I. Comments

FHFA invites comments on all aspects of the proposed regulation and will take all comments into consideration before issuing the final regulation. Copies of all comments will be posted without change, including any personal information you provide, such as your name and address, on the FHFA Web site athttp://www.fhfa.gov.In addition, copies of all comments received will be available for examination by the public on business days between the hours of 10 a.m. and 3 p.m., at the Federal Housing Finance Agency, Fourth Floor, 1700 G Street, NW., Washington, DC 20552. To make an appointment to inspect comments, please call the Office of General Counsel at (202) 414-6924.

The Housing and Economic Recovery Act of 2008 (HERA), Public Law 110-289, 122 Stat. 2654 (2008), amended the Federal Housing Enterprises Financial Safety and Soundness Act of 1992 (12 U.S.C. 4501et seq.) (Safety and Soundness Act) to establish FHFA as an independent agency of the Federal Government.1 FHFA was established to oversee the prudential operations of the Federal National Mortgage Association, the Federal Home Loan Mortgage Corporation (collectively, Enterprises), the Federal Home Loan Banks (Banks) (collectively, regulated entities) and to ensure that they operate in a safe and sound manner; remain adequately capitalized; foster liquid, efficient, competitive and resilient national housing finance markets; comply with the Safety and Soundness Act and their respective authorizing statutes, as well as all rules, regulations, guidelines, and orders, issued thereunder; and carry out their missions through activities that are authorized by the above-cited statutes and are consistent with the public interest.

The Office of Federal Housing Enterprise Oversight (OFHEO) and the Federal Housing Finance Board (FHFB) will be abolished one year after enactment of HERA. However, the regulated entities continue to operate under regulations promulgated by OFHEO and FHFB until such regulations are supplanted by regulations promulgated by FHFA.

In 2005, OFHEO issued a regulation requiring the Enterprises to report mortgage fraud and to establish internal controls, procedures, and training programs to ensure that mortgage fraud is detected and prevented. As part of this rulemaking, that regulation, 12 CFR part 1731, “Mortgage Fraud Reporting,” would be removed when this regulation becomes effective.

Section 1379E of the Safety and Soundness Act (12 U.S.C. 4642(a)), subjects the regulated entities to both a reporting and an internal controls requirement. Under this statutory provision, the Director must require a regulated entity to submit a timely report upon discovery that it has purchased or sold a fraudulent loan or financial instrument, or suspects a possible fraud relating to the purchase or sale of any loan or financial instrument. In addition, the Director must require each regulated entity toestablish and maintain procedures designed to discover any such transactions.

Section 1379E of the Safety and Soundness Act (12 U.S.C. 4642(b)) also provides each regulated entity, and any entity-affiliated party, protection from liability in making a report, or requiring another to make any report, if it acts in good faith. This protection extends to any liability arising under any provision of law or regulation, any constitution, law, or regulation of any State or political subdivision of any State, or under any contract or other legally enforceable agreement (including any arbitration agreement) for the submission of any report or for any failure to notify persons who are the subject of, or who are identified in, the report.

In addition, Congress has continued to emphasize combating mortgage fraud as a key element in stabilizing mortgage markets and protecting homeowners and investors. The recently enacted Fraud Enforcement and Recovery Act of 2009, Public Law 111-21 (2009), provides new funding for anti-fraud efforts, enhances federal penalties and includes a review of the current financial and economic crisis.

Section 1313(f) of the Safety and Soundness Act (12 U.S.C. 4513(f)), requires the Director, when promulgating regulations relating to the Banks, to consider the differences between the Banks and the Enterprises with respect to the Banks' cooperative ownership structure, liquidity mission, affordable housing and community development mission, capital structure, and joint and several liability. The Director may also consider any other differences that are deemed appropriate. The purpose of this proposed rule is to implement statutory provisions that address possible risks to the regulated entities associated with fraudulent loans or other instruments. Although the respective businesses in which the Banks and the Enterprises are engaged differ, all of them are involved to some degree in providing financing to the residential mortgage market and thus may be exposed to the risk of fraud, particularly when investing in whole mortgage loans. In preparing the proposed regulation, the Director considered the differences between the Banks and the Enterprises as they relate to the above factors. The Director believes that none of the unique factors relating to the Banks warrants establishing different treatment under the proposed regulation. However, detailed guidance may be issued that would address specific business or operational differences with respect to the regulated entities. Nonetheless, the Director requests comments about whether it would be appropriate to include in a final rule any provisions relating to the differences between the Banks and the Enterprises.

This section as proposed would require each regulated entity to report to FHFA the discovery of fraud or possible fraud, in connection with a loan or other financial instrument that it has purchased or sold, and to establish internal controls, procedures, and training programs to detect and report such fraud.

This section provides definitions for the terms contained in the proposed regulation.

BankorFederal Home Loan Bankwould be defined as a Bank established under the Federal Home Loan Bank Act; the term “Federal Home Loan Banks” means, collectively, all the Federal Home Loan Banks.

Directorwould be defined as the Director of FHFA or his or her designee.

Enterprisewould be defined as the Federal National Mortgage Association, the Federal Home Loan Mortgage Corporation (collectively, Enterprises), and any affiliate thereof.

Entity-affiliated partywould be defined as—

• Any director, officer, employee, or controlling stockholder of, or agent for, a regulated entity;

• Any shareholder, affiliate, consultant, or joint venture partner of a regulated entity, and any other person, as determined by the Director (by regulation or on a case-by-case basis) that participates in the conduct of the affairs of a regulated entity, provided that a member of a Federal Home Loan Bank shall not be deemed to have participated in the affairs of that Federal Home Loan Bank solely by virtue of being a shareholder of, and obtaining advances from, that Federal Home Loan Bank;

• Any independent contractor for a regulated entity (including any attorney, appraiser, or accountant), if:

○ The independent contractor knowingly or recklessly participates in—

○ Such violation, breach, or practice caused, or is likely to cause, more than a minimal financial loss to, or a significant adverse effect on, the regulated entity;

• Any not-for-profit corporation that receives its principal funding, on an ongoing basis, from any regulated entity; and

• The Office of Finance.

Fraudwould be defined as a material misstatement, misrepresentation, or omission relied upon by a regulated entity.

Possible fraudwould be defined as a situation that a regulated entity has a reasonable belief, based upon a review of information available to the regulated entity, that fraud may be occurring or has occurred.

Regulated entitywould be defined as the Federal National Mortgage Association and any affiliate thereof, the Federal Home Loan Mortgage Corporation and any affiliate thereof, and any Federal Home Loan Bank; the term “regulated entities” means, collectively, the Federal National Mortgage Association and any affiliate thereof, the Federal Home Loan Mortgage Corporation and any affiliate thereof, and the Federal Home Loan Banks.

Safety and Soundness Actwould be defined as the Federal Housing Enterprises Financial Safety and Soundness Act of 1992, as amended by the Federal Housing Finance Regulatory Reform Act of 2008, Division A of the Housing and Economic Recovery Act of 2008, Public Law 110-289, 122 Stat. 2654 (2008).

This section as proposed sets forth the procedures for reporting fraud and possible fraud to FHFA, and requires a regulated entity to report promptly any fraud or possible fraud in writing to the Director. This section also provides that if the situation requires the immediate attention of FHFA, a regulated entity must report the matter to FHFA immediately by telephone or electronic communication. FHFA expects that it would issue guidance and instructions with respect to the format and content of fraud reports. This proposed section would allow the regulated entities to use fraud-reporting formats used by other agencies with jurisdiction over such fraud, but only upon receipt of written notice from the Director. For instance, under the Bank Secrecy Act of 1970, banking regulatory agencies require the completion and submission of Suspicious Activity Reports to the United States Department of the Treasury Financial Crimes Enforcement Network. The section as proposed would further provide for retention of records by a regulated entity and wouldprohibit the disclosure of reporting fraud or possible fraud to the parties connected with such fraud without the prior written approval of the Director. This requirement would not prevent a regulated entity from disclosing or reporting such fraud pursuant to legal requirements, including disclosure to appropriate law enforcement authorities. Finally, this section reiterates a statutory provision that makes clear that a regulated entity does not waive any privilege it may otherwise possess as a result of reporting fraud or possible fraud to FHFA under these provisions.

This section as proposed would require each regulated entity to establish adequate and efficient internal controls and procedures, as well as an operational training program, to assure that it has in place an effective system to detect and report any fraud.

This section as proposed would provide that a regulated entity and any entity-affiliated party that submits a report pursuant to this part, in good faith (or requires another person to submit such a report), cannot be held liable either for submitting the report, or for failing to notify any person who is the subject of such report, or is identified in the report.

This section as proposed would address that failure to comply with the requirements of the final regulation may subject a regulated entity or its board members, officers, or employees to supervisory action by FHFA under the Safety and Soundness Act, including but not limited to, cease-and-desist proceedings and civil money penalties.

As the proposed regulation pertains to the regulated entities, it does not contain any information collection requirement that requires the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. 3501et seq.).

The Regulatory Flexibility Act (5 U.S.C. 601et seq.) requires that a regulation that has a significant economic impact on a substantial number of small entities, small businesses, or small organizations must include an initial regulatory flexibility analysis describing the regulation's impact on small entities. Such an analysis need not be undertaken if the agency has certified that the regulation will not have a significant economic impact on a substantial number of small entities. 5 U.S.C. 605(b). In this case, the proposed regulation would apply only to the regulated entities, none of which are small entities for purposes of this requirement. Accordingly, FHFA hereby certifies that the proposed regulation is not likely to have a significant economic impact on a substantial number of small business entities for purposes of the Regulatory Flexibility Act.

