EPA updates Endocrine Disruptor Screening Program plan.

Today, the EPA announced the update of its Endocrine Disruptor Screening Program (EDSP) Comprehensive Management Plan. The EDSP was established by EPA in 1998 under the authority of 1996 amendments to the Federal Food, Drug and Cosmetic Act and Safe Drinking Water Act with the mission to screen chemicals in pesticides, commercial chemicals, and environmental contaminants for potential adverse effects on estrogen, androgen, and thyroid hormone systems. Generally, the EDSP provides for a two-tiered screening and testing program based on prioritized lists of chemicals.

The updated plan [PDF] outlines the critical activities for the program over the next five years, as well as strategic guidance for the agency. According to the EPA’s announcement email, a focus of the program’s activities will be “using informational technology to enhance data interpretation and applying computational methods to more efficiently prioritize and screen the universe of EDSP chemicals for potential effects on the endocrine system.”

The EDSP plan – which is non-binding – applies to fiscal year 2014 through fiscal year 2019, and will be evaluated on an annual basis for revisions. In fiscal year 2013, the program underwent four external scientific peer reviews on the critical science of the program; EPA will be considering the recommendations made by the reviewers in revising the plan moving forward, while undergoing further reviews on computational models and methods in the next few years. Other activities planned in 2014 include:

  • Completion of List 1, Tier 1 scientific review, data evaluation records, and weight of evidence decisions for 52 pesticide chemicals;
  • Completion of Tier 2 Test Methods Validation, development of test guidelines, guidance documents and standard evaluation procedures;
  • Issuance of List 1 Chemicals, Tier 2 test orders and review of other scientifically relevant information;
  • Develop various IT solutions to increase efficiency through electronic submission, tracking, and systematic data reviews; and
  • Issuance of List 2 Chemicals, Tier 1 test orders and review of other scientifically relevant information; test orders will be issued incrementally over three years.

The plan envisions completing all testing and scientific reviews, data evaluation records, and weight of evidence decisions by 2021-2023. More information on the EDSP is available on the program’s website.

U.S. retailer Target introduces sustainable product standard.

On October 7, 2013, Target announced a new Sustainable Product Standard that it will begin using this month to evaluate the sustainability and environmental impact of products sold in its stores.

Target said that it will ask “vendors representing 7,500 products in household cleaners, personal care and beauty and baby care” to provide product ingredients and information about various environmental attributes so that the company can assess products using GoodGuide’s UL Transparency Platform, a business-to-business screening tool that allows a company to evaluate ingredient information provided by suppliers. The Platform’s assessment tool will compare the product data to hazard trait and regulatory and other environmental criteria lists.

After being evaluated, each product will be assigned up to 100 points based on the sustainability of ingredients, ingredient transparency and overall environmental impact. Target’s announcement explains that the standard was developed “over the last two years in partnership with industry experts, vendors and NGOs.” The standard “will help establish a common language and definition for qualifying what makes a product more sustainable.”

According to Target spokesperson Jessica Stevens, the Sustainable Product Standard “does not have a direct guest-facing, in-store component,” so consumers will not see product assessment scores displayed in stores. Stevens explained that “products that pass a minimum threshold to be set by Target” will have access to special merchandising and marketing support.

Many environmental advocates like the Campaign for Safe Cosmetics and Breast Cancer Fund and Campaign for Safe Cosmetics were enthusiastic about the new standard. However, BizNGO chair and Clean Production Action co-director Mark Rossi expressed concern that the UL Transparency Platform is designed for information sharing between businesses and does not require any public disclosure; the platform’s proprietary nature means consumers and safety advocates have no access to the criteria used in its assessments. Although Target has not released any details on its scoring or standard benchmarks, it is expected to do so in the near future.

