV endpoint. 

5.8 Toxicity to Reproduction 

Remarks: Specific studies addressing the reproductive toxicity endpoint 

were not available, however, feeding studies on several animal 

species indicate that corn steep liquor does not present a 

reproductive toxicity concern. 

5.9 Developmental Toxicity/Teratogenicity 

Remark : Specific studies addressing the developmental toxicity endpoint 

were not available, however, feeding studies on several animal 

species indicate that corn steep liquor does not present a 

developmental toxicity concern. 

5.10 Other Relevant Information 

Remark : The safety and efficacy of corn steep liquor has been well 

established in numerous tests and has a long history of safe 

use as a nutrient in animal feed. Beginning in the 1880s, 

corn steep liquor has had steadily increasing production for 

animal feeds as ranchers have valued its safety and efficacy . 

Beef cattle and sheep 

Corn steep liquor is a staple item in ruminant feeding both as 

an ingredient in corn gluten feed and directly as a liquid 

feed supplement. Extensive feeding studies have demonstrated 

the safe use of this natural source of protein and other 

nutrients and vitamins. 

Poultry feed 

Corn steep liquor has long been used in the poultry industry 

for all types of birds (chicks, broilers, layers, and turkeys). 

A survey of the published data and reviews of unpublished chick 

- 12 -
5. Toxicity 

Source: 

Reliability: 

date: 28-NOV-2006 

Substance ID : Corn Steep Liquor 

feeding test data showed that even low levels of corn steep 

liquor stimulated the growth of young chickens. 

Dairy feeding 

Corn gluten feed containing corn steep liquor has been used 

in dairy rations for over 75 years. It provides a nutritional 

source that naturally enhances milk production. 

Swine rations 

Corn gluten feed containing 20-30% corn steep liquor or more 

has been used for many years for growing and finishing pigs. 

Gluten feed is usually palletized with other ingredients and 

supplemented with amino acids from corn steep liquor for feeding. 

Pet foods 

Corn gluten feed containing corn steep liquor has been included 

in some pet food formulations because it provides the required 

nutrients without the excessive calories of other feeds (corn 

steep liquor has virtually no fat) . 

Catfish feeding 

Feeding trials showed that corn gluten feed containing 20-30% 

corn steep liquor in the diet can be used to provide nutrients 

in catfish farms without reduction of growth rate or feed 

efficiency. 

Honey Bees 

Corn steep liquor (1%) has been shown to significantly increase 

the life span of honey bees, which acts as a source of proteins, 

amino acids, vitamins and minerals. 

In summary, corn steep liquor has been safely used for over a 

hundred years as a natural source of nutrients in animal feeds. 

No adverse toxicity has been observed in any of these studies. 

Pressick, J.C. 1985. To Prepare a Review on Corn Steepwater in 

Animal Feeding Showing its Long, Successful Feeding History, 

Safety and Efficacy. Internal report to the Corn Products 

Unit, Report No. 11337-7118,, July-August 1985, pp. 1-26. 

(4) Not assignable. Information as summarized in Pressick 1985. 

Original studies not available for review. 

5.11 Experience with Human Exposure 

Memo: Corn steep liquor has been used as a supplement in animal feed 

for many years without reported human incident. Corn steep 

liquor consists only of all-natural water soluble constituents 

of corn soaked in water, along with a very small amount of 

sulfurous acid (<0.01%), so no adverse effects to humans would 

be expected. 

- 13 -
6. References 

date; 28-NOV-2006 

Substance ID: Corn Steep Liquor 

ADM. 2002. Material Safety Data Sheet: Corn Steepwater. Archer Daniels Midland 

Company, Decatur, IL. August 2002. 

Budavari, S. (ed.). 1996. Merck Index (12th edition), Merck Research 

Laboratories, Whitehouse Station, NJ. 

Butzen, S., and Hobbs, T. 2002. Corn processing III: wet milling. Crop 

Insights, 12(15): 1-6. 

Cargill Corn Milling. 1997. Material Information Sheet: Steepwater. Cargill 

Corn Milling, Blair, NE. 

Corn Products U.S. 2004. Material Safety Data Sheet: Corn Steepwater. Corn 

Products U.S., Westchester, IL. 

