# KH**·** 

### KELLERAND 

## H :; MAN LLP Serving**Bu.~iness** throu gh LowandS ·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 ofPollution Prevention and Toxics U.S. Environmental Protection Agency 1200 Pennsylvania Ave., NW Washington, DC 20460-0001 Writer's DirectAccess Herbert Estreicher, J.D., Ph.D. (202) 434-4334 estrei cher@khIaw. com



### Re: REQUEST FOREXEMPTION OF CORN STEEPLIQUORFROM TSCA CHEMICAL DATA REPORTING (CDR) PROCESSING AND USE INFORMATION REPORTING REQUIREMENTS IN 2016 Dear Sir orMadam: The ComRefiners 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 DataReporting (CDR) processing and use reporting requirements (Part III ofthereporting 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 oflow risk to human health and the environment. 

### I BASIS FORPETITION EPAregulations at 40 C.F.R. § 711.15(b)(2)(iii) permit any person to requestthat the EPA amendthe list ofsubstances of"low current interest" that are partially exempt from CDR requirements, specifically from the processing and use reporting requirements contained in40 C.F.R. 

### § 711.15(b)(4). EPA states that in making the determination ofwhether 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 ofthe six exemption considerations for com steep liquor. Most importantly, our petition demonstrates that there is "low current interest" in CDRprocessing and use data for this product because it is oflow potential human and environmental risk, is comprehensively regulated by other state and federal agencies, inparticularthe U.S. Food and Drug Administration, has a long history ofsafe 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

### KELLERAND HECKMANLLP 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 ofCDRpartially exempt substances. 

### II TSCA REGULATED USES According to the CDRreports the TSCAregulated uses include corrosion inhibitors and anti-scaling agents. Even though the subjectrequest is to partially exempt com steep liquor for the 2016 CDR reporting cycle, the Coalition requests that the EPAprovide 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 similarrequests and is anxious to receive the Agency's feedback on its general approach as reflected inthe subjectpetitions

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 (Whetherthe chemical qualifies orhas qualified in pastIUR collections for the reporting ofthe 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 whetherthe substance meets the criteria of"whetherthe chemical qualifies orhas qualified in past IUR collections for the reporting ofinformation 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 peryear. Data reported to EPA for purposes ofiURon 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, Compiledby the Technical Services Branch for the USDA National OrganicProgram 

### which are provided as an appendix to this submission. The following provides a summary ofthe 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 Othernames: 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 ofsoluble 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 of7.5% oftotal composition on dry basis *Source: ComRefiners 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 AssessmentPlan, com steep liquoris a byproduct of the initial stages ofwet milling ofcom. Steeping ofcom (i.e., soaking in water) aids in the separation the various components ofcom such as starch and nutrients. Corn is normally steeped in stainless steel drums holding from 3,000-25,000 bushels ofcorn. Approximately 5-9 gallons ofwater per bushel ofcom is added to the tank. The water originates elsewhere in the wet millingprocess where it has already obtained some soluble com matter. The temperature ofthe water is maintained at 45- 54.C by heating the water as it is recirculated orby using a heat exchanger Immediately before adding the waterto drums, an aqueous source ofsulfur dioxide is added to the waterto a concentration of0.1- 0.2%. In water, these sources ofsulfur dioxide form sulfurous acid, which controls fermentation and softens the comkernel to aid in the separation ofthe cornproducts. Most ofthe sulfurous acid is absorbed by the corn kernels so that after ten hours the concentration ofsulfurous acid inthe steepwateris loweredto 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 withthe highest concentration ofthe sulfurous acid. The water is thenmoved to fresher com so that the oldest CSL is in contact withthe freshest corn. Approximately onethird ofthe 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 meettheir own specifications. d. 

### Uses According to the IUCLID data set, the primary use ofcorn steep liquor is as a nutrient additive in the feed for ruminant animals in which it provides a natural source ofproteins, 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 ofacetic acids, food acids, and fermentation processes. Some com steep liquor has been used in the pharmaceutical industry in the production ofintravenous solutions and drugs, most notably antibiotics (penicillin). A small amount ofcom 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 ofanimal 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 ofthese studies. 

### b. Ecological Toxicity and Environmental Fate 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 ofthe water soluble components ofcomthat 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 othertrace elemental nutrients. The primary use ofCSL is as a nutrient source additive in animal feeds, and has a long history ofsafe 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 ofthe CSL mixture. In addition, CSL is used in the production ofacetic 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 ofwater soluble nutrients, it would be expected that it would be present largely in the water compartment in the environment. The individual components ofthe mixture are natural nutrients, so would rapidly be assimilated as an energy source in normal cellular processes. 

