Regulatory Actions for Year 2011

With the issuance of this final rule, the Administrator of the Drug Enforcement Administration (DEA) places the substance carisoprodol, including its salts, isomers, and salts of isomers, whenever the existence of such salts, isomers, and salts of isomers is possible, into Schedule IV of the Controlled Substances Act (CSA). This action is pursuant to the CSA which requires that such actions be made on the record after opportunity for a hearing.

NTP Information Cited
DEA used NTP’s Toxicity studies of carisoprodol in rats and mice to support its placement of carisoprodol into Schedule IV of the Controlled Substances Act.

EPA and NHTSA, on behalf of the Department of Transportation, are issuing this joint proposal to further reduce greenhouse gas emissions and improve fuel economy for light-duty vehicles for model years 2017-2025. This proposal extends the National Program beyond the greenhouse gas and corporate average fuel economy standards set for model years 2012-2016. On May 21, 2010, President Obama issued a Presidential Memorandum requesting that NHTSA and EPA develop through notice and comment rulemaking a coordinated National Program to reduce greenhouse gas emissions of light-duty vehicles for model years 2017-2025. This proposal, consistent with the President's request, responds to the country's critical need to address global climate change and to reduce oil consumption. NHTSA is proposing Corporate Average Fuel Economy standards under the Energy Policy and Conservation Act, as amended by the Energy Independence and Security Act, and EPA is proposing greenhouse gas emissions standards under the Clean Air Act. These standards apply to passenger cars, light-duty trucks, and medium-duty passenger vehicles, and represent a continued harmonized and consistent National Program. Under the National Program for model years 2017-2025, automobile manufacturers would be able to continue building a single light-duty national fleet that satisfies all requirements under both programs while ensuring that consumers still have a full range of vehicle choices. EPA is also proposing a minor change to the regulations applicable to MY 2012-2016, with respect to air conditioner performance and measurement of nitrous oxides.

NTP Information Cited
Components of greenhouse gas emissions of light-duty vehicles (benzene, 1,3-butadiene, acetaldehyde, and naphthalene) were cited in the National Toxicology Program’s Report on Carcinogens (ROC). The following compounds have been listed as: a) known carcinogens to humans: Benzene, 1,3-Butadiene; b) possibly carcinogenic to humans; acetaldehyde; or c) reasonably anticipated to be a human carcinogen: naphthalene.

The EPA is proposing amendments to the national emissions standards for hazardous air pollutants for Ferroalloys Production to address the results of the residual risk and technology review that the EPA is required to conduct under the Clean Air Act. These proposed amendments include revisions to particulate matter standards for electric arc furnaces, metal oxygen refining processes, and crushing and screening operations. The amendments also add emission limits for hydrochloric acid, mercury, polycyclic aromatic hydrocarbons, and formaldehyde from electric arc furnaces. Furthermore, the amendments expand and revise the requirements to control fugitive emissions from furnace operations and casting. Other proposed requirements related to testing, monitoring, notification, recordkeeping, and reporting are included. We are also proposing to revise provisions addressing periods of startup, shutdown, and malfunction to ensure that the rules are consistent with a recent court decision.

NTP Information Cited
NTP Work Cited: EPA cited the National Toxicology Program’s Report on Carcinogens (ROC), which states that nickel compounds are known human carcinogens.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS) announces a public meeting to review its approach to classifying carcinogens and establishing recommended exposure limits (RELs) for occupational exposures to hazards associated with cancer. NIOSH requested initial input on these issues (including answers to five questions listed below under SUPPLEMENTARY INFORMATION), to be submitted to NIOSH Docket number 240.

NTP Information Cited
In contrast to the current NIOSH Carcinogen Policy, the National Toxicology Program allows for a more differential classification.

EPA is promulgating this final rule under section 4(a)(1)(B) of the Toxic Substances Control Act (TSCA) to require manufacturers, importers, and processors to conduct testing to obtain screening level data for health and environmental effects and chemical fate for 15 high production volume (HPV) chemical substances listed in this final rule. This test data is needed in order to help EPA to determine whether these 15 HPV chemical substances pose a risk to human health and/or environmental safety. Based on comments received by EPA on the proposed rule for this final rule, EPA has determined that only 15 of the 29 HPV chemical substances proposed for testing meet the criteria for testing at this time.

NTP Information Cited
NTP Work Cited: National Toxicology Program’s Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) developed test method protocols for the uptake of neutral red as a test for cytotoxicity.