CRA. 2002. The Process (Step-by-step): Steeping. Corn Refiners Association. 

Available at http://www.corn.org/web/steep.htm. 

CRA. 2006a. Corn Wet Milled Feed Products (4th edition), Corn Refiners Association, 

Washington, DC. 

CRA. 2006b. Tapping the Treasure. Corn Refiners Association. Available at 

http://www.corn.org/Tapping2006.pdf. 

CRA. 2006c. Shipment of Products of the Corn Refining Industry - 2005. Corn 

Refiners Association. Available at http://www.corn.org/web/shipprod.htm. 

FDA. 2002. Food Additives - Alphabetical List. Food and Drug Administration. 

Available at http://www.foodstandards.gov.au/ srcfiles/new alpha list 0902.pdf. 

IUCLID Data Set. CAS No. 66071-94-1. Corn Steep Liquor. February 2000. Year 2000 

CD-ROM Edition. 

Liggett, W.R., and Koffler, H. Corn Steep Liquor in Microbiology. Bacterial. 

Rev., 12 (4): 297-311. 

Linton, J.H., and Hussar, N. 1989. Animal Feed Supplement Prepared from Wet 

Corn Bran and Corn Steep Liquor. United States Patent 4,859,485. Aug. 22, 1989. 

National Starch and Chemical. 2005. Material Safety Data Sheet: Heavy Steep 

Water. National Starch and Chemical Company, Bridgewater, NJ. 

Penford Products Co. 2005. Material Safety Data Sheet: Heavy Steepwater. 

Penford Products Co., Cedar Rapids, IA. 

Pressick, J.C. 1985. To Prepare a Review on Corn Steepwater in Animal Feeding 

Showing its Long, Successful Feeding History, Safety and Efficacy. Internal 

report to the Corn Products Unit, Report No. 11337-7118,, July-August 1985, 

pp. 1-26. 

Staley. 1991. Material Safety Data Sheet: Corn Steep Liquor. A. E. Staley 

Manufacturing Co, Decatur, IL. 

USDA. 2006. AES Timeline: The Rescue of Penicillin. United States Department 

of Agriculture. Available at http://www.ars.usda.gov/is/timeline/penicillin.htm. 

Westburg, J.A. 2006. Process for Manufactoring Animal Feed Supplements. 

United States Patent 7,045,165 B2. May 16, 2006. 

White, P. and Johnson, L.A., (eds.). 2003. Corn: Chemistry and Technology 

(2nd Edition), American Association of Cereal Chemists. 

- 14 -
7. Risk Assessment 

date: 28-NOV-2006 

Substance ID: Corn Steep Liquor 

7.1 Risk Assessment 

Memo: See the assessment plan for corn steep liquor. Based on the 

fact that corn steep liquor consists only of all-natural 

nutrients resulting from soaking corn in water, along with a 

very small amount of sulfurous acid (<0.01%), no adverse 

effects would be expected. 

- 15 -
Corn Steep Liquor 

Crop Production 

I 

2 Identification of Petitioned Substance 

3 Chemical Name: 

Corn Steep Liquor 

Other Names: 17 

CAS Number: 

66071-94-1 

Other Codes: 

4 

5 

6 

7 

8 

9 

(Corn steepwater, light steepwater, heavy 

steepwater, condensed fermented corn 

extractives 

European Inventory of Existing Commercial 

Chemical Substances (EINECS) No. 266-113-4 

10 

11 

12 

13 

14 

15 

16 

23 

Trade Names: 

18 

19 

20 

21 

22 

24 Characterization of Petitioned Substance 

25 

26 

27 Composition of the Substance: 

28 

29 Steeping is a procedure used during wet corn milling. The major objectives for corn steeping are to induce 

30 chemical and physical changes in the kernel by leaching the soluble components from the corn. Cleaned 

31 shelled corn is soaked for 30-48 hours at 120- 130° Fin a dilute sulfur dioxide solution. The steeped liquid 

32 is then separated from the non-soluble corn solids, which are further separated into germ, bran, starch, and 

33 gluten protein. The steeped liquor is concentrated by evaporation into Condensed Corn Fermented 

34 Extractives or Corn Steep Liquor (CSL). Corn steep liquor is a mixture of soluble protein, amino acids, 

35 carbohydrates, organic acids (e.g., lactic acid), vitamins, and minerals. 