### c. Exposure 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. The majority ofCSL 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 ofacetic acid, food acids, and in fermentation processes. CSL is also used by the pharmaceuticals industry in the production ofintravenous solutions and drugs, most notably antibiotics. Worker exposure to CSL during its manufacturing is limited by the automation ofthe steeping process. The water is piped into the steeping tanks and from one tank to another. While small amounts ofinhalation are possible during the evaporation ofwater from the CSL, the vapor would contain mostly water as the solid fraction ofthe CSL would remain in the evaporation tanks. The low amount ofsulfurous 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 ofthe CSL with com gluten to make animal feed, and during the packaging ofcom 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 orplaced in storage. Exposure might also be possible during the cleaning ofequipment used in the manufacturing process. Exposure during consumer use could occur when giving animals pre-mixed feeds or supplements containing CSL, or during pouring ofliquid feed supplements into feed mixers for subsequent distribution to animals. Exposure is not likely to cause adverse effects, since all components ofcom steep liquor are natural to the com except for the small amount ofsulfurous 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 inthe 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, Compiledby 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 ofEPA, other federal agencies, tribes, states, and local governments, as well as members ofthe public). 

### Com steep liquor has not been the subject oforconsidered 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 (ATSDR). Com steep liquor has not been or is it the subject ofany 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 NewUse 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 Subjectto Reporting Rules onProduction TSCA 8(A) CAIR Comprehensive Assessment Information Rules TSCA 8(A) Pair Preliminary Assessment Information Rules TSCA 8(C) Records ofAllegations ofSignificant Adverse Reactions TSCA 8(D) Health and Safety Reporting Rules TSCA 8(D) Health and Safety Reporting Rules Termination TSCA 12(B) Notices ofExport SARA 313 Chemicals Regulated Under §313 ofEPCRA See http://www.epa.gov/opptintr/CORR/index.htm. The petitioning associations are not aware ofany unmet information needs ofthe EPA, other federal agencies, tribes, states, local governments, or members ofthe public in light of: 0 FDAregulatory 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- 00144f67d031/DISS-9fdcaf46-0f58-4e27-e044-00144f67d031 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, ifany, priorto EPA's final action on the petitionrequest.

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 ofother complementary risk screening information). 

### The following table provides the status ofthe 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 lowtoxicitypesticide 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 ofthe 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 beenprovided to EPA. The key to EPA's Pesticide and Inert listings are as follows: 1=Inert Ingredients ofToxicological Concern 2 =Potentially Toxic Inert Ingredients/High Priority for Testing Inerts 3 = Inerts ofUnknown 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 ofcomparable 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 withthese substances which have already been shown to be "safe". More specific processing and use information is included in the data summaries at that section ofthis 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 ofthe chemical substance are adequately managed by EPA or another agency or authority) CRA is not aware ofany information to suggest that these agencies are inadequately managing the safe use ofCom Steep Liquor. The manufacturing and use ofthese substances primarily fall within thejurisdiction 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 ofthe petitioned substances as well. In addition, state environmental protection agencies have authority over facilities within theirjurisdictions
. As previously indicated, food uses ofthe petitioned components far exceed TSCA-regulated uses. Activities related to TSCA-regulated processing and use ofthe 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 

## 29

**h~i** 

## 7: 49 201-16714A



### AssessmentPlan for Corn SteepLiquor (CAS #66071-94-1) 

### in Accordance with theUSEPAHigh Production VolumeChemical Challenge Program

Preparedfor: The Corn RefmersAssociationRevisedApril24, 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 ANDACCEPTABILITY.................... ...... .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 LIQUORPROPERTIES ................. ....... .... ........... ..... .... 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 ofLiterature 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 ofthe water soluble components ofcorn 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 ofstandard 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 ofliquid 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 ofsulfur dioxide. Sources ofaqueous sulfur dioxide (e.g., sulfurdioxide, 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 ofsafe 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 ofcorn.

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 greaterthan 1million pounds per year. The hazard data to be provided in the program are those that meet the requirements ofthe Screening Information Data Set (SIDS) Program (OECD 1997). SIDS, which has been internationally agreed to by member countries ofthe Organization for Economic Cooperation and Development (OECD), provides the basic screening data needed for an initial assessment ofthe physical-chemical properties, environmental fate, and adverse human and environmental effects ofchemicals. The information for completing the SIDS can come from existing data ormay 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 ofanimals tested in the HPV Challenge Program whenever it is scientificallyjustifiable (USEPA 1999a, 2000). Therefore, this test plan evaluates all ofthe existing data for the sponsored chemical in an effort to adequately characterize the health and environmental hazard while reducing the number ofanimals 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 ofthe Corn Refiners Association are: ArcherDaniels 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 ofthe CRA's efforts and provides a summary and analysis of the available data, and identifies any data gaps in the SIDS dataprofile. The first section ofthis assessment plan provides an identification ofthe 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 ofdata gaps in the SIDS profiles for the sponsored chemical are presented.