EPA is proposing to issue a test rule under Toxic Substances Control Act (TSCA) section 4(a)(1)(B) to require manufacturers and processors of 23 high production volume (HPV) chemical substances to develop screening-level health, environmental, and fate data based on the potential for substantial exposures of workers and consumers to these chemicals. EPA is also proposing to issue simultaneously a significant new use rule (SNUR) for another 22 HPV chemical substances under TSCA section 5(a)(2). The SNUR would require persons to file a significant new use notice (SNUN) with EPA prior to manufacturing, importing, or processing any of these chemical substances for use in a consumer product or for any use, or combination of uses, that is reasonably likely to expose 1,000 or more workers at a single corporate entity. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs. EPA is also soliciting comment on a number of issues with regard to both the test rule and the SNUR.

NTP Information Cited
NTP Work Cited: National Toxicology Program’s Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) developed test method protocols for the uptake of neutral red as a test for cytotoxicity. Standardized protocols are referenced.

In accordance with the Paperwork Reduction Act of 1995, the Forest Service is seeking comments from all interested individuals and organizations on the extension (without revision) of a currently approved information collection, Qualified Products List for Water Enhancers (Gels) for Wildland Firefighting.

NTP Information Cited
The Forest Service evaluates and approves commercial wildland firefighting chemicals. Products must not contain chemicals listed as a Chemical of Concern. To create their list, they include chemicals appearing in the National Toxicology Program’s Report on Carcinogens. (ROC)

In accordance with the Paperwork Reduction Act of 1995, the Forest Service is seeking comments from all interested individuals and organizations on the extension (with contact revision) of a currently approved information collection, Qualified Products List for Long-Term Retardant For Wildland Firefighting.

NTP Information Cited
The Forest Service evaluates and approves commercial wildland firefighting chemicals. Products must not contain chemicals listed as a Chemical of Concern. To create their list, they include chemicals appearing in the National Toxicology Program’s Report on Carcinogens. (ROC)

EPA and NHTSA, on behalf of the Department of Transportation, are each finalizing rules to establish a comprehensive Heavy-Duty National Program that will reduce greenhouse gas emissions and fuel consumption for on-road heavy-duty vehicles, responding to the President's directive on May 21, 2010, to take coordinated steps to produce a new generation of clean vehicles. NHTSA's final fuel consumption standards and EPA's final carbon dioxide (CO2) emissions standards are tailored to each of three regulatory categories of heavy-duty vehicles: Combination Tractors; Heavy-duty Pickup Trucks and Vans; and Vocational Vehicles. The rules include separate standards for the engines that power combination tractors and vocational vehicles. Certain rules are exclusive to the EPA program. These include EPA's final hydrofluorocarbon standards to control leakage from air conditioning systems in combination tractors, and pickup trucks and vans. These also include EPA's final nitrous oxide (N2O) and methane (CH4) emissions standards that apply to all heavy-duty engines, pickup trucks and vans. EPA's final greenhouse gas emission standards under the Clean Air Act will begin with model year 2014. NHTSA's final fuel consumption standards under the Energy Independence and Security Act of 2007 will be voluntary in model years 2014 and 2015, becoming mandatory with model year 2016 for most regulatory categories. Commercial trailers are not regulated in this phase of the Heavy-Duty National Program. The agencies estimate that the combined standards will reduce CO2 emissions by approximately 270 million metric tons and save 530 million barrels of oil over the life of vehicles sold during the 2014 through 2018 model years, providing over $7 billion in net societal benefits, and $49 billion in net societal benefits when private fuel savings are considered. EPA is also finalizing provisions allowing light-duty vehicle manufacturers to use CO2 credits to meet the light-duty vehicle N2O and CH4 standards, technical amendments to the fuel economy provisions for light-duty vehicles, and a technical amendment to the criteria pollutant emissions requirements for certain switch locomotives.

NTP Information Cited
In the National Toxicology Program’s Report on Carcinogens (ROC), the following compounds have been listed as: a) known carcinogens to humans: Benzene, 1,3-Butadiene; b) possibly carcinogenic to humans: acetaldehyde; or c) reasonably anticipated to be a human carcinogen: naphthalene.