36 

37 Wet corn milling is used to produce numerous corn based products that are subsequently used as biofuel, 

38 ingredients in food, and for livestock feed. These products include starch, high fructose corn syrup, oil, 

39 ethanol, bran, gluten feed, and meal. Corn steep liquor is one of the byproducts of corn wet milling 

40 directed to the production of animal feed. It is also used as a nutrient for microorganisms in the 

41 production of enzymes, antibiotics, and other fermentation products. 

42 

43 Properties of the Substance: 

44 

Product Chemistry 

Physical State Liquid 

Melting Point 

Boiling Point 

Density 

Not applicable, corn steep liquor is a liquid 

100 -104 degrees Centigrade 

Vapor Pressure 

Flammability/flame Extension 

Explodability 

Solubility 

February 1, 2010 

1.2 to 1.4 g/cm3 

17.5 mm, 20 degrees Centigrade 

not flammable 

not explosive 

Soluble in water 

Technical Evaluation Report 

Compiled by the Technical SeNices Branch for the USDA National Organic Program 

Page 1 ofB 
45 

46 

47 

48 

4 

Technical Evaluation Report 

I Oxidizer 

50 Specific Uses of the Substance: 

51 

Corn Steep Liquor Crop Production 

not an oxidizer 

52 CSL is a mixture of soluble proteins, amino acids, carbohydrates, organic acids (e.g., lactic acid), vitamins, 

53 and minerals. It is used as a nutrient for microorganisms in the production of enzymes, antibiotics, and 

54 other fermentation products. It is sometimes combined with other ingredients in corn gluten feed and 

55 widely used in complete feeds for dairy and beef cattle, poultry, swine, and pet foods. It may also be sold 

56 separately as a liquid protein source for beef or dairy rations. 

57 

58 Approved Legal Uses of the Substance: 

59 

60 The Association of American Feed Control Officials, Inc. (AAFCO) has listed corn step liquor as a livestock 

61 feed ingredient. 

62 

63 The following is quoted directly from the AAFCO homepage. 

64 

65 "The purpose of the corporation shall be to establish and maintain an Association through which officials 

66 of any state, dominion, federal or other governmental agency and employees thereof charged with a 

67 responsibility in enforcing the laws regulating the production, labeling, distribution, or sale of animal feeds 

68 or livestock remedies may unite to explore the problems encountered in administering such laws, to 

69 develop just and equitable standards, definitions and policies to be followed in enforcing such laws, to 

70 promote uniformity in such laws, regulations and enforcement policies, and to cooperate with members of 

7 1 the industry producing such products in order to promote the effectiveness and usefulness of such 

72 products." 

73 

74 Action of the Substance: 

75 

76 Corn steep liquor is a byproduct of wet com milling. Its components are soluble proteins, amino acids, 

77 carbohydrates, organic acids (e.g., lactic acid), vitamins, and minerals. It is sometimes combined with 

78 other ingredients in corn gluten feed and widely used in complete feeds for dairy and beef cattle, poultry, 

79 swine, and pet foods. Some com steep liquor is used in the production of acetic acid, food acids, and 

80 fermentation processes. Some com steep liquor is used in the pharmaceutical industry in the production of 

81 intravenous solutions and drugs, most notably antibiotics (penicillin). 

82 

83 

84 Status 

85 

86 U.S. Environmental Protection Agency 

87 

88 Corn steep liquor is one of 2800 High Production Volume (HPV) chemicals identified on the US 

89 Environmental Protection Agency's (USEPA) 1990 Toxic Substances Control Act (TSCA) Inventory Update 

90 Rule (IUR). HPV chemicals are those that are manufactured or imported in quantities greater than 1 

91 million pounds per year. 