3IDENTIFICATION 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 ofthe water soluble extracts ofcorn 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 (WetBasis) (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 oftotal 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 ofash 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 ofthese constituents provide natural nutrition for normal cell metabolism and are not a cause for concern. B. Production Process Corn steep liquor is a byproduct ofthe initial stages ofwet milling ofcorn. Steeping ofcorn (i.e., soaking i' n water) aids in the separation the various components ofcon1 such as starch and nutrients. Corn is normally steeped in stainless steel drums holding from 3,000-25,000 bushels ofcorn (CRA 2002; White and Johnson 2003). Approximately 5-9 gallons ofwater per bushel ofcorn 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 ofsulfur 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 ofsulfur dioxide form sulfurous acid, which controls fermentation and softens the corn kernel to aid in the separation ofthe 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% (Liggett and Koffler 1948). The corn is steeped for anywhere between 22-50 hours, while the CSL is moved through six to twelve successive steepingtanks. The CSL is initially added to the tankwith 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 ofthe water is absorbed by the corn during the steeping, and the othertwo-thirds is withdrawn from the steeping system as light steepwaterthat 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 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. The majority ofCSL 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 ofacetic 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 ofpenicillin 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% ofwet milled corn products (CRA 2006c). Worker exposure to CSL during its manufacturing is limited by the automation ofthe steeping process. The water is piped into the steeping tanks and from one tank to another. While small amounts ofinhalation are possible during the evaporation ofwater from the CSL, the vapor would contain mostly water as the solid fraction ofthe CSL would remain in the evaporation tanks. The low amount ofsulfurous 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 ofcorn 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



### 52006). Exposure might also be possible during the cleaning ofequipment used in the manufacturing process. Exposure during consumer use could occur when giving animals pre-mixed feeds or supplements containing CSL, or during pouring ofliquid 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 ofcorn steep liquor are natural to the corn except for the small amount ofsulfurous 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 occurwhen corn steep liquor is used in the manufacturing ofchemicals 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 ofthe CSL mixture. To supplementthe industry data, literature searches were conducted ofon-line databases 

### (e.g., Hazardous Substances Databank [HSDB], Registry of Toxic Effects ofChemical Substances [RTECS], and the USEPA's ECOTOX database), standard scientific data compendia 

### (e.g., CRCHandbook of Chemistry andPhysics and 

### The MerckIndex), 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 ofthe data in evaluating their usefulness for hazard assessment purposes. The Klimisch et al. (1997) approach specifies four categories ofreliability 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, orthat use non-relevant organisms or exposure routes, orwhich were carried out using unacceptable methods, or where documentation is insufficient. 4. NotAssignable: 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 professionaljudgment deemed it appropriate as part ofa weight-of-evidence approach. Because CSL is a mixture consisting ofthe water soluble crude proteins, amino acids, reducing sugars and other natural nutrients used in animal feed, and therefore, is ofvery 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 ofsafe nutritional supplement use ofCSL. A previous IUCLID Data Set for CSL was prepared by one ofthe 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 ofthe 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 othertechnical 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 of4 (not assignable) because the original reports were not available for review.



### 7Table 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 VaporPressure 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 ofwater. Because CSL results from the steeping (soaking) ofcorn in water, all ofthe individual constituents ofthe mixture are highly water soluble nutrients. Because ofthis 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 ofdegradation and how a material's properties affect its transport in the environment. For organic chemicals, fate is generally a function ofthe breakdown of compounds into smaller constituents by biological degradation. Otherbreakdown 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 ofchemicals 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 watercompartment. In addition, the individual components ofthe 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 orother aquatic organisms. CSL consists ofthe water soluble components ofcorn 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 ofCSL is as a nutrient source additive in animal feeds, and has a long history ofsafe 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 ofthe CSL mixture. In addition, CSL is used in the production ofacetic 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 overthe years to show the safety ofCSL in animals. CSL is used as a nutritive additive in a wide range ofanimal 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 ofData Completeness CSL has a long history (over 100 years) ofsafe use as a nutrient additive in animal feed and as a nutrient source in fermentation processes. Because ofthe lack oftoxicity concerns and the nutritional benefits ofCSL, standard guideline studies have notbeen completed. The safe use of CSL has been adequately established and therefore the CRA is not proposingto conduct additional guideline studies at this time. SUMMARY OF CORN STEEP LIQUORPROPERTIES Corn steep liquor is a viscous liquid mixture consisting entirely ofthe water soluble components ofcorn steeped in water, along with a small amount ofsulfurous acid (<0.0I%). 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, orhuman toxicity would be expected from these natural nutritive materials. CONCLUSIONS CSL has a long history ofsafe use as an added source ofnutrition in animal feed, in fermentation processes, and in antibiotic production. Because CSL consists ofnatural nutritive materials, there is very low toxicity concern. The CRA is not proposing to conduct additional testing on this natural water soluble extract ofcorn.

