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

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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.

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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.

European Commission Adopts a Common Definition of "Nanomaterial"

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Nanotechnology:

On October 18, 2011, the European Commission officially adopted the definition of “nanomaterial” set out in its Recommendation.  In the Recommendation, “nanomaterial” is defined in the following manner.

  • “Nanomaterial’ means a natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm.  In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50 % may be replaced by a threshold between 1 and 50 %.

  • By derogation, fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm should be considered as nanomaterials.

  • For the purposes of the definition of “nanomaterial,” the terms ‘particle’, ‘agglomerate’ and ‘aggregate’ are defined as follows:

(a) ‘particle’ means a minute piece of matter with defined physical boundaries;

(b) ‘agglomerate’ means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components;

(c) ‘aggregate’ means a particle comprising of strongly bound or fused particles.

Many members of the nanotechnology community will note with interest what the definition specifically includes and excludes by implication.  For example, the definition includes both natural and incidental materials, as well as aggregates and agglomerates of primary particles in the nanoscale (i.e, generally 1 – 100 nm).  The definition implicitly excludes materials having a surface or internal structure at the nanoscale; in other words, the definition is particle/object-focused.  Thus, the scope of the definition differs in important ways from those established by other members of the international community, such as the International Organization for Standardization’s Technical Committee 229  (ISO TC 229).  Also of interest will be the Commission’s decision to identify nanomaterials by particle number size distribution, which appears to be a reasonable approach to determining whether a material falls within the nanoscale, assuming reliable measuring techniques can be developed and standardized.

The Recommendation requires a review of the definition by December 2014 to ensure the definition remains adequate for its needs.  For example, the review will assess whether the number size distribution threshold of 50% should be increased or decreased and whether materials with nanoscale internal or surface structures should be included. 

With the adoption of a common definition for legislative, regulatory and policy purposes, the EU should achieve greater consistency in the way nanomaterials are identified for purposes of risk assessment and management.  Currently, there are several pieces of EU legislation (e.g., the Cosmetics Regulation, EU Regulation 1223/2009) and implementing guidance that either include a definition of “nanomaterial” or make reference to the term.  Consistency in how these materials are identified in the different regulatory areas should provide greater certainty and predictability for the regulated community and other stakeholders, and may even foster more innovation and increased confidence in safety claims and evaluations. 

Further information, including a Question & Answer document, is available here and here.

Phil Moffat Will Speak About Green Marketing at the 2011 ASC Fall Conference and Expo

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Green Marketing:

Verdant is pleased to announce that Philip Moffat will speak at the 2011 ASC Fall Conference and Expo in Indianapolis, Indiana on October 16 – 18.  Phil will discuss marketing and enforcement trends, the tools available to regulate green marketing in the U.S. and elsewhere, and the legal risks attending the marketing of “sustainable” packaging or other “green” products for which universally accepted metrics and definitions are lacking.  

More information about the Fall Conference and Expo is available here.  A copy of the presentation is available here.

EPA to Identify Priority Chemicals for Review

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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

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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 Publishes Rule to Improve Reporting of Chemical Information – Chemical Data Reporting Rule, Formerly Inventory Update Rule

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TSCA – Inventory Update Rule:

Readers may recall a post from this time last year concerning EPA’s proposal to revise TSCA’s Inventory Update Rule.  Well, the Agency has now published the final version, which is available here.  Also, here are links to commentary on the rule from Environmental Defense and the National Petrochemical and Refiners’ Assocation, which should give readers a flavor of the contrasting opinions currently circulating.  Embedded below is a copy of EPA’s press release.  Check back soon for a more detailed posting, setting out a short analysis of the rule.

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WASHINGTON – The U.S. Environmental Protection Agency is increasing the type and amount of information it collects on commercial chemicals from chemical manufacturers, allowing the agency to better identify and manage potential risks to Americans’ health and the environment. The improved rule, known as the chemical data reporting rule (CDR), also requires that companies submit the information electronically to EPA, rather than on paper, and limits confidentiality claims by companies. The changes are part of EPA Administrator Lisa Jackson’s commitment to strengthen the agency’s chemical management program and increase the transparency of critical information on chemicals. 

“Collecting this critical information on widely used chemicals will enable EPA to more effectively identify and address potential chemical risks,” said Steve Owens, assistant administrator for EPA’s Office of Chemical Safety and Pollution Prevention. “The new electronic reporting requirement and limits on confidentiality claims also will bring EPA’s data collection effort into the 21st Century and give the American people greater access to a wider range of information on chemicals to which their children and families are exposed every day.”

The CDR rule, which falls under the Toxic Substances Control Act inventory update rule (IUR), requires more frequent reporting of critical information on chemicals and requires the submission of new and updated information relating to potential chemical exposures, current production volume, manufacturing site-related data, and processing and use-related data for a larger number of chemicals. The improved information will allow EPA to better identify and manage risks associated with chemicals.