Target’s new Sustainable Product Standard follows its competitor Walmart’s announcement of its own “Policy on Sustainable Chemistry in Consumables,” which we discussed last month. Walmart’s policy is based on GreenWERCS, its own proprietary tool that assesses products’ chemical composition and screens for potential adverse human and environmental effects. Both retailers are taking steps to increase transparency and eliminate potentially hazardous chemical ingredients in their supply chains, although Target’s policy focuses on incentivizing safer products through its point-based standard, while Walmart’s approach is to eliminate certain chemical ingredients from products in their stores altogether.

EPA Budget Would Increase Spending on Chemical Assessment and Control

EPA Budget/Chemical Control

According to an EPA press release, today the Obama Administration proposed a FY 2013 budget of $8.344 billion for the agency. The budget is $105 million below the EPA’s enacted level for FY 2012, but it increases spending by $11 million, or approximately 16%, to “protect … Americans from harmful chemicals.”  This increase for chemical assessment and control signals a clear intention to promote regulatory TSCA reform and related efforts in the absence of legislative reform. 

The press release states – “EPA is proposing $68 million, an increase of $11 million from FY 2012, to reduce chemical risks, increase the pace of chemical hazard assessments, and provide the public with greater access to toxic chemical information. Funding will sustain the agency’s successes in managing the potential risks of new chemicals coming into the market and accelerating the progress to help ensure the safety of chemicals on the market that have not been tested for adverse human health and environmental impacts.”

A complete copy of the agency’s budget proposal is available here.

EPA Assistant Administrator Steve Owens Resigns

EPA Administration/Chemical Regulation:

On Tuesday, October 25, 2011, the Environmental Protection Agency (EPA) announced the resignation of Assistant Administrator Steve Owens.  Readers will recall that President Obama appointed Mr. Owens the Assistant Administrator for the Office of Chemical Safety and Pollution Prevention (OCSPP), which is the office implementing the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Pollution Prevention Act, and other federal laws concerning chemicals management.  November 30, 2011, will be Mr. Owens’ last day in office before returning home to Arizona where he previously served as the Director of the Arizona Department of Environmental Quality.  It is unclear at this time who will assume Mr. Owen’s responsibilities and what effect his departure will have on EPA’s various chemicals management initiatives.

Mr. Owens served the EPA during a two-year period in which Congress, the courts, and various stakeholders engaged in vigorous debate and litigation over the appropriate regulation of chemicals in the United States.  In a 2010 brown-bag session (available on podcast), sponsored by the American Bar Association’s Pesticides, Chemical Regulation, and Right-to-Know Committee, Mr. Owens discussed many of the initiatives the Agency was undertaking and some of the challenges it faced as it participated and attempted to shape the debate. 

In a letter to EPA staff announcing his resignation, Mr. Owens said:

“I am writing to tell you that, after more than two years of working closely with all of you to protect Americans’ health and environment, I have made the difficult decision to leave EPA. My last day in the office will be November 30, 2011.
 
As many of you know, my family has remained in Arizona while I have been working at EPA headquarters in Washington. Although I have been able to get home to see my family periodically, I have essentially been away from them for more than two years. After a lot of hard thinking, we have decided that it is time for me to come home. My wife needs her husband; my sons need their father; and I need them.
 
While I am very happy that I will be back with my family, I will miss all of you greatly. It has been a true privilege to work with so many incredibly talented and dedicated people who are doing so much to protect the health and safety of the American people and our environment.
 
I am extremely grateful to Lisa Jackson for her wonderful friendship and the remarkable vision and leadership she provides to this Agency. We are truly fortunate that she is EPA’s Administrator.
 
As I said earlier, I will continue working alongside you all through November 30. Administrator Jackson will share additional information about the transition process shortly.
 
In closing, let me thank you so much for the friendship and support you have given me during my time at EPA. Please know how much I appreciate you and all that you are doing for our country.”