9

### REFERENCES ADM. 2002. Material Safety Data Sheet: Corn Steepwater. Archer Daniels Midland Company, Decatur, IL. August 2002. Budavari, S. (ed.). 1996. Merck Index (121h 

### 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 ofProducts ofthe 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 ofexperimental 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 ofPenicillin. 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 ofExisting Data. Draft guidance document dated February 10, 1999. USEPA. 1999c. Draft Guidance on Developing Robust Summaries. October 22, 1999. USEPA. 2000. Chemical Rightto 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 ofCereal Chernists.



### 11

### Appendix A: Summary ofLiterature 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 ofstudies ofusing corn steep liquorto 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 ofCSL 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 ofcorn 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.)


### I0. MHLW- 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 ofcritical reviews- No relevant information. 18. ECB

- European Chemicals Bureau -Norelevant 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. EFAST- 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

14Existing 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 ofRecipients
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 ofExposure 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. ofRendering 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: N ot a s i gnificant source of w ater pollution. 1.14.2 Major Accident Hazards Remark: N one 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: N one 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: N one

- 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 ofDegradation 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 Challenge endpoint . 4.8 Biotransformation and Kinetics Remark: Not an HPV C hallenge endpoint
. 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 RiskAssessment 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 ofPetitioned Substance

3 Chemical Name: CornSteepLiquor 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 ofExisting 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 ofPetitioned Substance 25 26 27 Composition ofthe Substance: 28 29 Steepingis a procedure used duringwetcornmilling. The major objectives for corn steeping areto induce 30 chemical and physical changes inthekernelbyleaching the solublecomponentsfrom the corn. Cleaned 31 shelled corn is soaked for 30-48 hours at 120- 130° Fina dilute sulfurdioxide solution. The steeped liquid 32 is then separated from thenon-soluble corn solids, which are further separated into germ, bran, starch, and 33 gluten protein. The steeped liquor is concentratedby evaporation into Condensed Corn Fermented 34 Extractives or CornSteepLiquor (CSL). Corn steep liquor is a mixture ofsoluble protein, amino acids, 35 carbohydrates, organic acids (e.g., lactic acid), vitamins, and minerals. 36 37 Wetcorn millingis used to produce numerous cornbased products that are subsequently used as biofuel, 38 ingredients infood, andfor livestockfeed. These products include starch, highfructose corn syrup, oil, 39 ethanol, bran, glutenfeed, and meal. Corn steep liquor is one ofthebyproducts ofcornwetmilling 40 directed to the production ofanimal feed. Itis also used as a nutrientfor microorganisms inthe 41 production ofenzymes, antibiotics, and otherfermentation products. 42 43 Properties ofthe Substance: 44 ProductChemistry Liquid Physical State MeltingPoint BoilingPoint 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 notflammable notexplosive Soluble inwater Technical Evaluation Report Compiledbythe Technical SeNices Branch for the USDA National Organic Program Page 1ofB45 46 47 48 4 Technical Evaluation Report 

# IOxidizer

50 Specific Uses ofthe Substance: 51 Corn Steep Liquor Crop Production not an oxidizer

52 CSL is a mixture ofsoluble proteins, amino acids, carbohydrates, organic acids (e.g., lactic acid), vitamins, 53 and minerals. Itis used as a nutrientfor microorganisms in the production ofenzymes, antibiotics, and 54 other fermentation products. It is sometimes combined with other ingredientsincornglutenfeed and 55 widely used incomplete feeds for dairy and beefcattle, poultry, swine, and petfoods. It may also be sold 56 separately as a liquid protein source for beefor dairyrations. 57 58 Approved Legal Uses ofthe Substance: 59 60 The Association ofAmerican Feed Control Officials, Inc. (AAFCO) haslisted corn step liquor as a livestock 61 feed ingredient. 62 63 The following is quoted directlyfrom the AAFCO homepage
. 64 65 "Thepurpose ofthe corporation shall be to establish and maintain anAssociation throughwhichofficials 66 ofany state, dominion, federal or other governmental agency and employees thereofcharged with a 67 responsibilityinenforcingthelawsregulatingthe production, labeling, distribution, or sale ofanimal feeds 68 or livestockremediesmay unite to explore the problems encounteredinadministering suchlaws, to 69 developjustand equitable standards, definitions and policies to befollowed inenforcing suchlaws, to 70 promoteuniformity in suchlaws, regulations and enforcementpolicies, and to cooperatewithmembers of 7 1 the industry producing suchproductsinorder to promote the effectiveness and usefulness of such 72 products." 73 74 Action ofthe Substance: 75 76 Corn steep liquoris a byproduct ofwetcom milling
. Its components are soluble proteins, amino acids, 77 carbohydrates, organic acids (e.g., lactic acid), vitamins, and minerals. Itis sometimes combined with 78 other ingredients incorn glutenfeed andwidelyused incompletefeeds for dairy and beefcattle, poultry, 79 swine, and petfoods. Some com steep liquor is used in the productionof acetic acid, food acids, and 80 fermentation processes. Somecom steep liquor is used in the pharmaceuticalindustry in the productionof 81 intravenous solutions and drugs, mostnotably antibiotics (penicillin). 8 2 83 84 Status 85 86 U.S. Environmental Protection Agency 87 88 Corn steep liquor is one of2800 HighProductionVolume (HPV) chemicals identified onthe US 89 EnvironmentalProtectionAgency's (USEPA) 1990Toxic 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 peryear. 92 93 The following information is quoted directly from the USEPA homepage for New Chemicals. 94 95 "Under theToxic Substances Control Act, section 8(b) provides EPA authority to "compile, keep current, 96 and publish a list ofeach chemical substance thatis 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 ofa February 1, 2010 Page 2ofBTechnical Evaluation Report Corn Steep Liquor Crop Production 98 particular molecularidentity, including