Accordingly, for the reasons stated in the preamble, under the authority of 12 U.S.C. 4514, 4526, and 4642, the Federal Housing Finance Agency proposes to amend chapters XII and XVII of Title 12, Code of Federal Regulations, as follows:

1. Add part 1233 to subchapter B to read as follows:

On May 22, 2006, MMS published an Advance Notice of Proposed Rulemaking (ANPR) in theFederal Register(71 FR 29277) to seek comments and information on how to improve our regulatory approach to Safety and Environmental Management Systems (SEMS) for operations conducted in the Outer Continental Shelf (OCS). The ANPR examined a variety of approaches to implementing SEMS from voluntary to mandatory, and from partial SEMS to comprehensive SEMS.

During the ANPR comment period, eight comments were received from the public. One comment recommended keeping SEMS voluntary. Three comments recommended keeping SEMS voluntary, but if MMS decided to mandate a SEMS, it should be a partial SEMS requirement due to the number of accidents that are related to the four critical elements identified. A partial SEMS would consist of: Hazards Analysis, Management of Change, Operating Procedures, and Mechanical Integrity. The other four comments received recommended that MMS move forward with a comprehensive SEMS approach,i.e., the 12 elements listed in American Petroleum Institute's (API) Recommended Practice (RP) 75,Development of a Safety and Environmental Management Program for Offshore Operations and Facilities, Third Edition, May 2004. A comprehensive SEMS would consist of:

• Safety and environmental information;

• Hazards analysis;

• Management of change;

• Operating procedures;

• Safe work practices;

• Training;

• Mechanical integrity;

• Pre-startup review;

• Emergency response and control;

• Investigations of incidents;

• Auditing; and

• Records and documentation.

Most comments expressed that API RP 75 provides excellent guidance on developing a SEMS plan, and allows operators and contractors to tailor the program to their individual needs and corporate cultures. The commenters do not support MMS approving SEMS plans, rather, a third party should determine or certify whether a SEMS plan is viable, because MMS may not have the resources and expertise to approve a minimum of one plan for each OCS operator.

After reviewing and discussing the comments, MMS proposes to require each offshore lessee/operator to develop, implement, maintain, and operate under a SEMS program composed of the four elements. This decision was based on incident investigation findings, and performance reviews with operators which confirmed that the majority of the accidents on the OCS are related to the four elements in the proposed rule (i.e., Hazards Analysis, Management of Change, Operating Procedures, and Mechanical Integrity). Since the existing regulations (30 CFR 250) do not specifically address these four elements, MMS finds that it is appropriate to cover these SEMS elements in its rule. Each SEMS program would be tailored to the scale and complexity of the company's operation, and structured to include accountability for contractors and subcontractors. The SEMS program would describe management commitment to safety and the environment, as well as policies and procedures to assure safety and environmental protection while conducting OCS operations (including those operations conducted by contractor and subcontractor personnel). As company management and worker attitudes play a critical role in determining the safety of operations and environmental protection, a SEMS program would play a major role in focusing the attention of top management on safety and the marine and coastal environments. This will assure to the greatest extent possible, a broad organizational commitment to human safety and environmental protection.

The MMS proposes that the SEMS program contain the four elements mentioned above which are described in greater detail as:

This element would require that a hazards analysis (facility level) be conducted for all facilities. The purpose of the analysis is to identify, evaluate, and where unacceptable, reduce the likelihood and/or minimize the consequences of uncontrolled releases of oil and gas and other safety or environmental incidents. With respect to analysis methods, MMS suggests that operators use API RP 14 C,Recommended Practice for Analysis, Design, Installation, and Testing of Basic Surface Safety Systems for Offshore Production Platforms, Seventh Edition, March 2001;or API RP 14J,Recommended Practice for Design and Hazards Analysis for Offshore Production Facilities, Second Edition, May 2001,as guides, as well as other accepted documents and practices. In addition, this element would also require that a job hazard analysis (operations/task level) be performed to identify and evaluate hazards of a job/task for the purpose of hazards control or elimination.

This element would require lessees/operators to document and analyze all proposed facility changes to determine possible adverse safety and environmental impacts, with the exception of replacement in kind. There are a number of specific topics to be covered in this analysis, including changes in: facilities and procedures, personnel, work practices, equipment (including addition of new equipment or modifications to existing equipment), and the safety and environmental implications of these changes.

This element would require OCS oil and gas operators' management officials to include requirements for written facility operating procedures designed to enhance efficient, safe, and environmentally sound operations. While operating procedures are reviewed as part of MOC procedures, MMS would also recommend that these procedures be reviewed separately to ensure that they reflect current practices.

This element would require that procedures are in place to ensure that equipment is designed, fabricated, installed, tested, inspected, monitored, and maintained in a manner consistent with appropriate service requirements, manufacturer's recommendations, and industry standards to promote safe and environmentally sound operations in the OCS.

The proposed decision to require a SEMS program consisting of the four elements is based on incident investigation findings, an analyses of Incidents of Noncompliance (INC) data, performance reviews with operators, and the fact that existing MMS regulations do not address these four elements. Requiring operators to implement these four elements of an integrated SEMS program would address human factor issues in safety and environmental protection. Most industrial accidents and spills result from human error or organizational errors, not device or equipment failure. These four elements would address these types of accidents by encouraging the use of sound management principles and safety procedures.

The MMS's evaluation of safety information, which led us to the decision to require a SEMS program, included the following:

Accident panel investigation reports are prepared by MMS for select major accidents. An analysis of 33 accident panel reports prepared by MMS from 2000-2007 revealed that many fatalities and injuries occurred while performing routine tasks such as drilling, construction, coil tubing operations, and crane and other lifting events.

In addition, most of these accident panel reports made recommendations that relate to one of the following four SEMS elements: Hazards Analysis, Management of Change, Operating Procedures, and Mechanical Integrity.

The accident panel reports can be viewed at the following Web site address:http://www.gomr.mms.gov/homepg/offshore/safety/acc_repo/accindex.html

The table shows that the accidents covered by 16 of the 33 panel reports resulted in a combined 21 fatalities and injuries. The analysis done on the accidents identified six contributing causes that are related to the four elements: (1) A lack of communication between the operator and contractor(s); (2) no job hazard analysis was conducted prior to beginning work, or there was a lack of written procedures; (3) an onsite supervisor failed to enforce existing procedures or practices; (4) a lack of written safe work procedural guidelines; (5) integrity of the facilitiesand equipment were not maintained according to recommended practices; and (6) workplace hazards were not identified or corrected. The MMS maintains that at least some of these accidents could have been minimized or even prevented if the operator had implemented a SEMS.

The MMS also conducted a study of 1,443 incidents that occurred in OCS waters from 2001-2007 to determine if these events were associated with any of the 4 SEMS elements. The events reviewed included 41 fatalities, 302 injuries, 10 losses of well control, 11 collisions, 476 fires, 356 pollution events, and 224 crane and other lifting events (e.g., hoists, winches, etc.).

The majority of incidents occurring in the OCS were related to operational and maintenance procedures or human error. These incidents are not addressed by the hardware-oriented compliance inspections used by MMS OCS inspectors. Additionally, of the 1,443 incidents involving injuries, fires, and pollution on or from production facilities, only 25 were due to failure of a safety device. The majority of the 1,443 incidents had at least 1 of the following 4 elements as a contributing cause for the event occurring:

The MMS performed a root cause analysis of OCS spills over 50 barrels (bbls) from 2001-2007 with respect to the 4 elements. While root causes could be linked to failing to properly implement 1 of 4 elements, operating procedures and mechanical integrity contributed to the greatest number of these spills, and the 4 elements together could account for over3/4of the OCS spills.

The MMS inspectors issue three General INCs (G-INCs) that potentially relate to elements within a SEMS. The following summarizes these INCs:

• G-110 (Operations conducted in a safe and workmanlike manner),

• G-111 (Equipment maintained in a safe condition), and

• G-112 (Safety of personnel and all necessary precautions taken to correct and remove any hazards).

The MMS issued 3,132 of these types of G-INCs during 2003-2007 for drilling and production activities. Of these 3,132 G-INCs, 2,964 (approximately 95 percent) were directly related to one or more of the following four SEMS elements: Hazards Analysis (including job hazard analysis), Operating Procedures, Mechanical Integrity, and Management of Change. The following table depicts the G-INCs written for drilling and production activities:

The MMS also reviewed records of violations of Environmental INCs (E-INCs). The E-INCs focus on water quality as it relates to mud/oil/chemical spills and marine debris (E-100 thru E-202). Over the past 7 years, MMS has issued about 150 E-INCs for non-compliant production and drilling operations during field inspections each year. The data indicate no discernible trend of improvement by industry over the past 7 years (see the following tables covering 2001-2007).

The MMS has issued many other INCs that relate to environmental protection, including those that address flaring and venting violations, broad-based non-compliance with lease stipulations, approved plans, and permit applications. Similar trends to those previously described for the issuance of E-INCs are also observed in the issuance of other INCs that address environmental concerns.

As a result of MMS research conducted on accident panel investigations and reports, incident analysis, and INCs, it appears that equipment failure is rarely the primary cause of the incident or accident. This is due to technological advances which have provided industry with very efficient and reliable equipment for finding, producing, and transporting offshore oil and gas. However, in most cases, accidents and oil spills can be traced to human error and/or organizational failures. For that reason, operators must ensure that safe and environmentally sound operating practices are followed. The MMS finds it important to focus our efforts on ensuring that those who use the equipment do so safely and responsibly. More progress can be made toward achieving our goal of clean and safe OCS operations by concentrating on human behavior. The MMS regulations, historically, have focused on the installation, operation, testing, and inspection of safety and pollution prevention equipment, and risk based safety practices related to personnel. Ensuring proper equipment operation, however, does not necessarily ensure clean and safe operations. The research consistently points to the disproportionate contribution of human and organizational errors to accidents and oil spills. The MMS believes that operations are safer when management systematically encourages individuals to be safety conscious, provides adequate resources, fosters safe worksite practices, promotes good housekeeping habits, and assures that workers are properly trained. The MMS believes that if OCS oil and gas operations are better planned and organized, then the likelihood of injury to workers and the risk of environmental pollution will be further reduced.