92 

93 The following information is quoted directly from the USEP A homepage for New Chemicals. 

94 

95 "Under the Toxic Substances Control Act, section 8(b) provides EPA authority to "compile, keep current, 

96 and publish a list of each chemical substance that is manufactured or processed in the United States." TSCA 

97 section 3(2)(A) states that "the term 'chemical substance' means any organic or inorganic substance of a 

February 1, 2010 Page 2 ofB 
Technical Evaluation Report Corn Steep Liquor Crop Production 

98 particular molecular identity, including - (i) any combination of such substances occurring in whole or in 

99 part as a result of a chemical reaction or occurring in nature, and (ii) any element or uncombined radical." 

100 TSCA does not include chemical substances subject to other US statutes such as foods and food additives, 

101 pesticides, drugs, cosmetics, tobacco, nuclear material, or munitions." 

102 

103 U.S. Food and Drug Administration 

104 

105 Corn steep liquor is not listed as Generally Recognized as Safe by the FDA (FDA, 2004), but is listed as a 

106 component of a color additive allowed in chicken feed. 

107 

108 The following is directly quoted from 21 CFR Sec. 73.275. 

109 

110 "§ 73.275 Dried algae meal. 

111 (a) Identity. The color additive dried algae meal is a dried mixture of algae cells (genus Spongiococcum, 

112 separated from its culture broth), molasses, cornsteep liquor, and a maximum of 0.3 percent ethoxyquin. 

113 The algae cells are produced by suitable fermentation, under controlled conditions, from a pure culture of 

114 the genus Spongiococcum. 

115 (b) Uses and restrictions. The color additive dried algae meal may be safely used in chicken feed in 

116 accordance with the following prescribed conditions: (1) The color additive is used to enhance 

117 the yellow color of chicken skin and eggs. (2) The quantity of the color additive incorporated in the feed is 

118 such that the finished feed: (i) Is supplemented sufficiently with xanthophyll and associated carotenoids 

119 so as to accomplish the intended effect described in paragraph (b)(1) of this section; and (ii) Meets the 

120 tolerance limitation for ethoxyquin in animal feed prescribed in§ 573.380 of this chapter." 

121 

122 Association of American Feed Control Officials, Inc. 

123 

124 The Association of American Feed Control Officials, Inc has listed corn steep liquor as a livestock feed ingredient. 

125 

126 International: 

127 

128 The European Union permits the use of stillage and stillage extracts as fertilizers and soil conditioners in 

129 organic crop production, however, corn steep liquor is not mentioned specifically (European Union, 2008). 

130 Stillage is defined as the mash from the fermentation of grains after the removal of alcohol by distillation 

131 (Association of American Feed Control Officials, 2005). Maize bran and gluten from wet corn milling are 

132 permitted as feed materials used in livestock production (European Union, 2008). European manufacturers 

133 refer to corn wet milling as maize processing. The processes are the same, which includes the use of sulfur 

134 dioxide. 

135 

136 The Codex Alimentarius permits the use of stillage and stillage extracts as fertilizers and soil conditioners 

137 in organic crop production, however, corn steep liquor is not mentioned specifically (Codex Alimentarius, 

138 2008). 

139 

140 Corn steep liquor is included on the chemical inventory of the Domestic Substances List by the Canadian 

141 government. 

142 

143 Evaluation Questions for Substances to be used in Organic Crop or Livestock Production 

144 

145 Evaluation Question #1: Is the petitioned substance formulated or manufactured by a chemical process? 

146 (From 7 U.S.C. § 6502 (21).) 

147 

148 Corn steep liquor is produced by steeping corn grain in water for up to 48 hours. The soluble components 

149 in the corn are removed because a natural lactic fermentation is taking place during steeping. Sulfur 

150 dioxide is added at rates of 0.1 to 0.2 percent and is used to cleave disulfide linkages, resulting in the 

151 degradation of the corn protein that encapsulates the starch granules. The starch is then released from the 

152 encapsulating material. The steep water containing the corn solubles are concentrated with evaporators to 

February 1, 2010 Page 3 ofB 
Technical Evaluation Report Corn Steep Liquor Crop Production 

153 form corn steep liquor. Corn steep liquor is a mixture of soluble protein, amino acids, carbohydrates, 

154 organic acids (e.g., lactic acid), vitamins, and minerals. The nitrogen fraction is high in free amino acids 

155 and small peptides. In four samples of corn steep water, Hull et al., (1996) found a number of small poly156 peptides present. Concentrations of poly-peptides generally increased during steeping. In the same study, 

157 Hull et al., (1996) found the amino acids glutamine, leucine, proline, and asparagine at the highest 

158 concentrations. Lower concentrations of lysine, cysteine, and methionine were reported. Concentrations of 

159 amino acids generally increased during steeping. The composition of amino acids in the four corn steep 

160 liquor samples compared characteristically similar to corn albumin, globulin, glutelin, and zein proteins 

161 (Wilson, 1987). Hull et al., (1996) found various non-protein nitrogenous compounds in corn steep water. 