- (i) any combination of such substances occurringinwhole orin 99 partas a result of a chemical reaction or occurring in nature, and (ii) anyelement or uncombined radical." 100 TSCA does notinclude chemical substances subjectto other US statutes such as foods and food additives, 101 pesticides, drugs, cosmetics, tobacco, nuclearmaterial, or munitions." 102 103 U.S. Food and DrugAdministration 104 105 Corn steep liquoris notlisted as Generally Recognized as Safe by the FDA (FDA, 2004), butis listed as a 106 componentof a color additive allowed inchickenfeed. 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 ofalgae cells (genus Spongiococcum, 112 separated fromits culturebroth), molasses, cornsteep liquor, and a maximumof0.3 percentethoxyquin. 113 The algae cells are producedby 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 inchickenfeed in 116 accordance with thefollowing prescribed conditions: (1) The color additive is used to enhance 117 the yellow color ofchicken skin and eggs. (2) The quantity ofthe color additive incorporated inthefeed is 118 such thatthefinished feed: (i) Is supplemented sufficiently withxanthophyll and associated carotenoids 119 so as to accomplishthe intended effect described in paragraph (b)(1) ofthis section; and (ii) Meets the 120 tolerance limitationfor ethoxyquinin animal feed prescribed in§ 573.380 ofthis chapter." 121 122 Association ofAmerican Feed Control Officials, Inc. 123 124 The Association ofAmerican Feed Control Officials, Inc has listed corn steep liquor as a livestock feed ingredient. 125 126 International: 127 128 The EuropeanUnionpermitsthe use of stillage and stillage extracts asfertilizers and soil conditioners in 129 organic crop production, however, corn steep liquor is notmentioned specifically (EuropeanUnion, 2008). 130 Stillage is defined as the mashfrom thefermentation ofgrains after theremoval of alcoholby distillation 131 (Association ofAmericanFeed Control Officials, 2005). Maize branand glutenfrom wetcornmilling are 132 permitted as feed materials used in livestockproduction (EuropeanUnion, 2008). Europeanmanufacturers 133 refer to cornwet milling as maize processing. The processes are the same, whichincludes the use ofsulfur 134 dioxide. 135 136 The Codex Alimentarius permits the use of stillage and stillage extracts as fertilizers and soil conditioners 137 inorganic crop production, however, corn steep liquor is notmentioned specifically (Codex Alimentarius, 138 2008). 139 140 Corn steep liquor is included on the chemical inventory ofthe Domestic Substances Listby the Canadian 141 government. 142 143 Evaluation Questions for Substancesto be used in Organic Crop or Livestock Production 144 145 Evaluation Question #1: Is the petitioned substanceformulated ormanufactured by a chemical process? 146 (From 7 U.S.C. § 6502 (21).) 147 148 Corn steep liquor is produced by steeping corn grain inwater for up to 48 hours. The solublecomponents 149 in the corn are removed because a natural lactic fermentation is taking place during steeping. Sulfur 150 dioxide is added atrates of 0.1 to 0.2 percent and is used to cleave disulfide linkages, resultinginthe 151 degradation ofthe corn protein thatencapsulates the starchgranules. The starch is thenreleased from the 152 encapsulatingmaterial. The steep water containing the corn solubles are concentratedwithevaporators to February 1, 2010 Page 3ofBTechnical Evaluation Report Corn Steep Liquor Crop Production 153 form corn steep liquor. Corn steep liquoris a mixture ofsoluble protein, amino acids, carbohydrates, 154 organic acids (e.g., lactic acid), vitamins, and minerals. The nitrogenfraction is high infree amino acids 155 and small peptides. Infour samples ofcorn steep water, Hull etal., (1996) found a number of small poly156 peptidespresent. Concentrations ofpoly-peptides generally increased during steeping. In the same study, 157 Hull etal., (1996) found the amino acids glutamine, leucine, proline, and asparagine at the highest 158 concentrations. Lowerconcentrations oflysine, cysteine, and methioninewerereported