 

EPA Issues Testing Rules and a Significant New Use Rule for HPV Chemicals

TSCA/HPV Chemical Testing:

On October 21, 2011, utilizing its authority under the Toxic Substances Control Act (TSCA), 15 U.S.C. §2601 et seq., EPA published two Federal Register notices announcing testing rules for certain high production volume (HPV) chemicals as well as significant new use rules (SNURs) for other HPV chemicals.  HPV chemicals are those with a production/import volume equal to or greater than 1 million pounds (lbs) per year.  The first notice promulgates a final testing rule for 15 HPV chemicals.  The second notice adopts an innovative approach to regulating HPV chemicals, proposing a testing rule for 23 HPV chemicals and a SNUR for 22 others, along with an alternative proposal to regulate any of the 23 chemicals via a SNUR should public comments indicate a testing rule is unecessary.  Additional details about the rules and the affected chemicals are provided below.

Final Test Rule

The first notice promulgates a final rule under section 4(a)(1)(B) that requires manufacturers, importers, and processors to conduct testing to obtain screening level data for health and environmental effects and chemical fate for 15 HPV chemicals.  (As a general matter, only certain manufacturers/importers actually perform testing required under section 4.)  The chemicals are part of the so-called “Third Group of Unsponsored HPV Chemicals (HPV3),” a group of 29 chemicals for which no manufacturer or importer accepted the “challenge” to make publicly available health and environmental effects data under the voluntary High Production Volume Challenge Program launched in 1998.  The rule will be effective on November 21, 2011.

According to EPA, there are insufficient data to reasonably determine or predict the effects on human health or the environment from the manufacture, distribution in commerce, processing, use, or disposal of these chemicals, or from any combination of these activities.  Thus, the Agency concluded that testing is needed.  Data developed under this final rule supposedly will provide EPA with critical information about the environmental fate and potential hazards associated with these chemicals which, when combined with information about exposure and uses, will allow the Agency and others to evaluate potential health and environmental risks and to take appropriate action.

EPA’s action affects more persons than those who are required to perform testing.  Persons who export or intend to export any of the chemicals in any form (e.g., as byproducts, impurities, components of Class 2 chemical substances, etc.) included in the final rule would be subject to the export notification requirements in TSCA section 12(b)(1) and at 40 CFR part 707, subpart D.  Export notification is generally not required for articles, as provided by 40 CFR 707.60(b).  Section 12(b) of TSCA states, in part, that any person who exports or intends to export to a foreign country a chemical for which the submission of data is required under TSCA section 4 must notify EPA of such export or intent to export.  EPA in turn will notify the government of the importing country of the Agency’s regulatory action with respect to the chemical.

The following chemicals are the subject of this final rule:

CAS

Number

Name

98-09-9

Benzenesulfonyl chloride

98-56-6

Benzene, 1-chloro-4-(trifluoromethyl)-

111-44-4

Ethane, 1,1′-oxybis[2-chloro-.

127-68-4

Benzenesulfonic acid, 3-nitro-, sodium salt (1:1)

515-40-2

Benzene, (2-chloro-1,1-dimethylethyl)-

2494-89-5

Ethanol, 2-[(4-aminophenyl)sulfonyl]-, 1-(hydrogen sulfate)

5026-74-4

2-Oxiranemethanamine, N-[4-(2-oxiranylmethoxy)phenyl]-N-(2-oxiranylmethyl)-

22527-63-5

Propanoic acid, 2-methyl-, 3-(benzoyloxy)-2,2,4-trimethylpentyl ester

25321-41-9

Benzenesulfonic acid, dimethyl-

52556-42-0

1-Propanesulfonic acid, 2-hydroxy-3-(2-propen-1-yloxy)-, sodium salt (1:1)