EPA and NHTSA, on behalf of the Department of Transportation, are each finalizing rules to establish a comprehensive Heavy-Duty National Program that will reduce greenhouse gas emissions and fuel consumption for on-road heavy-duty vehicles, responding to the President's directive on May 21, 2010, to take coordinated steps to produce a new generation of clean vehicles. NHTSA's final fuel consumption standards and EPA's final carbon dioxide (CO2) emissions standards are tailored to each of three regulatory categories of heavy-duty vehicles: Combination Tractors; Heavy-duty Pickup Trucks and Vans; and Vocational Vehicles. The rules include separate standards for the engines that power combination tractors and vocational vehicles. Certain rules are exclusive to the EPA program. These include EPA's final hydrofluorocarbon standards to control leakage from air conditioning systems in combination tractors, and pickup trucks and vans. These also include EPA's final nitrous oxide (N2O) and methane (CH4) emissions standards that apply to all heavy-duty engines, pickup trucks and vans. EPA's final greenhouse gas emission standards under the Clean Air Act will begin with model year 2014. NHTSA's final fuel consumption standards under the Energy Independence and Security Act of 2007 will be voluntary in model years 2014 and 2015, becoming mandatory with model year 2016 for most regulatory categories. Commercial trailers are not regulated in this phase of the Heavy-Duty National Program. The agencies estimate that the combined standards will reduce CO2 emissions by approximately 270 million metric tons and save 530 million barrels of oil over the life of vehicles sold during the 2014 through 2018 model years, providing over $7 billion in net societal benefits, and $49 billion in net societal benefits when private fuel savings are considered. EPA is also finalizing provisions allowing light-duty vehicle manufacturers to use CO2 credits to meet the light-duty vehicle N2O and CH4 standards, technical amendments to the fuel economy provisions for light-duty vehicles, and a technical amendment to the criteria pollutant emissions requirements for certain switch locomotives.

NTP Information Cited
In the National Toxicology Program’s Report on Carcinogens (ROC), the following compounds have been listed as: a) known carcinogens to humans: Benzene, 1,3-Butadiene; b) possibly carcinogenic to humans: acetaldehyde; or c) reasonably anticipated to be a human carcinogen: naphthalene.

In accordance with the Paperwork Reduction Act of 1995, the Forest Service is seeking comments from all interested individuals and organizations on the extension (without revision) of a currently approved information collection, Qualified Products List for Class A Foams for Wildland Firefighting.

NTP Information Cited
The Forest Service evaluates and approves commercial wildland firefighting chemicals. Products must not contain chemicals listed as a Chemical of Concern. To create their list, they include chemicals appearing in the National Toxicology Program’s Report on Carcinogens. (ROC)

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) intends to review its approach to classifying carcinogens and establishing recommended exposure limits (RELs) for occupational exposures to hazards associated with cancer. As part of this effort, NIOSH is requesting initial input on these issues (including answers to the 5 questions in the following section), to be submitted to the NIOSH Docket number 240, for a comment period lasting through September 22, 2011. This information will be taken under consideration and used to inform NIOSH efforts to assess and document its carcinogen policy and REL policy regarding occupational hazards associated with cancer.

NTP Information Cited
The National Toxicology Program's carcinogen classification allows for a more differential categorization than NIOSH's definition.

The Food and Drug Administration (FDA) is requesting comments, including scientific and other information, concerning the harmful and potentially harmful constituents (HPHCs) in tobacco products and tobacco smoke. This information will assist the Agency in establishing a list of HPHCs in tobacco products and tobacco smoke (the HPHC list).

NTP Information Cited
National Toxicology Program has identified constituents in tobacco products and tobacco smoke as human carcinogens or reasonably anticipated to be human carcinogens. (ROC)

This regulation establishes an exemption from the requirement of a tolerance for residues of carboxymethyl guar gum sodium salt (CAS Reg. No. 39346-76-4) and carboxy­methyl-hydroxy­propyl guar (CAS Reg. No. 68130-15-4); when used as an inert ingredient (thicker/drift reduction agent) in pesticide formulations applied to growing crops. SciReg Inc., on behalf of Rhodia Inc., submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of carboxymethyl guar gum sodium salt and carboxy­methyl-hydroxy­propyl guar.