162 Enzymatic activities provided no evidence for proteases during steeping, however, the length of steeping 

163 time (up to 30 hours), coupled with the higher temperature (50 to 55 degrees Centigrade) and the presence 

164 of micro-organisms could contribute to the enhancement of proteolytic activity during steeping (Hull et al., 

165 1996). Corn steep liquor is very high in phosphorus, potassium, and sulfur (Kalscheur, et al., 2008). 

166 

167 Therefore, the chemical composition of corn steep liquor will probably vary and is reflective of the 

168 processing strategy used by a particular manufacturer, depending on which corn component they are 

169 interested in isolating. Factors affecting the composition of CSL are corn hybrid, steeping time, 

170 temperature, and the presence of micro-organisms. 

171 

172 Evaluation Question #2: Is the petitioned substance formulated or manufactured by a process that 

173 chemically changes the substance extracted from naturally occurring plant, animal, or mineral sources? 

174 (From 7 U.S.C. § 6502 (21).) 

175 

176 Corn steep liquor is derived from corn which is a naturally occurring plant. Clean corn is steeped in warm 

177 water containing small amounts of sulfur dioxide. Soaking softens the kernels and the dilute sulfurous 

178 acid formed when the sulfur dioxide reacts with water prevents excessive bacterial growth and loosens the 

179 gluten bonds within the corn and releases the starch. The steep water absorbs the soluble components and 

180 is later evaporated and concentrated to a solid content of about 50%. As mentioned in the response to 

181 Question 1, the chemical composition of corn steep liquor will probably vary and is reflective of the 

182 processing strategy used by a particular manufacturer, depending on which corn component they are 

183 interested in isolating. This is affected by steeping time, temperature reached during the lactic acid 

184 fermentation, and the microbial environment of the fermentation (Hull et al., 1996). These factors will also 

185 likely affect the quality of the fermentation end-products. 

186 

187 Evaluation Question #3: Is the petitioned substance created by naturally occurring biological 

188 processes? (From 7 U.S.C. § 6502 (21).) 

189 

190 Corn steep liquor is not created by a naturally occurring biological process. It is created as a result of a 

191 process designed to separate corn into its four basic components, starch, germ, fiber, and protein in an 

192 aqueous medium. It is a complicated process of chemical and biochemical reactions that, despite the long 

193 history of the wet-milling industry, are still not fully understood. A summary of the process is provided in 

194 evaluation question #1. 

195 

196 Evaluation Question #4: Is there environmental contamination during the petitioned substance's 

197 manufacture, use, misuse, or disposal? (From 7 U.S.C. § 6518 (m) (3).) 

198 

199 

200 

Manufacture 

201 Corn steep liquor, itself, should not cause any environmental contamination, because the material is 

202 approximately 50% water and the soluble proteins, amino acids, carbohydrates, organic acids (e.g., lactic 

203 acid), vitamins, and minerals would be readily metabolized and utilized by micro-organisms. The sulfur 

204 dioxide added to the fermented material to cleave the disulfide linkages may need to be vented to the 

205 atmosphere. However, the wet corn milling process that generates corn steep liquor may have some issues 

February 1, 2010 Page 4 of 8 
Technical Evaluation Report Corn Steep Liquor Crop Production 

206 of concern related to environmental contamination. The wet milling process is designed to separate the 

207 corn into its components, starch, germ, protein (gluten) and fiber and convert them into higher value 

208 products such as starch, high fructose corn syrup, corn oil, ethanol, bran, gluten feed, and meal. It is the 

209 making of the high value products that result in the generation of millions of pounds of waste at wet corn 

210 milling plants annually. If the waste is not managed properly it will stress the environment. The US EPA 

211 has funded a pilot project to assist small and medium-size manufacturers who want to minimize their 

212 generation of waste but who lack the expertise to do so. For more information see: 

213 http://www.p2pays.org/ref/02/01481.pdf. 