68082-78-0

Lard, oil, Me esters

68442-60-4

Acetaldehyde, reaction products with formaldehyde, by-products from

68610-90-2

2-Butenedioic acid (2E)-, di-C8-18-alkyl esters

70693-50-4

Phenol, 2,4-bis(1-methyl-1-phenylethyl)-6-[2-(2-nitrophenyl)diazenyl]-

72162-15-3

1-Decene, sulfurized

Proposed Test Rule and SNUR

The proposed test rule, adopted pursuant to section 4(a)(1)(B) of TSCA, would require manufacturers, importers, and processors of 23 HPV chemicals to develop screening-level health, environmental, and fate data, based on the potential for substantial exposures of workers and consumers to these chemicals. The proposed significant new use rule (SNUR), adopted pursuant to section 5(a)(2), would require persons to file a “significant new use” notice (SNUN) with EPA prior to manufacturing, importing, or processing any of a separate group of 22 chemicals for (1) use in a consumer product or (2) for any use, or combination of uses, that is reasonably likely to expose 1,000 or more workers at a single corporate entity.  The chemicals are part of the so-called “Fourth Group of Unsponsored HPV Chemicals (HPV4).”  Public comments are due by January 19, 2012.

EPA’s use of two rules is an innovative approach to regulating this group of 45 HPV chemicals.  If successful, the Agency may use the same approach to regulating future HPV chemicals (i.e., those designated HPV in in 2012 and beyond).  According to EPA, it is proposing the two actions together because the Agency believes they are complementary and will best ensure these HPV chemicals are adequately evaluated.  For example, if EPA receives comments on this proposal sufficient to establish that one of the 23 chemicals proposed for testing is not used in a way that meets the substantial exposure criteria in section 4(a)(1)(B), but information received indicates that the chemical meets the criteria for the SNUR, EPA intends to include the chemical in the final SNUR rather than the test rule, without further public notice and comment.  According to the Agency, simply removing such a chemical from the test rule, without including it in the SNUR, would not provide a regulatory mechanism for timely notification to EPA in the event of changed circumstances that would likely justify the issuance of a test rule for the chemical.  EPA also states that, if public comment on these proposed actions is sufficient to establish that any of the uses to be covered for the 22 chemical substances proposed in the SNUR are, in fact, on-going, yet such comments also establish that there is already substantial exposure to the chemical substance, EPA intends to review the status of the chemical and, as warranted, take appropriate steps to promulgate a test rule rather than a SNUR for the chemical.

The 23 chemicals subject to the test rule, and for which the SNUR is an option, are the following:

CAS Number

Name

56-40-6

Glycine

67-72-1

Ethane, 1,1,1,2,2,2-hexachloro-

78-00-2

Plumbane, tetraethyl-

95-14-7

1H-Benzotriazole

118-48-9

2H-3,1-Benzoxazine-2,4(1H)-dione

128-44-9

1,2-Benzisothiazol-3(2H)-one, 1,1-dioxide, sodium salt (1:1)

928-72-3

Glycine, N-(carboxymethyl)-, sodium salt (1:2)

1809-19-4

Phosphonic acid, dibutyl ester

25377-73-5

2,5-Furandione, 3-(dodecen-1-yl)dihydro-

26544-38-7

2,5-Furandione, dihydro-3-(tetrapropenyl)-

27859-58-1

Butanedioic acid,2-(tetrapropenyl)-

28777-98-2

2,5-Furandione, dihydro-3-(octadecen-1-yl)-

29385-43-1

1H-Benzotriazole, 6(or75)-methyl-.

32072-96-1

2,5-Furandione, 3-(hexadecen-1-yl)dihydro-

61789-73-9

Quaternary ammonium compounds, benzylbis(hydrogenated tallow alkyl)methyl, chlorides

64665-57-2

1H-Benzotriazole, 6(or7)-methyl-, sodium salt

68131-13-5

Naphthenic acids, reaction products with diethylenetriamine

68153-60-6

Fatty acids, tall-oil, reaction products with diethylenetriamine, acetates

68424-85-1

Quaternary ammonium compounds, benzyl-C12-16-alkyldimethyl, chlorides

68442-77-3

2-Butenediamide, (2E)-, N1,N4-bis[2-(4,5-dihydro-2-nortall-oil alkyl-1H-imidazol-1-yl)ethyl] derivs.