NTP Information Cited
In carcinogenicity studies in mice and rats, no adverse effects were observed. (TR-229)

Bisphenol A (BPA) (Chemical Abstracts Service Registry Number (CASRN) 80-05-7), a high production volume (HPV) chemical, is a reproductive, developmental, and systemic toxicant in animal studies and is weakly estrogenic. EPA is providing this ANPRM to request comment on requiring toxicity testing to determine the potential for BPA to cause adverse effects, including endocrine-related effects, in environmental organisms at low concentrations. EPA is also seeking comment on requiring environmental testing consisting of sampling and monitoring for BPA in surface water, ground water, drinking water, soil, sediment, sludge, and landfill leachate in the vicinity of expected BPA releases to determine whether environmental organisms may currently be exposed to concentrations of BPA in the environment that are at or above levels of concern for adverse effects, including endocrine-related effects. This ANPRM is directed only toward the environmental presence and environmental effects of BPA. EPA is working with the Department of Health and Human Services (HHS) on potential human health issues, but is not considering any additional testing specifically in regard to human health issues at this time.

NTP Information Cited
BPA is a reproductive and developmental toxicant. Studies show reduced fetal or birth weight or growth early in life, effects on testis of male rats, possible decreased fertility in mice, altered estrous cycling in female rats, and reduced survival of fetuses. There are also reports of endocrine-related low-dose effects on puberty and neurological development. (Monograph on Bisphenol A)

PHMSA amends the Hazardous Materials Regulations by removing saccharin and its salts from the list of hazardous substances and reportable quantities. The Comprehensive Environmental Response, Compensation and Liability Act, requires PHMSA to list and regulate all hazardous substances designated by statute or by the U.S. Environmental Protection Agency (EPA). EPA recently removed saccharin and its salts from their list of hazardous substances through notice and comment rulemaking. This final rule simply harmonizes the lists to better enable shippers and carriers to identify the affected hazardous substances, comply with all applicable regulatory requirements, and make required notifications if the release of a hazardous substance occurs.

NTP Information Cited
Saccharin and its salts do not pose a present or potential risk of causing carcinogenic effects on humans. (ROC, Appendix B)

This regulation establishes an exemption from the requirement of a tolerance for residues of Diethylene Glycol MonoEthyl Ether (DEGEE) when used as an inert ingredient as a solvent, stabilizer and/or antifreeze within pesticide formulations/products, for preharvest use on growing crops and raw agricultural commodities, without limitation. Huntsman, Dow AgroSciences L.L.C., Nufarm Americas Inc., BASF, Stepan Company, Loveland Products Inc., and Rhodia Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of DEGEE on growing crops and raw agricultural commodities.

NTP Information Cited
Ethylene glycol, which is structurally similar to DEGEE, does not cause carcinogenicity in mice. (TR-413)

The Food and Drug Administration (FDA) is issuing this document to address labeling and effectiveness testing for certain over-the-counter (OTC) sunscreen products containing specified active ingredients and marketed without approved applications. This document addresses labeling and effectiveness testing issues raised by the nearly 2,900 submissions that we received in response to the sunscreen proposed rule of August 27, 2007 (2007 proposed rule). The document also identifies specific claims that render a product that is subject to this rule misbranded or would not be allowed on any OTC sunscreen product marketed without an approved application. The document does not address issues related to sunscreen active ingredients or certain other issues regarding the GRASE determination for sunscreen products. The document requires OTC sunscreen products to comply with the content and format requirements for OTC drug labeling contained in the 1999 Drug Facts final rule (published in the Federal Register of March 17, 1999, by lifting the delay of implementation date for that rule that we published on September 3, 2004).

NTP Information Cited
The Report on Carcinogens indicates that UVA and UVB radiation across the spectrum are known human carcinogens, but either UVA or UVB radiation alone is reasonably anticipated to be a human carcinogen. Cited in the National Toxicology Program’s Report on Carcinogens. (ROC)

This regulation establishes an exemption from the requirement of a tolerance for residues of ethylene glycol (CAS Reg. No. 107-21-1) when used as a pesticide inert ingredient as a solvent, stabilizer and/or antifreeze within pesticide formulations/products without limitation. Huntsman, et. al, submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of ethylene glycol. Also, this regulation establishes an exemption from the requirement of a tolerance for residues of ethylene glycol (CAS Reg. No. 107-21-1) when used as an inert ingredient as an encapsulating agent for pesticides being applied post-harvest as residual, and crack and crevice sprays in and around food and nonfood areas of residential and nonresidential structures, including food handling establishments, with no limit. The Sumitomo Chemical Company submitted a petition to EPA under FFDCA, requesting an establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of ethylene glycol.

NTP Information Cited
Based on the lack of mutagenicity and lack of carcinogenicity in rodents, ethylene glycol is not expected to pose a carcinogenic risk in humans. (TR-26)

In compliance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), this document announces that an Information Collection Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval. This is a request to make changes to and renew an existing approved collection. The ICR Supporting Statement, which is abstracted below, describes the nature of the information collection (including proposed minor form revisions) and its estimated burden and cost.