214 

215 Corn dust produced during the handling and cleaning processes could be a safety hazard, due to the fact 

216 that the corn dust is explosive. The organic materials used to extract the corn oil from the germ may be a 

217 concern, due to accidental spills and the release of volatile organic compounds. There are no reported 

218 incidences on environmental contamination due to the production of corn steep liquor. 

219 

220 Evaluation Question #5: Is the petitioned substance harmful to the environment? (From 7 U.S.C. § 6517 

221 (c) (1) (A) (i) and 7 U.S.C. § 6517 (c) (2) (A) (i).) 

222 

223 Corn steep liquor, itself, should not cause any environmental contamination, because the material is 

224 approximately 50% water and the soluble proteins, amino acids, carbohydrates, organic acids (e.g., lactic 

225 acid), vitamins, and minerals would be readily metabolized and utilized by micro-organisms. Corn steep 

226 liquor could be used in crop production to add organic matter and other nutrients to the soil, however, 

227 there are probably other materials (animal manures) that are more cost effective. Corn steep liquor is used 

228 in the diets of ruminants (Kalscheur eta!., 2008). 

229 

230 Evaluation Question #6: Is there potential for the petitioned substance to cause chemical interaction 

231 with other substances used in organic crop or livestock production? (From 7 U.S.C. § 6518 (m) (1).) 

232 

233 The water, soluble proteins, amino acids, carbohydrates, organic acids (e.g., lactic acid), vitamins, and 

234 minerals in corn steep liquor would be readily metabolized and utilized by microorganisms. Corn steep 

235 liquor should not interact chemically with other substances used in organic crop or livestock production. 

236 

237 Evaluation Question #7: Are there adverse biological or chemical interactions in the agro-ecosystem by 

238 using the petitioned substance? (From 7 U.S.C. § 6518 (m) (5).) 

239 

240 Corn steep liquor should not cause any adverse biological or chemical interactions in the agro-ecosystem. 

241 The release of lactic acid, which comprises 10 to 25% of corn steep liquor, to the environment, may be an 

242 issue, if large quantities were released to the environment. However, this would not be expected since the 

243 production of corn steep liquor is performed by a controlled process. Any lactic acid released to the 

244 environment would be readily metabolized and utilized as an energy source by micro-organisms, 

245 therefore, it should have little to no long-term impact on the agro-ecosystem. 

246 

247 Evaluation Question #8: Are there detrimental physiological effects on soil, organisms, crops, or 

248 livestock by using the petitioned substance? (From 7 U.S.C. § 6518 (m) (5).) 

249 

250 There is no information available to indicate that using corn steep liquor has detrimental physiological 

251 effects on soil, organisms, crops, or livestock. Because it is rich in nutrients, it can be applied to soils as a 

252 fertilizer or soil conditioner and it has been successfully fed to livestock for many years (Kalscheur eta!., 

253 2008). 

254 

255 Evaluation Question #9: Is there a toxic or other adverse action of the petitioned substance or its 

256 breakdown products? (From 7 U.S.C. § 6518 (m) (2).) 

257 

258 Corn steep liquor should not have any toxic or other adverse actions. The components of corn steep liquor 

259 are readily metabolized and utilized by micro-organisms as an energy source. Because corn steep liquor is 

260 a nutrient source, algal growth is possible, if .corn steep liquor reaches bodies of water in concentrated 

February 1, 2010 Page 5 of 8 
Technical Evaluation Report Corn Steep Liquor Crop Production 

261 form. However, the manufacturing of corn steep liquor is a controlled process and given the current uses 

262 of corn steep liquor, one would not expect large quantities of corn steep liquor being released to bodies of 

263 water. 

264 

265 Hull eta!., (1996) analyzed four different corn steep waters for chemical composition. When analyzed for 

266 heavy metals, iron was the most prevalent heavy metal present in corn steep water. Chromium and 

267 cadmium were not detected in the four samples. Copper and nickel were detected at levels approximately 

268 5 to 10% of that of iron (1.6 mg/L or less). Lead was detected in one sample (36 ug/L). 