68607-28-3

Quaternary ammonium compounds, (oxydi-2,1-ethanediyl)bis[coco alkyldimethyl, dichlorides

68909-18-2

Pyridinium, 1-(phenylmethyl)-, Et Me derivs., chlorides

69834-17-9

Benzene, decylphenoxy-

The 22 chemicals subject to the SNUR, and for which a future test rule is an option, are the following:

CAS Number

Name

98-16-8

Benzenamine, 3-(trifluoromethyl)-

100-53-8

Benzenemethanethiol

104-91-6

Phenol, 4-nitroso-

110-03-2

2,5-Hexanediol, 2,5-dimethyl-

124-63-0

Methanesulfonyl chloride

142-30-3

3-Hexyne-2,5-diol, 2,5-dimethyl-

460-00-4

Benzene, 1-bromo-4-fluoro-

542-92-7

1,3-Cyclopentadiene

553-26-4

4,4′-Bipyridine

8007-45-2

Tar, coal

28106-30-1

Benzene, ethenylethyl-

35203-06-6

Benzenamine, 2-ethyl-6-methyl-N-methylene-

35203-08-8

Benzenamine, 2,6-diethyl-N-methylene-

37734-45-5

Carbonochloridothioic acid, S-(phenylmethyl) ester

37764-25-3

Acetamide, 2,2-dichloro-N,N-di-2-propen-1-yl-

61789-72-8

Quaternary ammonium compounds, benzyl(hydrogenated tallow alkyl)dimethyl, chlorides

61790-13-4

Naphthenic acids, sodium salts

65996-91-0

Distillates (coal tar), upper

68308-01-0

Tail gas (petroleum), cracked distillate hydrotreater stripper

68478-20-6

Residues (petroleum), steam-cracked petroleum distillates cyclopentadiene conc., C4-cyclopentadiene-free.

68526-82-9

Alkenes, C6-10, hydroformylation products, highboiling

68909-77-3

Ethanol, 2,2′-oxybis-, reaction products with ammonia, morpholine derivs. Residues

Similar to the final rule discussed above, EPA’s action affects more persons than those who are required to perform testing or submit SNUNs.  Once the rule became final, exporters of the chemicals subject to the final test rule would be subject to the export notification requirements in section 12(b).  However, exporters of chemicals subject to the proposed SNUR became subject to those requirements upon publication of this proposed rule.

****

Readers interested in following EPA’s innovative approach to regulating HPV should look for future posts on this topic, here at the Green Chemistry Law Report.

EPA to Identify Priority Chemicals for Review

Readers interested in EPA chemical risk management efforts may be interested in the Agency’s new initiative to identify priority chemicals for review and possible risk management action under TSCA. This initiative is part Agency efforts to enhance its chemical management program.  The Office of Pollution Prevention and Toxics notes that strengthening EPA’s chemicals management and risk assessment program is an Agency priority. Goals for the chemical prioritization initiative include identification of highest priority chemicals, determination of whether risk is significant, and whether risk management or other action under TSCA is warranted. The Agency plans to release an initial list of priority chemicals by late fall.

To identify candidate chemicals for review, EPA will consider risk-based prioritization factors similar to those used for selecting chemicals on which EPA has recently prepared Chemical Action Plans. Children’s health issues, PBT chemicals, and carcinogens are among the Agency’s highest hazard-based priorities.

The Agency has specifically solicited public input on which prioritization factors should receive greatest consideration. Following this data collection, EPA will refine the list of priority chemicals for review using a broader range of data sources. It has also requested comments on which data sources the Agency should consider to help identify priority chemicals. Potential data sources for both exposure and use-related information and hazard data sources are listed in the Discussion Guide for Identifying Priority Chemicals for Review and Assessment (available here). A web-based discussion forum is available for submitting suggestions. Submissions will be accepted only until 5:00 PM Eastern Daylight Time on September 14, 2011. At a later date this information will also be available in docket, EPA-HQ-OPPT-2011-0516, at http://www.regulations.gov.