NTP Information Cited
Addition of National Toxicology Program Carcinogens rule is estimated to increase the number of reporting facilities by 74 and the number of Form Rs submitted by 186 with an associated burden increase of 6,641 hours.

DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement the requirements for minimizing the use of materials containing hexavalent chromium in items acquired by DoD (deliverables and construction materials hereafter referred to as deliverables). Hexavalent chromium is a chemical that has been used in numerous DoD weapons systems and platforms due to its corrosion protection properties. However, hexavalent chromium is a known carcinogen. This rule codifies a DoD policy for addressing the serious human health and environmental risks related to the use of hexavalent chromium. The rule prohibits the delivery of items containing more than 0.1 percent by weight hexavalent chromium in any homogeneous material under DoD contracts unless there is no acceptable alternative to the use of hexavalent chromium.

NTP Information Cited
The National Toxicology Program’s Report on Carcinogens lists hexavalent chromium compounds as known human carcinogens. (ROC)

The Office of Environmental Health Hazard Assessment (OEHHA) within the California Environmental Protection Agency is adding four chemicals -- androstenedione (CAS No. 63-05-8), dibromoacetonitrile (CAS No. 3252-43-5), hexachlorobutadiene (CAS No. 87-68-3), and malonaldehyde, sodium salt (CAS No. 24382-04-5) -- to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 ). The listing of the four chemicals is effective May 3, 2011.

NTP Information Cited
National Toxicology Program (NTP, 1988). Toxicology and Carcinogenesis Studies of Malonaldehyde, Sodium Salt (3-Hydroxy-2-propenal, Sodium Salt) (CAS No. 24382-04-5) in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 331. NIH Publication No. 89-2587, U.S. Department of Health and Human Services, NTP Research Triangle Park, NC.

The Office of Environmental Health Hazard Assessment (OEHHA) within the California Environmental Protection Agency is adding four chemicals -- androstenedione (CAS No. 63-05-8), dibromoacetonitrile (CAS No. 3252-43-5), hexachlorobutadiene (CAS No. 87-68-3), and malonaldehyde, sodium salt (CAS No. 24382-04-5) -- to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 ). The listing of the four chemicals is effective May 3, 2011.

NTP Information Cited
National Toxicology Program (NTP, 2010). Toxicology and Carcinogenesis Studies of Androstenedione (CAS No. 63-05-8) in F344/N Rats and B6C3F1 Mice (Gavage Studies). NTP Technical Report Series No. 560. NIH Publication No. 10-5901. U.S. Department of Health and Human Services, NTP, Research Triangle Park, NC.

The Office of Environmental Health Hazard Assessment (OEHHA) within the California Environmental Protection Agency is adding four chemicals -- androstenedione (CAS No. 63-05-8), dibromoacetonitrile (CAS No. 3252-43-5), hexachlorobutadiene (CAS No. 87-68-3), and malonaldehyde, sodium salt (CAS No. 24382-04-5) -- to the list of chemicals known to the state to cause cancer for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 ). The listing of the four chemicals is effective May 3, 2011.

NTP Information Cited
National Toxicology Program (NTP, 2010). Toxicology and Carcinogenesis Studies of Dibromoacetonitrile (CAS No. 3252-43-5) in F344/N Rats and B6C3F1 Mice (Drinking Water Studies). NTP Technical Report Series No. 544. NIH Publication No. 10-5886. U.S. Department of Health and Human Services, NTP, Research Triangle Park, NC.

The United States (U.S.) Environmental Protection Agency (EPA or Agency) is proposing national emission standards for hazardous air pollutants (NESHAP) from coal- and oil-fired electric utility steam generating units (EGUs) under Clean Air Act (CAA or the Act) section 112(d) and proposing revised new source performance standards (NSPS) for fossil-fuel-fired EGUs under CAA section 111(b). The proposed NESHAP would protect air quality and promote public health by reducing emissions of the hazardous air pollutants (HAP) listed in CAA section 112(b). In addition, these proposed amendments to the NSPS are in response to a voluntary remand of a final rule. We also are proposing several minor amendments, technical clarifications, and corrections to existing NSPS provisions for fossil-fuel-fired EGUs and large and small industrial-commercial-institutional steam generating units.