269 

270 Evaluation Question #10: Is there undesirable persistence or concentration of the petitioned substance 

271 or its breakdown products in the environment? (From 7 U.S.C. § 6518 (m) (2).) 

272 

273 The components of corn steep liquor are readily metabolized and utilized by micro-organisms as energy 

274 sources, therefore, corn steep liquor would not persist and concentrate in the natural environment. 

275 

276 Evaluation Question #11: Is there any harmful effect on human health by using the petitioned 

277 substance? (From 7 U.S.C. § 6517 (c) (1) (A) (i), 7 U.S.C. § 6517 (c) (2) (A) (i) and), 7 U.S.C. § 6518 (m) (4).) 

278 

279 Corn steep liquor has no harmful effects on human health. The components of corn steep liquor are used 

280 as ingredients in foods for human consumption (proteins, amino acids, carbohydrates, vitamins, and 

281 minerals). Corn steep liquor has been successfully fed to livestock for many years (Kalscheur eta!., 2008) 

282 without any adverse effects on human health. 

283 

284 Individuals who handle corn steep liquor should wear gloves, protective clothing, and protective eyeware. 

285 

286 Evaluation Question #12: Is there a wholly natural product that could be substituted for the petitioned 

287 substance? (From 7 U.S.C. § 6517 (c) (1) (A) (ii).) 

288 

289 In the case of adding organic matter to soils for crop production, composted and raw manures could be 

290 used depending on the crop being grown, time of harvest, and whether the crop will be used for human 

291 consumption (Organic Materials Review Institute, 2007). For adding inorganic nutrients to soils, 

292 unprocessed mined materials could be used ·(Organic Materials Review Institute, 2007). 

293 

294 In the case of supplementing livestock feeds with vitamins and minerals, natural vitamin supplements and 

295 non-synthetic minerals, respectively, can be used (Organic Materials Review Institute, 2007). 

296 

297 Wet corn milling is defined as corn steeped in water with or without sulfur dioxide to soften the kernel in 

298 order to facilitate the separation of the various component parts (Association of American Feed Control 

299 Officials, 2005). Therefore, the wet corn milling could be conducted without sulfur dioxide, the lactic acid 

300 fermentation and the subsequent separation of the corn components (including natural drying to 

301 concentrate the soluble materials in the liquid portion) may be another method of processing the corn. 

302 This may be an alternative to adding sulfur dioxide after the lactic acid fermentation and the concentrating 

303 of the corn steep liquor with evaporators. However, the quantities and quality of the end-products may be 

304 different. 

305 

306 In the case of organic crop production, corn steep liquor would be used in very few, if any, products on the 

307 National List of Allowed and Prohibited Substances. As in (7 CFR 206.601), herbicides (soap-based) for 

308 use in farm stead maintenance and ornamental crops would be a mixture of either calcium or sodium fatty 

309 acids and corn steep liquor should not be used in their manufacture. However, in the case of organic 

310 livestock production, trace mineral and vitamin supplements are allowed for enrichment or fortification 

311 when FDA approved. If feed ingredient manufacturers use corn steep liquor to produce trace mineral and 

312 vitamin supplements, this would be a significant use of corn steep liquor in organic livestock production. 

313 

314 Evaluation Question #13: Are there other already allowed substances that could be substituted for the 

315 petitioned substance? (From 7 U.S.C. § 6517 (m) (6).) 

February 1, 2010 Page 6 ofB 
Technical Evaluation Report Corn Steep Liquor Crop Production 

316 

317 As alternatives, organic crop producers could use synthetic substances that are already allowed in organic 

3 I 8 crop production to amend soils listed in 7 CFR 205.601. They include: 1) elemental sulfur; 2) magnesium 

3 I 9 sulfate; 3) soluble boron products; 4) sulfates, carbonates, oxides, or silicates of zinc, copper, iron, 

320 manganese, molybdenum, selenium, and cobalt; and 5) vitamins 81, C, and E. Depending on the crop of 

321 interest and the micro-nutrient that is in deficiency, some decision would have to be made about which one 

322 would be the most appropriate to use. 