. Concentrations of 159 amino acids generally increased during steeping. The composition ofamino acids inthe 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-proteinnitrogenous compounds incorn steep water. 162 Enzymatic activities provided no evidence for proteases during steeping, however, the length of steeping 163 time (up to 30 hours), coupled withthehigher temperature (50 to 55 degrees Centigrade) and the presence 164 ofmicro-organisms could contribute to the enhancementofproteolytic activity during steeping (Hull et al., 165 1996). Corn steepliquor is very high in phosphorus,potassium, and sulfur (Kalscheur, et al., 2008). 166 167 Therefore, the chemical composition ofcorn steep liquor willprobablyvary and isreflective ofthe 168 processing strategyused by a particular manufacturer, depending onwhichcorncomponentthey are 169 interested inisolating. Factors affecting the composition ofCSL are cornhybrid, steeping time, 170 temperature, and the presence ofmicro-organisms. 171 172 Evaluation Question #2: Is the petitioned substanceformulated or manufacturedby a process that 173 chemicallychanges the substance extractedfrom naturally occurringplant, animal, ormineral sources? 174 (From 7 U.S.C. § 6502 (21).) 175 176 Corn steep liquor is derived from cornwhichis a naturally occurringplant. Cleancornis steepedin warm 177 water containing small amounts of sulfur dioxide. Soakingsoftensthe kernels and the dilute sulfurous 178 acid formed when the sulfur dioxide reacts withwater prevents excessive bacterial growth and loosens the 179 glutenbonds withinthe cornand releasesthe starch. The steepwater absorbs the soluble components and 180 is later evaporated and concentrated to a solid content ofabout50%. Asmentioned in the response to 181 Question 1, the chemical compositionofcorn steep liquorwillprobablyvary and isreflective ofthe 182 processing strategyused by a particular manufacturer, depending onwhichcorncomponentthey are 183 interestedin isolating. This is affected by steepingtime, temperaturereached duringthe lactic acid 184 fermentation, and the microbial environmentof thefermentation (Hull etal., 1996). Thesefactors will also 185 likely affect the quality ofthe fermentation end-products. 186 187 Evaluation Question #3: Is the petitioned substance createdbynaturally occurringbiological 188 processes? (From 7 U.S.C. § 6502 (21).) 189 190 Corn steepliquoris notcreated by a naturally occurringbiological process. Itis created as a result ofa 191 process designed to separate corninto itsfour basic components, starch, germ, fiber, and proteininan 192 aqueous medium
. Itis a complicated process ofchemical and biochemicalreactions that, despite the long 193 history ofthe wet-millingindustry, are still notfully understood. A summary ofthe process is provided in 194 evaluationquestion #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 notcause any environmentalcontamination, 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 wetcorn milling process that generates corn steep liquor may have some issues February 1, 2010 Page 4of8Technical Evaluation Report Corn Steep Liquor Crop Production 206 ofconcern related to environmental contamination. The wetmilling process is designed to separate the 207 corn intoitscomponents, starch, germ, protein (gluten) and fiber and convertthem into highervalue 208 products such as starch, high fructose corn syrup, corn oil, ethanol, bran, gluten feed, and meal. Itis the 209 making ofthe highvalue products thatresult in the generation ofmillions ofpounds ofwaste atwetcorn 210 millingplants annually. Ifthe waste is notmanaged properly itwill stress the environment. The USEPA 211 has funded a pilotprojectto assist small and medium-size manufacturers who wantto minimize their 212 generation ofwaste butwho lack the expertise to do so. For more information see: 213 http://www.p2pays.org/ref/02/01481.pdf. 214 215 Corn dustproduced during the handling and cleaningprocesses could be a safety hazard, due to thefact 216 thatthe corn dustis explosive. The organic materials used to extractthe corn oil from the germmaybe a 217 concern, due to accidental spills and the release ofvolatile organic compounds. There are no reported 218 incidences onenvironmental contamination due to the production ofcorn steep liquor. 219 220 Evaluation Question #5: Is the petitioned substanceharmful 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 notcause any environmental contamination, because the material is 224 approximately50% water and the soluble proteins, amino acids, carbohydrates, organic acids (e.g., lactic 225 acid), vitamins, and minerals would bereadilymetabolized and utilized by micro-organisms. Corn steep 226 liquorcouldbeused incrop productionto add organic matter and other nutrients to the soil, however, 227 there are probably other materials (animal manures) that are more cost effective. Corn steepliquor is used 228 inthe diets ofruminants (Kalscheur eta!., 2008)
. 229 230 Evaluation Question #6: Is there potentialfor 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 Thewater, soluble proteins, amino acids, carbohydrates, organic acids (e.g