NTP Information Cited
Acetaldehyde is reasonably anticipated to be a human carcinogen. Benzene is characterized as a known human carcinogen. Both are cited in the National Toxicology Program’s Report on Carcinogens. (ROC)

EPA is announcing a 60-day public comment period and listening session for the external review draft human health assessment titled, ‘‘Toxicological Review of Methanol (Non-Cancer): In Support of Summary Information on the Integrated Risk Information System (IRIS)’’ (EPA/635/R–11/001). The draft assessment was prepared by the National Center for Environmental Assessment (NCEA) within the EPA Office of Research and Development (ORD). EPA is releasing this draft assessment solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. This draft assessment has not been formally disseminated by EPA. It does not represent and should not be construed to represent any Agency policy or determination.

NTP Information Cited
A National Toxicology Program report recommended performing pathology reviews to resolve differences of opinion in the diagnoses of certain tumors reported in a Ramazzini Institute methanol research study. This study was cited and used to support some of the conclusions in the draft IRIS Methanol Toxicological Review. Following the report from the National Toxicology Program, EPA placed the external peer review of the draft IRIS Methanol Toxicological Review on hold. (IRIS)

This regulation establishes an exemption from the requirement of a tolerance for residues of sodium ferric ethylenediaminetetraacetate (EDTA) in or on all food commodities when applied as a molluscicide and used in accordance with good agricultural practices. W. Neudorff GmbH KG submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of sodium ferric EDTA under the FFDCA.

NTP Information Cited
National Toxicology Program (NTP); Technical Report Series No. 11. (TR-11)

The Office of Environmental Health Hazard Assessment (OEHHA) within the California Environmental Protection Agency is adding acrylamide (CAS No. 79-06-1) to the list of chemicals known to the state to cause reproductive toxicity for purposes of the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). The listing of acrylamide is effective February 25, 2011. Acrylamide is being listed as a chemical known to the State of California to cause developmental and male reproductive toxicity.

NTP Information Cited
NTP-CERHR. NTP-CERHR Monograph on the Potential Human Reproductive and Developmental Effects of Acrylamide. NIH Publication No. 05-4472. (2005)

In compliance with the Paperwork Reduction Act (PRA)(44 U.S.C. 3501 et seq.), EPA is planning to submit a request to renew an existing approved Information Collection Request (ICR) to the Office of Management and Budget (OMB). This ICR is scheduled to expire on July 31, 2011. The ICR Supporting Statement, which is summarized below and also posted in the docket, along with a technical document titled ‘‘Revising TRI Burden to Ratio-Based Methodology,’’ describes the nature of the information collection (including proposed form changes) and its estimated burden and cost. Before submitting the ICR to OMB for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection as described below.

NTP Information Cited
On November 26, 2010, the Addition of National Toxicology Program Carcinogens rule was published in the Federal Register.

The addition of National Toxicology Program Carcinogens rule, affects the EPA’s Information ColIection Request (ICR) by increasing the number of reporting facilities by 74 and the number of Form Rs submitted by 186 with an associated burden increase of 6,641 hours.

This regulation establishes an exemption from the requirement of a tolerance for residues of (S,S)-Ethylene­diamine Di­succinic Acid Tri­sodium Salt (CAS Reg. No. 178949–82–1) when used as an inert ingredient (sequestrant or chelating agent) in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest under EPA regulations. Innospec Limited submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of (S,S)-ethylenediamine disuccinic acid trisodium salt.

NTP Information Cited
NTP tested trisodium ethylenediaminetetraacetate trihydrate (EDTA)in mice and rats and it showed no carcinogenic potential. Since (S,S)-Ethylene­diamine Di­succinic Acid Tri­sodium Salt is similar to EDTA, (S,S)-EDDS is not likely to be carcinogenic to humans at low doses. (TR-11) (TS)

4-Methylimidazole meets the criteria for listing as known to the State to cause cancer under the Safe Drinking Water and Toxic Enforcement Act of 1986 (Health and Safety Code Section 25249.5 et seq.), more commonly known as Proposition 65, via the authoritative bodies mechanism. The regulatory requirements for listing by this mechanism are set forth in Title

NTP Information Cited
National Toxicology Program (NTP, 2007). Toxicology and Carcinogenesis Studies of 4-Methylimidazole (CAS No. 822-36-6) in F344/N Rats and B6C3F1 Mice (Feed Studies). NTP Technical Report Series No. 535. NIH Publication No. 07-4471. U.S. Department of Health and Human Services, NTP, Research Triangle Park, NC.