While this proposed rule requires each offshore lessee/operator to develop, implement, maintain, and operate a SEMS program consisting of the 4 elements identified in this proposed rule, nothing prohibits the lessee/operator from adopting a more comprehensive SEMS approach as set forth in API RP 75. The MMS encourages industry to incorporate the comprehensive elements in their SEMS program.

In addition to industry complying with the 4 elements and electing to model their SEMS program after a comprehensive SEMS program such as API RP 75, lessees and operators are also encouraged to consider implementing the International Organization of Standardization (ISO) 9001,Quality Management Systems—Requirements; and ISO 14001,Environmental Management Systems—Requirements.

This proposed rule would require lessees and operators to have their SEMS program audited at least once every 3 years by either an independent third party or by qualified personnel designated within the company. A knowledgeable and experienced auditor would audit the SEMS program to determine if an OCS lessee and operator is complying with the SEMS plan. These audits would be conducted in an office environment and/or in the field, and cover both a broad range of activities or be focused on a particular area (e.g., records, gas compressors, blowout preventers, or documentation) as appropriate. Auditors must meet the qualifications as proposed in this rule.

The MMS may, at our discretion, evaluate independent third parties, meet with lessees and operators to periodically review the results of SEMS program audits, and conduct announced or unannounced evaluations with MMS personnel and/or independent third parties to determine SEMS plan compliance and effectiveness. The MMS would be more inclined to conduct a SEMS evaluation on an operator that has a history of poor performance. Poor performance may be based on the number and/or type of incidents of non-compliance, civil or criminal penalties, injuries, fatalities, accidents, fires, losses of well control, explosions, collisions, pollution incidents, and/or damage to the marine environment. Lessees and operators would be responsible for all costs associated with any independent third party evaluation of their SEMS plan.

In this proposed rule, MMS would require operators, on an annual basis, to submit the number of hours worked for all company and contract employees (people on the facility) during production, drilling, pipeline, and construction activities (which includes the adding or removing of equipment and/or facility modifications). This information is submitted on FormMMS-131 on an annual basis. We use the “hours worked” information to calculate Occupational Safety and Health Administration-style safety and health indices. The MMS considers the information to be significant to help us evaluate industry's continued improvement of safety and environmental management in the OCS. Information on Form MMS-131 includes company identification, number of company/contractor injuries and/or illnesses suffered, company/contractor hours worked, EPA National Pollutant Discharge Elimination System (NPDES) permit non-compliances and oil spill volumes for spills less than 1 barrel. All pieces of information are reported as collected during one calendar year. We use the information obtained from this form to develop industry average incident rates that help to describe how well the offshore oil and gas industry is performing. Using the produced data allows MMS to better focus our regulatory and research programs on areas where the performance measures indicate that operators are having difficulty meeting our expectations.

Additionally, operators can use the data to make individual comparisons and evaluate trends. Knowing how the offshore industry as a whole is doing, and where their own company ranks, provides company management with information to focus on safety and environmental improvement efforts. This information also provides offshore operators with a credible data source to demonstrate how industry and individual operators are performing.

The MMS does not want the SEMS program to be a paperwork exercise conducted solely to meet regulatory requirements. Such an effort would defeat the purpose of the proposed rule, which is to promote an attitude, or performance mentality, that helps to achieve operational safety and environmental protection through awareness and planning. The MMS knows that many lessee/operators have already integrated similar management programs into their operations and expects that most of the remaining operators have some type of informal or undocumented management program that addresses safety and environmental policies and procedures. The MMS understands that the development and implementation of this type of program may place an additional burden on some OCS operators, in the short-term. However, MMS believes that a SEMS program would benefit all lessees/operators in that it would identify and mitigate hazards, assure safe work practices, manage changes, and properly train offshore employees and contractors.

Comments on this proposed SEMS rule are requested. Commenters are encouraged to submit detailed comments with justifications or background information supporting their responses. In addition, we intend to conduct at least one public workshop on this proposed SEMS rule during the upcoming comment period. We will announce the time and location in a separate document.

This proposed rule is not a significant rule as determined by the Office of Management and Budget (OMB) and is not subject to review under E.O. 12866.

(1) This proposed rule would not have an annual effect of $100 million or more on the economy. The MMS estimates that it would cost OCS oil and gas lessees and operators $12,673,967 to comply with the requirements in the proposed rulemaking. This estimate includes the initial startup and development costs for lessees and operators to develop and implement the proposed four elements of a SEMS. This is a one-time cost of approximately $4,590,000. The MMS estimates that annual recurring cost of the proposed rulemaking to be approximately $8,083,967 for maintaining SEMS after implementation. Details on the estimated costs for this rulemaking are further discussed in the Regulatory Flexibility Act section. The proposed rulemaking would not adversely affect in a material way the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities.

(2) This proposed rule would not create a serious inconsistency or otherwise interfere with an action taken or planned by another agency.

(3) This proposed rule would not alter the budgetary effects of entitlements, grants, user fees, or loan programs or the rights or obligations of their recipients.

(4) This proposed rule would not raise novel legal or policy issues arising out of legal mandate, the President's priorities, or the principles set forth in E.O. 12866.

While the proposed rule would affect a substantial number of small entities, it would not have a significant economic effect on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601et seq.).

Small lessees/operators that operate under this rule fall under the Small Business Administration's (SBA) North American Industry Classification System (NAICS) codes 211111, Crude Petroleum and Natural Gas Extraction, and 213111, Drilling Oil and Gas Wells. For these NAICS code classifications, a small company is one with fewer than 500 employees. Based on these criteria, an estimated 70 percent (91 operators) of them are considered small. This proposed rule, therefore, would affect a substantial number of small entities.

In order to more accurately represent costs associated with implementing this rule, MMS made the following assumptions concerning the costs associated with the requirements in the proposed rulemaking.

• Because of the wide variation in company size, we have grouped operators into three classes (High, Moderate, and Low Activity).

• We have used the results of 10 years of voluntary SEMS Performance Measures reporting by OCS operators to determine that 70 of the 130 operators, at a minimum, are using SEMS. We suspect, however, that this number is higher based on previous Annual Performance Review Meetings where voluntary SEMS was a discussion topic.

• We have used actual costs from safety management system vendors to derive our estimated costs for industry.

• We assume there are no new costs for the estimated 70 operators who are currently using SEMS, as their systems have already been developed and they are expending funds to manage this process. However, we have calculated costs associated with compliance that require new work on their behalf and continued maintenance/recordkeeping activities.

• The estimated cost for the 60 remaining operators to implement, develop, and manage the SEMS program is based on the operator having an internet-based system, which has been determined to be the most common approach used by operators.

• Many operators are of such a modest size that a purchased template from a safety management system vendor would meet their needs and would comply with the proposed regulation. They would not need to spend additional money to customize a template for their use.

Oil and gas operators in the OCS vary substantially in size and the degree in which they are engaged in extracting oilfrom the OCS. Of the 130 identified operators, there is a range in OCS oil and gas activity from as little as 1 complex to nearly 500 facilities; and from as low as 15,000 barrels of oil equivalent (BOE) annual production to more than 300 million BOE annual production. Because of this tremendous variation in activity, MMS divides operators into high, moderate, and low activity for the purpose of measuring their performance. Using these same criteria (following this paragraph), we have used these size categories to estimate costs associated with developing, managing, and fulfilling reporting requirements for the proposed SEMS rule.

The criteria that categorizes an operator as a high, moderate, or low activity is as follows:

• An operator that qualifies under the high activity category would need to meet the following criteria:

• Produce at least 10 million or more BOE (MMBOE) per year.

• Operate a minimum of 1,000 in-service components or more during the year.

• An operator that qualifies under the moderate activity category would need to meet the following criteria:

• Produce at least 1 MMBOE, but less than 10 MMBOE, per year.

• Operate a minimum of 100 in-service components, but less than 1,000 in-service components during the year.

• An operator that qualifies under the low activity category would need to meet the following criteria:

• Produce less than 1 MMBOE per year.

• Operate less than 100 in-service components during the year.

After reviewing the voluntary SEMS submittals (OCS Performance Measures Data, Form MMS-131) received from 1996-2006, an average of 70 operators (54 percent = 70/130) reported having a SEMS-type program in-place. The other 60 operators (46 percent = 60/130) may not have a SEMS program in-place or may have a SEMS program but are not participating in the voluntary SEMS program.

The following table shows a breakdown by operator activity category (high, moderate, low):

As shown from the table, all high activity operators have a SEMS program in-place; the moderate activity shows over 70 percent are currently participating in a SEMS program; and finally, the low activity shows almost 40 percent are using a SEMS program.

Information received from consultants and vendors stated that the cost for an operator to buy a generic SEMS template is approximately $2,500. If an operator decided to modify the generic SEMS template to make it specific to their use, the cost would be an additional $10,000. As mentioned in the assumptions, many operators would not spend the additional $10,000 to customize a SEMS program for their use because it would not be necessary.

If the 60 operators without a SEMS program decided to buy a SEMS template, the cost would be $150,000 ($2,500 × 60). If all 60 operators needed to modify the generic plans for their specific OCS operations, which would be unlikely, an additional cost of $600,000 ($10,000 × 60) would be incurred to perform these modifications. The total for all 60 operators to buy a template and then modify the template to their philosophy is estimated at $750,000 ($150,000 + $600,000).