., lactic acid), vitamins, and 234 minerals incorn steep liquor would be readily metabolized and utilized by microorganisms. Corn steep 235 liquor should notinteractchemicallywithother substances used inorganic crop or livestockproduction. 236 237 Evaluation Question #7: Are there adversebiological or chemical interactions inthe agro-ecosystem by 238 usingthe petitioned substance? (From 7 U.S.C. § 6518 (m) (5).) 239 240 Corn steep liquor shouldnotcause any adverse biological or chemical interactions inthe agro-ecosystem. 241 Therelease oflactic acid, whichcomprises 10 to 25% ofcorn steep liquor, to the environment, maybe an 242 issue, iflarge quantitieswere released to the environment. However, this would notbe expected since the 243 productionofcorn steep liquor is performedby a controlled process. Any lactic acid released to the 244 environmentwould be readilymetabolized and utilized as an energy sourceby 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 livestockbyusingthe petitioned substance? (From 7 U.S.C. § 6518 (m) (5).) 249 250 There is no informationavailable to indicate thatusing corn steep liquor has detrimental physiological 251 effects on soil, organisms, crops, or livestock. Because itis rich innutrients, it canbe applied to soils as a 252 fertilizer or soil conditioner and ithas 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 ofthe 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. Thecomponents ofcorn 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 ofwater in concentrated February 1, 2010 Page 5 of8Technical Evaluation Report Corn Steep Liquor Crop Production 261 form. However, the manufacturing ofcorn steep liquor is a controlled process and giventhe currentuses 262 ofcorn steep liquor, onewould notexpectlarge quantities ofcorn steep liquor beingreleased to bodies of 263 water. 264 265 Hull eta!., (1996) analyzed four differentcorn steep watersfor chemical composition. When analyzed for 266 heavy metals, iron was the mostprevalentheavy metal presentin corn steepwater. Chromium and 267 cadmium were notdetected in the four samples. Copper and nickel were detected atlevels approximately 268 5 to 10% ofthatof 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 orconcentration ofthe petitioned substance 271 or its breakdown products in the environment? (From 7 U.S.C. § 6518 (m) (2).) 272 273 The components ofcorn steep liquor are readily metabolized and utilized by micro-organisms as energy 274 sources, therefore, corn steep liquorwould notpersist and concentrate inthe natural environment. 275 276 Evaluation Question #11: Is there any harmful effect on human health byusingthe 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 ofcorn steep liquor are used 280 as ingredients infoods for humanconsumption (proteins, amino acids, carbohydrates, vitamins, and 281 minerals). Corn steep liquor has been successfullyfed to livestock for many years (Kalscheur eta!., 2008) 282 without any adverse effects onhuman 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 productthatcould be substitutedfor the petitioned 287 substance? (From 7 U.S.C. § 6517 (c) (1) (A) (ii).) 288 289 Inthe case ofadding organic matter to soils for crop production, composted and rawmanures could be 290 used depending onthe cropbeing grown, time ofharvest, and whether the crop will be used for human 291 consumption (Organic Materials Review Institute, 2007). For addinginorganic nutrients to soils, 292 unprocessed mined materialscould be used·(Organic Materials Review Institute, 2007). 293 294 Inthe case of supplementinglivestock feeds withvitamins and minerals, natural vitamin supplements and 295 non-synthetic minerals, respectively, canbe used (Organic Materials Review Institute, 2007). 296 297 Wetcorn milling is defined as corn steeped inwater with orwithout sulfur dioxide to soften the kernel in 298 order to facilitate the separation ofthevarious componentparts (Association ofAmericanFeed Control 299 Officials, 2005). Therefore, the wetcorn millingcould be conducted without sulfur dioxide, the lactic acid 300 fermentation and the subsequent separation of the corn components (includingnatural dryingto 301 concentrate the soluble materials inthe liquid portion) may be another method ofprocessing the corn. 302 This maybe an alternative to adding sulfur dioxide after the lactic acid fermentation and the concentrating 303 ofthe corn steep liquorwith evaporators. However, the quantities and quality ofthe end-products maybe 304 different. 305 306 Inthecase oforganic crop production, corn steep liquor would be used invery few, if any, products onthe 307 National List ofAllowed and Prohibited Substances. As in (7 CFR 206.601), herbicides (soap-based) for 308 use infarm stead maintenance and ornamental cropswould be a mixture ofeither calcium or sodium fatty 309 acids and corn steep liquor should notbe used in their manufacture. However, in the case oforganic 310 livestock production, trace mineral and vitamin supplements are allowed for enrichmentor fortification 311 when FDA approved. Iffeed ingredientmanufacturers use corn steep liquor to produce trace mineral and 312 vitamin supplements, this would be a significantuse ofcorn steep liquor in organic livestock production. 