EPA stresses that decisions about whether or not a chemical presents a risk to human health or the environment will be made only after review and assessment efforts are completed. That is, identification of a chemical as a priority chemical for review is not an Agency “finding” under TSCA.

The Agency anticipates that the chemicals identified as priority chemicals for review will likely be well-characterized for hazard and have information indicating exposure potential. The discussion guide notes that EPA will continue to use its TSCA information collection, testing, and subpoena authorities, including sections 4, 8, and 11(c) of TSCA, to develop needed information on additional chemicals that currently have less robust hazard or exposure databases.

A webinar describing this effort was conducted September 7, 2001. The slides presented during that program are available here.

More Information on EPA’s efforts to Identify Priority Chemicals for Review available here.

General information on EPA’s Enhancing EPA’s Chemical Management Program available here.

Information on EPA Development of Chemical Action Plans available here.

EPA Awards Contracts to U.S. Companies to Screen Chemicals for Human Health Impacts

Chemical Screening:

EPA continues in its laudable quest to screen thousands of chemicals.  See press release below.

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EPA Awards Contracts to U.S. Companies to Screen Chemicals for Human Health Impacts

WASHINGTON— The U.S. Environmental Protection Agency’s (EPA) ToxCast chemical screening program has awarded contracts to four United States-based companies to test up to 10,000 chemicals for potential toxicity to people and the environment. ToxCast is designed to determine how chemical exposures affect human health.  When fully implemented, ToxCast will be able to screen thousands of chemicals in fast, cost-effective tests.

The four companies will initially screen up to 1,000 chemicals currently in the ToxCast program using innovative technologies such as stem cell toxicity tests. These new technologies can quickly determine the potential for a chemical to cause harm to the human body.  Screening results from the new technologies will be combined with data already being generated by the other 500 rapid chemical tests used by EPA’s ToxCast program.

The chemicals ToxCast is now screening are found in industrial and consumer products, food additives and drugs. ToxCast’s goal is to reduce EPA’s reliance on slow and expensive animal toxicity tests, enabling the agency to screen chemicals more quickly and to predict and identify potential risks to Americans.

EPA scientific studies using ToxCast have already been published in peer-reviewed science journals, and demonstrate the ability of ToxCast to predict a chemical’s potential to cause several diseases.

The four companies awarded the contracts have offices throughout the country and plan to hire new scientific staff to help with the project. The companies are Vala Sciences, Cee Tox, CellzDirect and BioReliance.  Two of the companies, Vala Sciences and BioReliance are small businesses based in San Diego, Calif. and Kalamazoo, Mich. All four companies plan to hire new employees as a result of these contracts.

More information on ToxCast:  http://epa.gov/ncct/toxcast/

More information on ToxCast database:  http://actor.epa.gov/actor/faces/ToxCastDB/Home.jsp

 

EPA's Chemical Screening Gets a Big Boost – From a Robot!

Chemical Screening:

On March 10, 2011, the U.S. Environmental Protection Agency (EPA) officially launched a robust new tool for screening chemicals for health and environmental hazards.  It’s a robot called the Tox21 Robotic Testing System, or “ToRTS” for readers preferring acronyms.  Robots have been used previously for chemical testing, but ToRTs appears to be one of the bigger systems.  EPA says it will use the robot to test 10,000 different chemicals for potential toxicity.  A video of the robot is available here.

ToRTS is located at the National Institutes for Health (NIH) Chemical Genomics Center (NCGC) in Rockville, MD.  It is part of the Tox21 project, which merges existing agency resources (research, funding, and testing tools) to develop ways to more effectively predict how chemicals will affect human health and the environment. The ToRTS system marks the beginning of a new phase of the Tox21 collaboration, which aims to working to protect human health by improving how chemicals are tested in the United States.

Tox21 was established in 2008 between the National Institute of Environmental Health Sciences National Toxicology Program (NTP), the National Human Genome Research Institute (NHGRI), and the EPA.  The U.S. Food and Drug Administration (FDA) joined in 2010.  More information on Tox21 is available here