This section provides the estimated cost for industry to implement a SEMS. The following table shows a breakdown of the average number of facilities and components for the 3 operator activity levels:

The total cost for implementing the SEMS program considers only the 60 operators that do not have a functional SEMS program. The other 70 operators are already managing their SEMS program throughout the company.

A breakdown of the cost to implement and manage a SEMS program consisting of the four elements (i.e., hazards analysis, management of change, operating procedures, and mechanical integrity) was calculated for a moderate activity operator as follows:

• A hazards analysis for a moderate activity operator at the complex level (facility risk assessment) would cost approximately $102,000 for 29 facilities. This is a one-time implementation cost. In following years, this cost would be less because the rule requires that a hazards analysis be performed for changes in the process or the equipment on a facility. We estimate that the annual cost for a moderate activity operator to update a hazards analysis for the 29 facilities would be approximately $10,000 for 3 facilities (10 percent of 29 facilities).

• The job hazard analysis at the task level includes data collection, analysis, and report development. This cost is included in the hazards analysis.

• The MOC cost is based on one change request per month and it is dependent on the complexity of the change. The MOC cost will be determined by the physical state of thefacilities, the status of technology, and the turnover of personnel. The MOC would cost approximately $20,000 per year (includes the year to implement SEMS) which also includes MOC data collection, evaluation, and documentation update.

• Based on information from consultants and vendors, a lessee/operator would need to evaluate the operating procedures of their facility each year. Also, the operating procedure cost would be determined by the maintenance of such procedures. For most operators, no formal evaluation is necessary since changes will be identified through the job hazard analysis process and managed through the MOC process. Operating procedures will cost approximately $18,000 per year (includes the year to implement SEMS) which also includes data collection, evaluation, documentation update, and recordkeeping.

• The mechanical integrity cost is based on the assumption that mechanical integrity is achieved through preventive maintenance. The preventive maintenance program is defined prior to the commissioning of the facility. The cost of maintenance is not included in this assessment, only the cost of managing the program. Mechanical integrity will cost approximately $20,000 per year (includes the year to implement SEMS), which includes the quality assurance inspection plan, evaluation of schedule appropriateness, communication of maintenance program, salaries, maintenance and inspection reports, and recordkeeping.

• Auditing of the SEMS program is required once every 3 years and this cost would be approximately $15,000, for an average of $5,000 per year. This cost includes developing audit protocols, planning, performing audits, and recordkeeping. This is an annual cost after implementation of SEMS.

• The cost for report development, meetings, data collection, recordkeeping, and analysis would be approximately $13,000 per year. This is an annual cost after implementation of SEMS.

The estimated cost for a moderate activity operator to implement SEMS is $160,000. The estimated cost for the 12 moderate activity operators to implement SEMS is $1,920,000 ($160,000 × 12 operators). The itemized cost is:

The estimated average cost for a moderate activity operator to maintain their SEMS program is $86,000 a year. The estimated cost for the 12 moderate activity operators to initially maintain their SEMS program is $1,032,000. The itemized cost is:

Once all moderate operators have a SEMS program implemented, the estimated cost to maintain their SEMS program will be approximately $3,526,000 ($86,000 per operator × 41 moderate activity operators = $3,526,000).

A breakdown of the cost to implement and manage a SEMS program consisting of the four elements (i.e., hazards analysis, management of change, operating procedures, and mechanical integrity) was calculated for a low activity operator as follows:

• A hazards analysis for a low activity operator at the complex level (facility risk assessment) would cost approximately $22,000 for 6 facilities. This is a one-time implementation cost. In following years, this cost would be less because the rule requires that a hazards analysis be performed for changes in a process or equipment on a facility. We estimate that the annual cost for a low activity operator to update a hazards analysis would be approximately $2,000 for 1 facility.

• The job hazard analysis at the task level includes data collection, analysis, report development, and recordkeeping. This cost is already included in the hazards analysis.

• The MOC cost is based on one change request per month and it is dependent on the complexity of the change. The MOC cost would be determined by the physical state of the facilities, the status of technology, and the turnover of personnel. The MOC would cost approximately $5,000 per year (includes the year to implement SEMS) which also includes MOC data collection, evaluation, documentation update, and recordkeeping.

• Based on information from consultants and vendors, a lessee/operator would need to evaluate the operating procedures of their facility each year. Also the operating procedure cost would be determined by the maintenance of such procedures. For most operators, no formal evaluation is necessary since changes will be identified through the job hazard analysis process and managed through the MOC process. Operating procedures will cost approximately $5,000 per year (includes the year to implement SEMS) which also includes data collection, evaluation, documentation update, and recordkeeping.

• The mechanical integrity cost is based on the assumption that mechanical integrity is achieved through preventive maintenance. The preventive maintenance program is defined prior to the commissioning of the facility. The cost of maintenance is not included in this assessment, only the cost of managing the program. Mechanical integrity will cost approximately $8,000 per year (includes the year to implement SEMS), which also includes the quality assurance inspection plan, evaluation of schedule appropriateness, communication of maintenance program, maintenance, salaries, inspection reports, and recordkeeping.

• Auditing of the SEMS program is required once every 3 years and this cost would be approximately $6,000, for an average of $2,000 per year. This cost includes developing audit protocols, planning, performing audits, and recordkeeping. This is an annual cost after implementation of SEMS.

• The cost for report development, meetings, recordkeeping, and data collection and analysis would be approximately $6,000 per year. This is an annual cost after implementation of SEMS.

The estimated cost for a low activity operator to implement SEMS is $40,000. The cost for the 48 low activity operators to implement SEMS is $1,920,000 ($40,000 × 48 operators). The itemized cost is:

The estimated cost for a low activity operator to maintain their SEMS program is $28,000 a year. The cost for the 48 low activity operators to maintain SEMS is $1,344,000. The itemized cost is:

You may be interested in this action if you manufacture (defined by statute to include import) or process NP or NPEs. Potentially affected entities may include, but are not limited to:

• Chemical manufacturers (including importers) (NAICS codes 325, 32411, e.g., chemical manufacturing and petroleum refineries) of one or more of the subject chemicals.

• Surface active agent manufacturers (NAICS code 325613).

• Industrial launderers (NAICS code 81233).

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in Unit II.B. and Unit II.D.1. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed underFOR FURTHER INFORMATION CONTACT.

1.Submitting CBI. Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2.Tips for preparing your comments. When submitting comments, remember to:

i. Identify the document by docket ID number and other identifying information (subject heading,Federal Registerdate and page number).

ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

iv. Describe any assumptions and provide any technical information and/or data that you used.

v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

vi. Provide specific examples to illustrate your concerns and suggest alternatives.

vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

viii. Make sure to submit your comments by the comment period deadline identified.

EPA is publishing this ANPRM as a follow-up to its response to certain TSCA section 4 test rule development requests made to EPA by the petitioners under TSCA section 21. Under TSCA section 21, any person may petition EPA to initiate a rulemaking proceeding for the issuance, amendment, or repeal of a rule under TSCA sections 4, 6, or 8 or an order under TSCA sections 5(e) or 6(b)(2). In the petition filed under TSCA section 21 in June 2007, the petitioners’ requested that EPA require manufacturers and importers to conduct certain health and safety studies under TSCA section 4, and also requested certain TSCA section 6(a) actions for NP and NPEs (Ref. 1).

In its response to the TSCA section 21 petition (Ref. 2), EPA agreed that there may be a need for aquatic chronic toxicity testing for the short-chain NPEs. However, as EPA noted in its response, the particulars of a proposed testing program to evaluate aquatic toxicity of NPEs are uncertain, including which, and how many test chemicals and test species to include. In regard to an additional TSCA section 4 request, EPA denied that epidemiological testing is necessary, but did conclude that there may be a need for data to determine exposure to industrial laundry workers. However, EPA believes that additional information is needed to resolve:

1. Whether an exposure study (or studies) of industrial laundry workers' exposure to NPEs is warranted, and if so,

2. What kind of exposure study(ies) should be performed.

On October 24, 2007, the petitioners filed suit in the U.S. District Court for the Northern District of California (Ref. 56) challenging EPA’s denial of the requests in the TSCA section 21 petition. This lawsuit was mediated and, in an agreement signed on December 30, 2008, the parties settled the case (Ref. 57). As part of the settlement, the parties agreed to ask the Court to dismiss the case with prejudice within 10 days of the publication of this ANPRM. Copies of the original filing and the final settlement agreement are available in the docket for this action (Refs. 56 and 57).

The purpose of this ANPRM is to solicit public input and obtain additional information relevant to whether and what kind of testing to propose concerning aquatic toxicity testing of NP and NPEs, and also to solicit comment relevant to establishing the necessity for, and the type of studies useful to, determining exposure of industrial laundry workers to NPEs. EPA is also soliciting comment on the cost of the proposed testing and thecapacity of laboratories to conduct the testing.

The chemicals of concern in this ANPRM are NPEs, especially the short-chain NPEs, and NP. NP has little direct use itself, but is used as an intermediate to produce other chemicals, especially long-chain NPEs (Ref. 3). NPEs are manufactured by combining NP with ethylene oxide in an iterative process forming a mixture of NPEs of various chain lengths of 4 to 80 ethoxylate (EO) groups (e.g., NP4EO to NP80EO) (Refs. 3 and 4). Commercially, the commonly used NPEs have chain lengths of 8 to 12 EO groups (Ref. 5). Commercial mixtures of NPEs may contain a mixture of NPEs of various chain lengths; and NPEs may occur in either straight, or, more typically, branched forms. Different chain lengths have different properties and determine the particular industrial application and uses of the NPE substances. Common uses of NPEs include such consumer products as laundry detergents, shampoos, household cleaners and latex paints. Industrial uses include their use as surfactants, detergents, wetting agents and defoamers, among other uses (Refs. 3, 4, 6, and 7).