323 

324 As alternatives, organic livestock producers could use synthetic substances that are already allowed in 

325 organic livestock production to maintain productive and healthy animals listed in 7 CFR 205.603. They 

326 include the following feed additives: 1) magnesium sulfate; 2) trace minerals (used for enrichment or 

327 fortification when approved by the FDA); and 3) vitamins (used for enrichment or fortification when 

328 approved by the FDA). Depending on the livestock species and the micro-nutrient or vitamin that is in 

329 deficiency, some decision would have to be made about which one would be the most appropriate to use. 

330 In both cases (crop production and livestock production), the conditions for using materials on the 

331 National List of Synthetic Substances must be documented in the organic farming system plan. 

332 

333 

334 Evaluation Question #14: Are there alternative practices that would make the use of the petitioned 

335 substance unnecessary? (From 7 U.S.C. § 6517 (m) (6).) 

336 

337 As found in 7 CFR 205.205, organic crop producers must implement a crop rotation including but not 

338 limited to sod, cover crops, green manure crops, and catch crops that provides for maintaining and 

339 improving soil organic matter content and managing deficient or excess plant nutrients. More specifically 

340 7 CFR 205.203 states that organic crop producers: 1) must select and implement tillage and cultivation 

341 practices that maintain or improve the physical, chemical, and biological condition of soil and minimize 

342 erosion; 2) must manage crop nutrients and soil fertility through rotations, cover crops, and the application 

343 of plant and animal materials; and 3) must manage plant and animal materials to maintain or improve soil 

344 organic matter content in a manner that does not contribute to contamination of crops, soil, or water by 

345 plant nutrients, pathogenic organisms, heavy metals, or residues of prohibited substances. When these 

346 practices prove insufficient to prevent deficient or excess nutrients in soils or plants, a substance on the 

347 National List of Synthetic Substances allowed for use in organic crop production (7 CFR 205.601) may be 

348 applied to maintain adequate nutrients for plant productivity and health (see the information in response 

349 to Question13) .. 

350 

351 As found in 7 CFR 205.237, organic livestock producers must provide livestock with a total feed ration 

352 composed of agricultural products, including pasture and forage, that are organically produced and if 

353 applicable, organically handled. Non-synthetic substances and synthetic substances allowed in 7 CFR 

354 205.603 may be used as feed additives and supplements (see the information in response to Question 13). 

355 

356 References 

357 

358 Association of American Feed Control Officials. 2005. Definition of terms. Page 28. 2005 Official 

359 Publication. Association of American Feed Control Officials. 

360 

361 Codex Alimentarius. 2008. Guideline 32: Guidelines for the Production, Processing, Labelling, and 

362 Marketing of Organically Produced Foods. 

363 

364 European Union. 2008. See: 

3 65 http:// eur-lex.eu ropa .eu I Lex UriServ /Lex UriS rv .do?uri=CONSLEG :1991 R2092:20071227: EN :PDF 

366 

367 Hull, S.R., B.Y. Yang, D. Venzke, K. Kulhavy, and R. Montgomery. 1996. Composition of corn steep water 

368 during steeping. J. Agric. Food Chern. 44:1857-1863. 

369 

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T echnica/ Evaluation Report Corn Steep Liquor Crop Production 

370 Kalscheur, K, A. Garcia, K. Rosentrater, and C. Wright. 2008. Ethanol Co-products for Ruminant Livestock 

371 Diets. http://www.thedairysite.com August, 2008. · 

372 

373 Organic Materials Review Institute. 2007. Generic Materials List. See: http://www.omri.org 

374 

375 U.S. Food and Drug Administration. 2004. "Guidance for Industry: Frequently Asked Questions About 

376 GRAS," Center for Food Safety and Applied Nutrition (CFSAN), December 2004, Hypertext updated 

377 March 15,2006. Accessed at: http://www.cfsan.fda.gov/-dms/grasguid.html#Q1 

378 

379 Wilson, C.M. 1987. Proteins of the kernel. In Corn: Chemistry and Technology; Watson, S.A. and P.E. 

380 Ramsted, Eds.; Amer. Assoc. of Cereal Chemists; St. Paul, Minnesota; pages 273 - 310. 

381 

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