313 314 Evaluation Question #13: Are there other already allowed substances thatcould be substitutedfor the 315 petitioned substance? (From 7 U.S.C. § 6517 (m) (6).) February 1, 2010 Page 6ofBTechnical Evaluation Report Corn Steep Liquor Crop Production 316 317 As alternatives, organic cropproducers could use synthetic substances that are already allowed in organic 3I8 crop productionto 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 onthe crop of 321 interest and the micro-nutrientthatis in deficiency, some decision would have to be made aboutwhich 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 maintainproductive and healthy animals listed in 7 CFR 205
.603
. They 326 include thefollowing feed additives: 1) magnesium sulfate; 2) trace minerals (used for enrichmentor 327 fortification when approved by the FDA); and 3) vitamins (used for enrichment orfortification when 328 approved by the FDA). Depending on the livestock species and the micro-nutrient orvitamin thatis in 329 deficiency, some decision would have to be made aboutwhichonewould be the most appropriate to use. 330 Inbothcases (crop production and livestockproduction), the conditions for usingmaterials on the 331 National List ofSynthetic Substances mustbe documented inthe organic farming systemplan. 332 333 334 Evaluation Question #14: Are there alternative practices thatwould make the use ofthe petitioned 335 substanceunnecessary? (From 7 U.S.C. § 6517 (m) (6).) 336 337 As found in 7 CFR205.205, organic crop producers mustimplementa croprotationincludingbutnot 338 limited to sod, cover crops, green manure crops, and catchcrops thatprovidesfor maintaining and 339 improving soil organic mattercontentand managingdeficientorexcess plantnutrients. More specifically 340 7 CFR 205.203 states thatorganic cropproducers: 1) must selectand implementtillage and cultivation 341 practices thatmaintain or improve the physical, chemical, and biological conditionof soil and minimize 342 erosion; 2) mustmanage cropnutrients and soil fertility throughrotations, covercrops, and the application 343 ofplantand animal materials; and 3) mustmanage plantand animal materials to maintain or improve soil 344 organic mattercontentin a manner that does notcontribute to contamination ofcrops, soil, or waterby 345 plantnutrients, pathogenic organisms, heavymetals, orresidues ofprohibited substances. When these 346 practices proveinsufficientto preventdeficientor excess nutrients in soils orplants, a substanceon the 347 National List ofSynthetic Substances allowed for use inorganic cropproduction (7 CFR 205.601) may be 348 applied to maintainadequatenutrientsfor plantproductivity and health (see the informationinresponse 349 to Question13)
.. 350 351 As found in 7 CFR205.237, organic livestock producers mustprovide livestock with a total feed ration 352 composed ofagricultural products, includingpasture 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 informationinresponse to Question 13). 355 356 References 357 358 Association ofAmerican Feed Control Officials. 2005. Definitionofterms. Page 28. 2005 Official 359 Publication. Association of AmericanFeed Control Officials. 360 361 Codex Alimentarius. 2008. Guideline 32: Guidelines for the Production, Processing, Labelling, and 362 Marketing ofOrganically Produced Foods. 363 364 European Union. 2008. See: 365 http://eur-l ex.europa.euIL exUriServ/LexUriS rv.do?uri=CONSLEG:1991R2092:20071227: EN:PDF 366 367 Hull, S.R., B
.Y. Yang, D
.Venzke, K. Kulhavy, and R. Montgomery. 1996. Composition ofcorn steep water 368 during steeping. 

### J. Agric. Food Chern. 44:1857-1863. 369 February 1, 2010 Page 7of8T echnica/Evaluation Report Corn Steep Liquor Crop Production 370 Kalscheur, K, A. Garcia, K. Rosentrater, and C. Wright. 2008. Ethanol Co-products for RuminantLivestock 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 DrugAdministration. 2004. "Guidancefor Industry: FrequentlyAsked Questions About 376 GRAS," Centerfor FoodSafety and Applied Nutrition (CFSAN), December2004, Hypertextupdated 377 March 15,2006. Accessed at: http://www.cfsan.fda.gov/-dms/grasguid.html#Q1 378 379 Wilson, C.M. 1987. Proteins ofthekernel. In Corn: Chemistry and Technology; Watson, S.A. and P.E. 380 Ramsted, Eds.; Amer. Assoc. ofCereal Chemists; St. Paul, Minnesota; pages 273

- 310. 381

February 1, 2010 Page 8ofB