As described in this ANPRM, the testing EPA is considering is focused on aquatic toxicity testing for the short-chain NPEs, i.e., NP with one or two EO groups attached (NP1EO and NP2EO) and NP. As discussed in more detail in this unit, NP1EO, NP2EO, and NP occur in the environment mainly as degradation products of the longer-chain NPEs. In its response to the petitioners, EPA agreed that data concerning the toxic effects of the short-chain NPEs appear to be limited for aquatic organisms. In addition, for NP and short-chain NPEs, EPA concluded that there may be insufficient data to evaluate the effects of these substances on sediment-dwelling organisms. Data that are available indicate that these substances are highly toxic to fish and invertebrates, causing lethality on an acute basis and effects on growth, reproduction, and survival with low-level chronic exposures (Refs. 31 and 32). While data exist that are indicative of these effects, for the short-chain NPEs, and also for sediment-dwelling organisms, data may be insufficient for EPA to adequately evaluate the risk to aquatic and sediment-dwelling organisms from exposures to NP and short-chain NPEs. EPA also recognizes that at least part of the toxic mode of action for these substances may include disruption of the organism’s endocrine system. For purposes of risk assessment, the testing EPA is considering in this ANPRM may adequately account for these effects. However, as additional data and test methods become available, EPA may propose testing protocols to better address endocrine disruption effects specifically.

NPEs and NP as a class of compounds are considered to be inherently, though not readily, biodegradable and, compared to some other surfactants, are relatively resistant to biodegradation (Refs. 4 and 6). In the environment and in wastewater treatment facilities (WWTFs), the long-chain NPEs degrade relatively quickly when compared to short-chain NPEs and NP (Refs. 8-12). Short-chain NPEs are more resistant to further degradation to NP (Ref. 13). With sufficient time NP is ultimately degraded to CO2and water (mineralization), but this process is much longer that the degradation of NPEs to NP (Refs. 3 and 13-15). As a result, although most NPEs are used and released as long-chain NPEs, concentrations of short-chain NPEs and NP are relatively high compared to the long-chain NPEs in WWTF effluent and in environmental samples (Refs. 3, 4, and 16-24).

• A study by Rice et al. (2003) examined a 74 mile stretch of the Cuyahoga River, Ohio. They found that urbanized areas typically contain higher levels of NP and NPEs, with maximum concentrations found in water samples near WWTF discharge sites. At the sampling site closest to the Akron WWTF discharge location, 2.1 miles downstream, they found NP, NP1EO, NP2EO, and NP3EO at concentrations of 0.47, 0.60, 1.50, and 2.40 microgram/Liter (μg/L), respectively. However, the combined NP to NPE3EO concentrations in water samples at 7 additional sites along the river were much lower, with total concentrations ranging from only 0.13 to 1.0 μg/L (Ref. 22).

• Similarly, Barber et al. (2000) found detectable levels of combined NP, NP1EO, and NP2EO of 3.36 μg/L (fall samples) and 3.20 μg/L (spring samples) in the Des Plaines River, which is dominated by wastewater. However, these compounds were not detected further downstream in the Illinois River (the Des Plaines and Kankakee Rivers combine to form the Illinois R.), which receives much less WWTF effluent (Ref. 25).

• A comprehensive monitoring study of NP and NPEs in 30 U.S. rivers sponsored by the Chemical Manufacturers Association (now the American Chemistry Council (ACC)), was designed with the stated goal of characterizing the upper range of environmental NP and NPE concentrations in U.S. rivers (Refs. 21 and 49). This study found average levels of NP(3-17)EO (combined), NP2EO, NP1EO, and NP of 2.0 μg/L, 0.10 μg/L, 0.09 μg/L, and 0.12 μg/L, respectively, in water samples. The highest levels found were approximately 15 μg/L for NP(3-17)EO and 1 μg/L for each of the other substances measured. Most of the water samples contained non-detectable levels of NP and NPEs (level of detection approximately 0.1 μg/L for NP, NP1EO and NP2EO, and 1.6 μg/L for total NP(3-17)EO) (Ref. 21).

• In another study of 139 U.S. streams in 30 states conducted by the U.S. Geological Survey, NP, NP1EO, and NP2EO were 3 of 95 organic wastewater contaminants sampled for. Samples were taken downstream of areas anticipated to contain pollution from intense urbanization and livestock production. NP was one of the most frequently detected compounds (51%). NP1EO and NP2EO were also detected, though slightly less frequently (46% and 37%, respectively). For NP, NP1EO, and NP2EO the maximum detected concentration levels were 40 μg/L, 20 μg/L, and 9 μg/L, respectively, with the median estimated concentration of each substance being about 0.8 μg/L for NP, and 1 μg/L for NP1EO and NP2EO (Ref. 18).

NP and NPEs have also been reported in sediments. Because of their significant hydrophobicity, which increases with decreasing chain length, and relative resistance to degradation, which also increases with decreasing chain length, NPEs and especially NP and the short-chain NPEs tend to preferentially partition from water and accumulate in sediments at levels much higher than those reported in water (Refs. 3, 4, 6, 26, and 27). For example, Naylor et al. (1992) found that in sediment samples NP and NP1EO predominated (average levels of 162 μg/kilogram (kg) and 18.1 μg/kg, respectively), with the highest sediment levels being about 3,000 μg/kg for NP and 175 μg/kg for NP1EO (Ref. 21). Bennett and Metcalfe (1998, 2000) found NP to be widely distributed in lower Great Lakes sediments with concentrations as high as 37,000 μg/kg in sediments near sewage treatment plants (Refs. 28 and 29). Rice et al.(2003) measured sediment concentrations of NPEs and NP of 1,020 μg/kg dry weight in the Cuyahoga River, Ohio (Combined NP and NP(1-5)EO) (Ref. 22). Furthermore, in contrasting their observations with other published results, Rice et al. (2003) concluded that sediment levels of NPEs in the Cuyahoga River are low compared to some other areas; they noted, for example much higher levels were reported for the Detroit, Rouge, and Chicago Rivers (e.g., maximum reported levels of NP and/or NPEs from 49,000 to 60,000 μg/kg). In a marine/estuarine environment (Bernard Bayou, Mississippi), sediment concentrations ranged from 78 to 915 μg/kg for NP (average 509 μg/kg), and 5 to 89 μg/kg for NP1EO (average 11 μg/kg) (Ref. 49).

In WWTFs the degradation process of NPEs may vary depending on the efficiency of the WWTF and even according to the season of the year. However, even in cases where biodegradation of the long-chain NPEs is slowed (e.g., in winter or where wastewater treatment is poor), studies indicate that NP and the short-chain NPEs are still the predominant substances found after treatment (Refs. 3, 9, and 30).

EPA has identified a number of issues, on which it is specifically soliciting comment in regard to proposing aquatic toxicity testing for NP and NPEs. However, this is not intended as an exclusive list of issues and commenters are encouraged to provide comments on any issue pertaining to the aquatic toxicity of NP and NPE short-chain isomers, and the testing that may be necessary or appropriate. The issues on which EPA is specifically soliciting comments are:

• Selection of test substance identity and purity;

• Selection of extent of acute and chronic aquatic tests and test species;

• Selection of particular aquatic toxicity tests and test species for NPEs;

• Testing of NP in a saltwater fish species;

• Testing of NP and NPEs in freshwater and marine sediment; and

• Proposed testing for NP1EO and NP2EO as it relates to development of water quality criteria.

In the discussions in this unit, EPA indicates its preliminary considerations regarding these issues:

1.Selection of test substance identity and purity. Currently, the aquatic toxicity testing EPA is considering would focus on testing NP and the short-chain NPEs, i.e., nonylphenol with one or two ethoxylates groups attached. EPA is soliciting comment on the most appropriate selection and purity of NP and NPEs to test. At this time, considering presently available data on NP and NPEs, EPA believes that testing of NP (phenol, 4-nonyl-branched: CAS number 84852-15-3) and NP1EO and/or NP2EO of 95% purity (laboratory grade) is appropriate for purposes of sufficiently predicting environmental risks from NP and NPEs as a chemical category. As noted in Unit II.C., NP1EO, NP2EO and NP occur in the environment mainly as degradation products of the longer-chain NPEs and, because of their relative resistance to degradation compared to the longer-chain NPEs, these short-chain NPEs are commonly found in the aquatic environment (Refs. 22, 25, and 31). NPE toxicity also seems to increase with decreasing chain length (Refs. 32-34). Available toxicity studies indicate that the short-chain NPEs, for example, are about 100 times more toxic than the long-chain NPEs, and NP appears to be about 1.5 to two times more toxic than the short-chain NPEs (Refs. 3 and 35). In the environment, the alkylphenols are combinations of various isomers and congeners, including NP, which is a mix of substances in which the nonyl group may be branched or linear and which may be attached to the phenol ring ortho, meta, or para to the hydroxyl group (Ref. 4). The most predominant commercial NP substance for which EPA has developed aquatic life ambient water quality criteria is phenol, 4-nonyl-branched (CAS number 84852-15-3), but tests on NP with CAS number 25154-52-3 (phenol, nonyl) were also used in developing these criteria (Ref. 4). Determining which test substance to specify for testing is a more complex issue in regard to the short-chain ethoxylates. On the TSCA inventory, both NP1EO (CAS number 27986-36-3) and NP2EO (CAS number 27176-93-8) are described with the term “unspecified isomer lot.” EPA has also identified NP1EO (CAS number 104-35-8) and NP2EO (CAS number 27176-93-8) whose name and CAS numbers indicate linear forms of these substances (although the actual structure may be branched); the NP1EO so identified is not present on the TSCA inventory; the NP2EO is.

With regard to who might ultimately be responsible for testing of these substances, the approach that EPA is considering proposing is that all manufacturers and processors of NP and NPEs of any chain length would be responsible for the testing. However, EPA solicits comment on such an approach.

2.Selection of extent of acute and chronic aquatic tests and test species. For substances that are broadly distributed in the environment, as is the case for NP and NPEs, EPA’s OPPT, in assessing hazard to substances which are considered highly toxic, and EPA’s Office of Water (OW), in determining ambient water quality criteria, typically review test data for both freshwater and saltwater organisms (fish, invertebrates, and plants) in order to adequately predict aquatic toxicity to environmental species (Refs. 36-38 and 50 to 51). To further elucidate the aquatic toxicity of NP and NPEs, EPA is considering proposing a number of aquatic and sediment toxicity tests in fish, invertebrates and algae. Specific testing is discussed in more detail in this unit.

The petitioners requested testing of mixtures. EPA responded that, for purposes of evaluating the effects of mixtures of NP and NPEs, an assumption of additive toxicity was reasonable and a more pragmatic way to account for the toxicity of mixtures of these substances to aquatic organisms (Refs. 1 and 2). This is because if effects are additive, the effects of mixtures can be effectively predicted from toxicity studies done on single substances. Two recent papers have examined the issue of additive toxicity for NP and NPEs. These papers present test results for mixtures of NP and the short-chain NPEs on fathead minnows and two species of daphnids, planktonic freshwater crustaceans also known as water fleas (Refs. 52 and 53). TenEyk and Markee (2007) concluded from testing with fathead minnows (Pimephales promelas) and water fleas (Ceriodaphnia dubia) that both potential additivity and synergism (where toxicity of the mixture is greater than additive) were observed (Ref. 52). Conversely, in tests with another water flea species (Daphnia magna), Sun and Gu (2005) concluded that potential antagonism (where toxicity of the mixture was less than additive) was seen (Ref. 53). EPA notes that these testing results indicate the substantial difference in the conclusions regarding the type of interaction (antagonism vs. additivity vs. synergism) that can potentially occur due to any number of factors related to biology, chemistry, experimental variables, etc. However, in considering the limitations associated with the study designs, EPA notes that, in both studies, the deviations observed from a simple additivity interaction are sufficiently small (a factor of approximately two or less) as to make additivity a reasonableassumption for any evaluation of these compounds at this time. Two-fold is well within the range of inter-laboratory variability that one might expect in the results of testing a single chemical in the same species from one laboratory to another, and is far lower than the variability observed for toxicity of the same chemical to different aquatic species, which, in the case of NP, can exceed 100-fold (Refs. 32 and 55).

Therefore, it is EPA’s current view that testing of individual NP and NPE substances as EPA is considering proposing in this ANPRM, will provide sufficient information needed to evaluate the toxicity of mixtures of these substances (for example, by using a toxic equivalent factor (TEF) approach). However, EPA is soliciting comment on whether testing intended to address the potential for additive toxicity should be conducted consistent with the protocol used in the TenEyck and Markee study (Ref. 52), as suggested by the petitioners. EPA is also soliciting comment on alternative approaches to investigating the potential toxicity of mixtures of NP and the various short-chain NPEs.

3.Selection of particular aquatic toxicity tests and test species for NPEs. To further determine the aquatic toxicity of NPEs, EPA is considering proposing chronic testing in freshwater fish, both warm and coldwater species (e.g., fathead minnow,Pimephales promelas, and rainbow trout,Oncorhynchus mykiss); chronic testing in a freshwater invertebrate (e.g.,Daphnia magna); and testing in freshwater algae (e.g.,Pseudokirchneriella subcapitata; formerlySelenastrum capricornutum). EPA is also considering testing in a saltwater fish (e.g., sheepshead minnow, (Cyprinodon variegatus), chronic testing in a saltwater invertebrate (e.g., mysid shrimp,Mysidopsis bahia), and testing in saltwater algae (e.g.,Skeletonema costatum)). In order to set appropriate test concentration levels, and to develop-acute-to-chronic ratios, EPA is also considering acute testing be performed by the same laboratory doing the chronic fish and invertebrate testing.

4.Testing of NP in a saltwater fish species.EPA has developed water quality criteria (WQC) for NP (Ref. 4). However, as EPA noted in that document, the WQC for NP (CAS number 84852-15-3) was developed without adequate chronic toxicity data for a saltwater fish species. EPA is therefore considering proposing that acute and chronic toxicity testing of NP be performed in a single laboratory in order to fill that missing chronic toxicity data need, and also to calculate an acute-to-chronic ratio. EPA is considering proposing that the sheepshead minnow be the test species for this possible testing requirement.

5.Testing of NP and NPEs in freshwater and marine sediment. EPA noted in its response to the NP-NPE TSCA section 21 petition that information on the toxicity of NP in sediment, in both freshwater and marine/estuarine habitats, is limited and that it would consider additional testing under TSCA section 4 to obtain needed data. EPA is considering proposing acute and chronic sediment toxicity testing in freshwater and marine species of benthic invertebrates for NP, NP1EO, and/or NP2EO, where adequate data are lacking. Specifically, EPA is considering proposing the amphipod (Hyalella azteca) as the freshwater test species (acute and chronic testing) (Ref. 39). EPA is also requesting, as per the discussion in Unit II.D.2., comment on whether to require section 4 testing of NPE and NP on a sediment organism, e.g.,Hyalella azteca, in order to fill the information gaps on additive toxicity. Regarding the marine environment, EPA is considering proposing testing in two species: acute testing in a marine amphipod (Rhepoxynius abronius), which, besides being a purely marine species, has a large data base of toxicity testing available; and acute and chronic testing in an estuarine amphipod, (Leptocheirus plumulosus) (Refs. 40 and 41). EPA would consider using the results from bothLeptocheirusandRhepoxyniusto estimate chronic toxicity toRhepoxynius, for which a chronic toxicity test method is not available.

6.Proposed testing for NP1EO and NP2EO as it relates to development of water quality criteria. EPA has derived recommended ambient water quality criteria (AWQCs) only for NP (Ref. 4). An EPA-recommended AWQC is a level of a pollutant or other measurable substance in water that, when met, will protect aquatic life and/or human health. EPA publishes recommended AWQCs pursuant to Section 304(a) of the Clean Water Act, which directs EPA to publish criteria accurately reflecting the latest scientific knowledge on such factors as “the kind and extent of all identifiable effects . . . expected from the presence of pollutants in any body of water.” 33 U.S.C 1314(a)(1)(A). As discussed in this unit, NP is more persistent and toxic, and frequently more abundant in the environment, than NPEs. Because of its relative persistence and toxicity compared to NPEs, most research has focused on NP as a chemical substance of concern. For these same reasons, development of data for NP was considered of priority importance for derivation of AWQCs. (Development of AWQC generally involves extensive and specific test data (Refs. 4 and 38)). In this ANPRM, EPA is considering proposing more limited testing that would sufficiently characterize the toxicity of NP1EO and NP2EO to enable a reasoned assessment of risk from these substances. However, the data developed could also be useful to OW should they pursue development of NPE AWQCs.

The petitioners requested that EPA conduct an epidemiology study of industrial laundry workers who may be exposed to NP and NPEs in detergents. As noted in EPA’s response to the petition, before an epidemiology study can be effectively designed or conducted, there needs to be sufficient exposures to a substance to warrant a study of human health effects potentially attributable to those exposures. As noted in the comments submitted by the Uniform and Textile Service Association (UTSA) and the Textile Rental Services Association (TRSA), approximately 90% of industrial laundries use injected liquid detergent (Ref. 42). Given the low volatility (Ref. 43) and negligible dermal absorption of NP and NPE (Ref. 44), EPA does not expect that where liquid detergents are used these industrial laundry operations will present a significant exposure potential to workers. However, as agreed to in the Settlement Agreement (Ref. 57), EPA is soliciting comment on that conclusion in this ANPRM. Additionally, EPA is soliciting information on specific circumstances or scenarios which may result in workers being exposed. Examples included exposure scenarios resulting from spills. EPA would be interested in the extent to which those types of exposures would present risks to workers. EPA would also be interested in receiving comments on the best ways to obtain data or information on such exposures.

For the approximately 10% of industrial laundry operations and an unknown number of institutional laundry operations that may use powdered detergent, EPA believes there is potential for inhalation exposure to dust containing NP and NPE by workers and that the number of potentially exposed workers involved could be substantial (Ref. 45). As these concerns are based on estimates, not actual exposure monitoring data, they would not support a conclusion that there are sufficient exposures to warrant anepidemiology study. However, EPA considers that obtaining additional exposure information may be warranted to reasonably assess the potential for risk associated with this exposure scenario in particular.

EPA has examined the regulatory status, as well as other studies, of various components of detergents that are used in consumer, industrial, and institutional laundry operations (Refs. 46, 47, and 48). Exposure limits for subtilisins, enzymes used in detergent formulations, have been established by the American Conference of Industrial Hygienists (ACGIH) and the National Institute for Occupational Safety and Health (NIOSH). Air monitoring to ensure the levels are maintained is recommended and personal monitoring equipment for subtilisins or other common enzyme detergents is available (Ref. 47). In addition, the Organization for Economic Co-operation and Development (OECD) Screening Information Data Set (SIDS) report on linear alkyl sulfonates, another common laundry detergent component, suggests that the hazard warnings and routine practices (protective equipment use and rinsing of residuals from contact) will sufficiently limit exposure and subsequent absorption (Ref. 48). The potential for exposure to NP based chemicals in detergents should already be mitigated by the policies in place for the other detergent components. However, based on EPA’s draft engineering report (Ref. 45), EPA believes that specific monitoring for NP or NPE, using the analogous methodology for monitoring enzyme exposure, may be warranted to ensure that these routine practices are also protecting from NP exposures.

Accordingly, while EPA denied the petitioners’ specific request for an epidemiology study, EPA is soliciting comment on the best means to obtain information on NP and NPE exposures of laundry workers, especially where powdered detergents are used (e.g., whether through requiring an exposure study, workplace exposure monitoring, the voluntary submission of existing monitoring data, or other means). In addition, although EPA does not believe it has evidence sufficient to support the same level of concern for liquid detergents as for powdered detergents, EPA is soliciting comment on whether and how to obtain data on specific scenarios that may result in exposure to laundry workers from liquid detergents, as well as powdered detergents.

EPA is issuing this ANPRM on certain health and environmental effects testing for certain NP and NPE chemical substances under TSCA section 4(a) (15 U.S.C. 2603(a)).

Section 2(b)(1) of TSCA (15 U.S.C. 2601(b)) states that it is the policy of the United States that “adequate data should be developed with respect to the effect of chemical substances and mixtures on health and the environment and that the development of such data should be the responsibility of those who manufacture [which is defined by statue to include import] and those who process such chemical substances and mixtures[.]” To implement this policy, TSCA section 4(a) provides that EPA shall require by rule that manufacturers and processors of chemical substances and mixtures conduct testing if the Administrator finds that:

If EPA makes these findings for a chemical substance or mixture, the Administrator shall require that testing be conducted on that chemical substance or mixture. The purpose of the testing would be to develop data about the substance’s or mixture’s health and environmental effects for which there is an insufficiency of data and experience, and which are relevant to a determination that the manufacture, distribution in commerce, processing, use, or disposal of the substance or mixture, or any combination of such activities, does or does not present an unreasonable risk of injury to health or the environment. (15 U.S.C. 2603(a))

Once the Administrator has made the relevant findings under TSCA section 4(a), EPA may require any type of health or environmental effects testing necessary to address unanswered questions about the effects of the chemical substance. EPA need not limit the scope of testing required to the factual basis for the TSCA section 4(a)(1)(A) or (B) findings as long as EPA also finds that there are insufficient data and experience upon which the effects of the manufacture, distribution in commerce, processing, use, or disposal of such substance or mixture or of any combination of such activities on health or the environment can reasonably be determined or predicted, and that testing is necessary to develop such data. This approach is explained in more detail in EPA’s TSCA section 4(a)(1)(B) Final Statement of Policy published in theFederal Registerissue of May 14, 1993 (58 FR 28736, 28738-28739) (B Policy).

1. Ettinger, A.; Geertsma, M.; Hopkins, E.; Neltner, T.; Dickey, P.; Grader, Z.; McCally, M.; and Frumin, E. 2007. Letter from Environmental Law and Policy Center, Sierra Club, Washington Toxics Coalition, Pacific Coast Federation of Fisherman’s Associations, Physicians for Social Responsibility, and UNITE HERE to Stephen Johnson, Administrator, Environmental Protection Agency. Re: Citizen Petition to EPA Regarding Nonylphenol and Nonylphenol Ethoxylates. June 5, 2007.

2. EPA. TSCA Section 21 Petition on Nonylphenol and Nonylphenol Ethoxylates; Response to Citizens’ Petition. Notice.Federal Register(72 FR 50954, September 5, 2007) (FRL-8146-2). Available on-line athttp://www.epa.gov/fedrgstr.

3. Environment Canada. Canadian Environmental Quality Guidelines for Nonylphenol and its Ethoxylates (Water, Sediment, and Soil). Scientific Supporting Document. Ecosystem Health: Science-based Solutions Report No. 1-3. National Guidelines and Standards Office, Environment Canada, Ottawa. 189 pp. August 2002.

4. EPA. 2005. Aquatic Life Ambient Water Quality Criteria—Nonylphenol Final. U.S. Environmental Protection Agency, Office of Water, Washington, DC. EPA-822-R-05-005. 96 pp.

5. Reed, H.W.B. 1978. Alkylphenols. Pp. 72-96. In: Grayson, M.; Eckroth, D.; Mark, H.F.; Othmer, D.F.; Overberger, C.G., and Seaborg, G.T. (eds). Kirdk-Othmer Encyclopedia of Chemcial Technolgy. 3rdEdition. Volume 2. John Wiley and Sons, New York, NY.

6. European Commission—Joint Research Centre. Institute for Health and Consumer Protection. European Chemicals Bureau. 2002. European Risk Assessment Report. 4-nonyl-phenol (branched) and nonylphenol. CAS No: 84852-15-3, 25154-52-3. EINECS No.: 284-325-5, 246-672-0. Series: 2ndPriority List, Volume 10. Final Report.

7. Metcalfe, C.; Hoover, L.; and Sang, S. 1996. Nonylphenol ethoxylates and their use in Canada. World Wildlife Fund Canada, Toronto.

8. Giger, W.; Brunner, P.H.; and Schaffner, C. 1984. 4-Nonylphenol in sewage sludge: Accumulation of toxic metabolites from nonionic surfactants.Science. 225:623-625.

9. Ahel, M.; Hrsak, D.; and Giger, W. 1994a. Aerobic transformation of short-chain alkylphenol polyethoxylates by mixed bacterial cultures.Archives of Environmental Contamination and Toxicology. 26:540-548.

10. Ahel, M.; Giger, W.; and Koch, M. 1994b. Behaviour of alkylphenol polyethoxylates surfactants in the aquatic environment.Water Research. 28:1131-1142.

11. Naylor, C.G. 1995. Environmental fate and safety of nonylphenol ethoxylates.Textile Chemist and Colorist. 27:29-33.

12. Komori, K.; Yuji, O.; Yasomima, M.; Suzuki, Y.; and Tanaka, H. 2005. Occurrence of nonylphenol, nonylphenol ethoxylate surfactants and nonylphenol carboxylic acids in wastewater in Japan.Technology. 305-310.

13. Maguire, R.J. 1999. Review of the persistence of nonylphenol and nonylphenol ethoxylates.Water Quality Research Journal of Canada. 34:37-78.

14. Staples, C.A.; Williams, J.B.; Blessing R.L.; and Varineau, P.T. 1999. Measuring the biodegradability of nonylphenol ether carboxylates, octylphenol ether carboxylates and nonylphenol.Chemosphere. 38:2029-2039.

15. Staples, C.A.; Naylor, C.G.; Williams, J.B.; and Gledhill, W.E. 2001. Ultimate biodegradation of alkylphenol ethoxylate surfactants and their biodegradation intermediates.Environmental Toxicology and Chemistry. 20:2450-2455.

16. Bennie, D.T.; Sullivan, C.A.; Lee, H.; Peart, T.E.; and Maguire, R.J. 1997. Occurrence of alkylphenols and alkylphenol mono- and di-ethoxylates in natural waters of the Laurentian Great Lakes basin and the upper St. Lawrence River.Science of the Total Environment. 193:263-275.

17. Bennie, D.T. 1999. Review of the environmental occurrence of alkylphenols and alkylphenol ethoxylates.Water Quality Research Journal of Canada. 34:79-122.

18. Kolpin, D.W.; Furlong, E.T.; Meyer, M.T.; Thurman, E.M.; Zaugg, S.D.; Barber, L.B.; and Buxton, H.T. 2002. Pharmaceuticals, hormones and other organic wastewater contaminants in U.S. streams, 1999-2000: A national reconnaissance.Environmental Science and Technology. 36:1202-1211.

19. Lee, H.-B. and Peart, T.E. 1995. Determination of 4-nonylphenol in effluent and sludge from sewage treatment plants.Analytical Chemistry. 67:1976-1980.

20. Naylor, C.G. Environmental fate of alkylphenol ethoxylates.Soap Cosmetics Chemical Specialties. August 1992.

21. Naylor, C.G.; Mieure, J.P.; Adams, W.J.; Weeks, J.A.; Castaldi, F.J.; Ogle, L.D.; and Romano, R.R. 1992. Alkylphenol ethoxylates in the environment.Journal of the American Oil Chemists’ Society. 69:695-708.

22. Rice, C.; Schmitz-Afonso, I.; Loyo-Rosales, J.; Link, E.; Thoma, R.; Fay, L.; Altfater, D.; and Camp, M. 2003. Alkylphenol and alkylphenol ethoxylates in carp, water, and sediment from the Cuyahoga River, Ohio.Environmental Science and Technology. 37:3747-3754.

23. Sabik, H.; Proulx, S.; Gagne, F.; Blaise, C.; Marcogliese, D.; Chiron, S.; and Jeannot, R. 2000. Estrogenic compounds in the St. Lawrence River near Montral: occurrence and bioaccumulation by mussels (Elliptio complinata). Annual meeting of the International Association for Great Lakes Research (IAGLR). May 22-26, 2000. Cornwall, Ontario.

24. Sekela, M.; Brewer, R.; Moyle, G.; and Tuominen, T. 1999. Occurrence of an environmental estrogen (4-nonylphenol) in sewage treatment plant effluent and the aquatic receiving environment.Water Science and Technology. 39:217-220.

25. Barber, L.B.; Brown, B.K.; and Zaugg, S.D. 2000. Potential endocrine disrupting organic chemicals in treated municipal wastewater and river water. Pp. 97-123. In: Keith, L.H.; Jones-Lepp, T.L.; and Needham, L.L. (eds). Environmental Endocrine Disruptors, ACS Symposium Series 747. American Chemical Society, Washington, DC.

26. John, D.M.; House, W.A.; and White, G.F. 2000. Environmental fate of nonylphenol ethoxylates: differential adsorption of homologs to components of river sediment.Environmental Toxicology and Chemistry. 19:293-300.

27. Bennie, D.T.; Sullivan, C.A.; Lee, H.-B.; and Maguire, R.J. 1998. Alkylphenol polyethoxylates metabolites in Canadian sewage treatment plant waste streams.Water Quality Research Journal of Canada. 33:231-252.

28. Bennet, E.R. and Metcalfe, C.D. 1998. Distribution of alkylphenol compounds in Great Lakes sediments, United States and Canada.Environmental Toxicology and Chemistry. 17:1230-1235.

29. Bennet, E.R. and Metcalfe, C.D. 2000. Distribution of degradation products of alkylphenol ethoxylates near sewage treatment plants in the lower Great Lakes, North America.Environmental Toxicology and Chemistry. 19:784-792.

30. Loyo-Rosales, J.E.; Rice, C.P.; and Torrents, A. 2007. Fate of octyl- and nonylphenol ethoxylates and some carboxylated derivatives in three American wastewater treatment plants.Environmental Science and Technology. 41:6815-6821.

31. Staples, C.; Mihaich, E.; Carbone, J.; Woodburn, K.; and Klecka, G. 2004. A weight of evidence of the chronic ecotoxicity of nonylphenol ether carboxylates and nonylphenol.Human and Ecological Risk Assessment. 10:999-1017.

32. Servos, M.R. 1999. Review of the aquatic toxicity, estrogenic responses and bioaccumulation of alkylphenols and alkylphenol polyethoxylates.Textile Chemist and Colorist. 27:29-33.

33. Yoshimura, K. 1986. Biodegradation and fish toxicity of nonionic surfactants.Journal of the American Oil Chemists’ Society. 63:1590-1596.

34. Staples, C.A.; Weeks, J.; Hall, J.F.; and Naylor, C.G. 1998. Evaluation of aquatic toxicity and bioaccumulation of C8- and C9-alkylphenol polyethoxylates.Environmental Toxicology and Chemistry. 17:2470-2480.

35. Canadian Council of Ministers of the Environment. 2001. Canadian water quality guidelines for the protection of aquatic life: Nonylphenol and its ethoxylates. Canadian Council of Ministers of the Environment. Winnipeg, Ontario.

36. Zeeman, M. and Gilford, J. 1993. Environmental fate and safety ofnonylphenol ethoxylates. Pp. 7-21. In: Landis W.G.; Hughes, J.S.; and Lewis, M.A. (eds). Environmental Toxicology and Risk Assessment, ASTM STP 1179. American Society for Testing and Materials, Philadelphia, Pennsylvania.

37. Smrchek, J.C. and Zeeman, M.G. 1998. Assessing risks to ecological systems from chemicals. Pp. 24-90. In: Callow, P. (ed).Handbook of Environmental Risk Assessment and Management. Blackwell Science Ltd., Oxford, U.K.

38. Stephan, C.E.; Mount, D.I.; Hansen, D.J.; Gentile, J.H.; Chapman, G.A.; and Brungs, W.A. 1985. Guidelines for deriving numerical national water quality criteria for the protection of aquatic organisms and their uses. Available on-line athttp://www.epa.gov/waterscience/criteria/library/85guidelines.pdf.

39. EPA. 2000. Methods for measuring the toxicity and bioaccumulation of sediment-associated contaminants with freshwater invertebrates. Second Edition. Office of Research and Development and Office of Water. EPA/600/R-99/064.

40. EPA. 1994. Methods for measuring the toxicity of sediment-associated contaminants with estuarine and marine amphipods. Office of Research and Development. EPA/600/R-94/025.

41. EPA. 2001. Methods for assessing the chronic toxicity of marine and estuarine sediment-associated contaminants with the amphipodLeptocheirus plumulosusFirst Edition. Office of Research and Development and Office of Water. EPA/600/R-01/020.

42. Uniform and Textile Service Association (UTSA) and Textile Rental Services Association of America (TRSA) 2007. Letter from Tony Wagner, Director, Environmental and Government Affairs, Uniform and Textile Service Association and Robert Schaeffer, Director, Environmental Affairs, Textile Rental Services Association to Office of Pollution Prevention and Toxics (OPPT), Document Control Office, Re: Comments of the Uniform and Textile Service Association (UTSA) and Textile Rental services Association of America (TRSA) on TSCA Section 21 Petition on Nonylphenol and Nonylphenol Ethoxylates: Docket ID Number EPA-HQ-OPPT-2007-0490. July 25, 2007.

43. EPA. 2007. E-mail communication from Greg Fritz to John Schaeffer and Mary Dominiak. Subject: Vapor Pressure estimates for NP and NPEs (NP1EO and NP2EO) (with two attachments: Huntsman Corporation Technical Bulletin: SURFONIC □ N-31.5 Surfactant (2005) and EPIWIN [SRC CORP.] Program Estimates (EPI_est.doc)). August 14, 2007.

44. Monteiro-Riviere, N.A.; Van Miller, J.P.; Simon, G.; Joiner, R.L.; Brooks, J D.; and Riviere, J.E. 2000. Comparative in vitro dermal absorption of nonylphenol and nonylphenol ethoxylates (NPE-4 and NPE-9) through human, porcine and rate skin.Toxicology and Industrial Health. 16:49-57.

45. EPA. 2007. Draft Engineering Report of Nonylphenol (NP) and Nonylphenol Ethoxylates (NPEs) in Response to Section 21 Petition. EPA, Office of Pollution, Prevention and Toxics, Economics, Exposure and Technology Division, Chemical Engineering Branch. July 18, 2007. 15pp.

46. Occupational Safety and Health Administration (OSHA), Department of Labor. OSHA Chemical Sampling Information: Subtilisins data sheet. September 19, 2007. Naylor, C.G. 1995. Environmental fate and safety of nonylphenol ethoxylates. Available on-line athttp://www.osha.gov/dts/chemicalsampling/data/CH_268300.html.

47. Warburton, J. 2006. Monitoring Individual Exposures to Enzymes in the Workplace.Industrial Hygiene News. May 2006.

48. OECD. 2005. SIDS Report on Linear Alkylbenzene Sulfonates. Section 2.3 Human Exposures. Pp. 24-90. In: SIDS Initial Assessment Report for 20thSIAM. April 2005. United Nations Environment Programme, London, U.K.

49. Radian Corp. 1990. Nonylphenol and nonylphenol ethoxylates in river water and bottom sediments: January 1989-August 1990. Final Report to Alkylphenol and Ethoxylates Panel, Chemical Manufacturers Association.

50. Smrchek, J.; Clements, R.; Morcock, R; and Rabert, W. 1993. Assessing ecological hazard under TSCA: methods and evaluation of data. Pp. 22-39. In: Landis W.G.; Hughes, J.S.; and Lewis, M.A. (eds). Environmental Toxicology and Risk Assessment, ASTM STP 1179. American Society for Testing and Materials, Philadelphia, Pennsylvania.

51. Smrchek, J.; Zeeman, M.; and Clements, R. Ecotoxicology and the assessment ecological of chemicals at the US EPA’s Office of Pollution Prevention and Toxics: current activities and future needs. Pp. 127-158. In: Pratt, J.R.; Bowers, N.; and Stauffer, J.R. (eds). Making Environmental Science, Ecoprint, Portland, OR. 271 pp. 1995.

52. TenEyck, M.C.; and Markee, T.P. 2007. Toxicity of nonylphenol, nonylphenol monoethoxylate, and nonylphenol diethoxylate and mixtures of these compounds toPimephales promelas(fathead minnow) andCeriodaphnia dubia.Archives of Environmental Contamination and Toxicology. 53:599-606.

53. Sun, H. and Gu, X. 2005. Comprehensive toxicity study of nonylpheno and short-chain nonylphenol polyethoxylates onDaphnia magna.Bulletin of Environmental Contamination and Toxicology. 75:677-683.

54. Zeeman, M.; Nabholz, J.V.; and Clements, R.G. 1993. The development of SAR/QSAR for use under EPA’s Toxic Substances Control Act (TSCA): an introduction. Pp. 523-539. In: Gorsuch, J.W.; Dwyer, F.J.; Ingersoll, C.G.; and LaPoint, T.W. (eds). Environmental Toxicology and Risk Assessment-2ndVolume, ASTM STP 1216. American Society for Testing and Materials, Philadelphia, Pennsylvania.

55. Vaal, M.A.; Van Leeuwen, C.J.; Hoekstra, J.A.; and Hermens, J.L. 2000. Variation in sensitivity of aquatic species to toxicants: practical consequences for effect assessment of chemical substances.Environmental Management. 25:415-423.

56. Complaint for Declaratory and Injunctive Relief,Sierra Club et al.v.Johnson, U.S. District Court for the Northern District of California, Case No. C07-05435-MCC, October 24, 2007.

57. Settlement Agreement,Sierra Club et al.v.Johnson, U.S. District Court for the Northern District of California, Case No. C07-05435-MCC, December 30, 2008.

Under Executive Order 12866, entitledRegulatory Planning and Review(58 FR 51735, October 4, 1993), it has been determined that this is a “significant regulatory action” because the initiation of a new rulemaking proceeding may raise novel legal or policy issues. Accordingly, EPA submitted this action to the Office of Management and Budget (OMB) for review under Executive Order 12866 and any changes made in response to OMB recommendations have been documented in the docket for this action.

Because this action does not propose or impose any requirements, other statutory and Executive Order reviews that apply to rulemaking do not apply. Should EPA subsequently determine to pursue a rulemaking, EPA will address the statutes and Executive Orders as applicable to that rulemaking.

Nevertheless, the Agency welcomes comments and/or information that would help the Agency to assess any ofthe following: The potential impact of a rule on small entities pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601et seq.); availability of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note); environmental health or safety effects on children pursuant to Executive Order 13045, entitledProtection of Children from Environmental Health Risks and Safety Risks(62 FR 19985, April 23, 1997); or human health or environmental effects on minority or low-income populations pursuant to Executive Order 12898, entitledFederal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations(59 FR 7629, February 16, 1994). The Agency will consider such comments during the development of any subsequent rulemaking.