EPA is requiring companies to submit the information through the Internet, using EPA’s electronic reporting tool. On-line reporting will improve both data quality and EPA’s ability to use the data, as well as make it more accessible to the public.

Companies will be required to start following the new reporting requirements in the next data submission period, which will occur February 1, 2012 to June 30, 2012.

More information about the CDR Rule and reporting program is available at www.epa.gov/iur.

Upcoming Event: Chemical Regulation in Canada – Lessons for U.S. Reforms

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TSCA/CEPA:

Readers attending the ABA’s meeting in Toronto in August may be interested in the following event concerning the Canadian system for regulating industrial chemicals and lessons that system may offer the United States as it debates TSCA Reform.  A short description is embedded below, and more information about the annual meeting is available here.  The list of speakers is impressive, so the event should prove worth the time investment. 

3:45 p.m. to 5:15 p.m.

Chemical Regulation in Canada—Lessons for U.S. Reforms

Room 801A, 800 Level, MTCC, South Building

Everyone agrees that chemical regulation in the US needs to be updated. Industry, NGOs and the EPA all find fault with TSCA, the 1976 law that still governs the process. The EU and Canada are both implementing new, ambitious programs that provide models and cautionary experiences for US reforms. The EU’s REACH program has been widely criticized for needless expense and complexity and for producing slow results. The Canadian Environmental Protection Act, by contrast, is frequently cited by stakeholders as a better approach. This program will focus on features of CEPA that make it apparently more efficient and productive, and explore how compatible those processes would be with US law and expectations regarding transparency, participation and due process.

Moderator:

James Conrad, Washington, D.C.

Panelists:

Joseph Castrilli, Toronto, Ontario, Canada

Mark Duvall, Washington, D.C.

Robert Fishlock, Toronto, Ontario, Canada

Karen Levins, Mississauga, Ontario, Canada

Additional Sponsor:

Section of Environment, Energy, and Resources

 

ECHA Publishes the 2011- 2013 Work Program of the REACH and CLP Enforcement Forum

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REACH/CLP Enforcement:

On July 6, 2011, the European Chemicals Agency (ECHA) published the 2011 -2013 work program for the Forum on Exchange of Information on Enforcement of the REACH and CLP Regulations.  The program lists the Forum’s current and upcoming activities, a description of the activities, the expected time frame for each, and its priority.  Readers less familar with the REACH and CLP Regulations should know that the Forum coordinates a network of authorities responsible for enforcement of the regulations in each country or “Member State.”

Very high priority activities for the work period include the follwing: 

  • EU-wide coordinated REACH Enforcement Projects (REFs) such as the coordinated project concerning downstream user obligations of formulators of mixtures;
  • clarification of the links between ECHA, Member State competent authorities and Member State enforcement authorities;
  • access to REACH-IT by Member State enforcement authorities;
  • cooperation with customs authorities, including execution of a coordinated enforcement initiative; and
  • preparation of advice concerning the enforceability of REACH restriction proposals.

In addition, new rules of procedure for the Forum adopted at the recent ECHA Management Board meeting are published, along with minutes of the Forum meeting held in March of this year. 

Copies of the documents are avaialble here.

Pesticides, Nanoscale Materials, and FIFRA

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FIFRA/Nanotechnology:

Guest Column: 
Kathryn Brausch & Irene Hantman
Law Clerk & University of Maryland Law Fellow
US EPA Office of Civil Enforcement
 

Readers interested in EPA’s regulation of nanoscale materials may want to know about recently proposed policies under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) that would affect the use of nanoscale materials in pesticide products.   

On June 17, 2011, EPA published a Federal Register notice (76 FR 35383), requesting comments on two alternative approaches for obtaining information on nanoscale materials, both active and inert ingredients, used in currently registered pesticide products.  The Agency also requested comments on a proposal that would affect the classification of registration applications for pesticide products containing nanoscale materials.  An overview of these proposals, and a summary of their scientific basis, is set out below.

The Scientific Basis

In the Federal Register notice, the Agency reviews the growing body of scientific evidence concerning the human health and environmental hazards of certain nanoscale materials, some of which are used in pesticide products.  After reviewing the evidence, EPA concludes that it indicates that significant differences exist between many nanoscale materials and their non-nanoscale counterparts.  Although some of the differences have beneficial applications, some of them pose new or increased hazards.  EPA reasons that these potential “new” hazards warrant further regulatory scrutiny.

The Alternatives for Collecting Information

The scientific evidence has led EPA to conclude that collecting information from registrants of existing pesticide products is relevant to the Agency’s statutory obligation.  Under FIFRA, EPA has a statutory obligation to determine whether the registration and use of a pesticide may cause unreasonable adverse effects on the environment or human health.  This finding is required for “each and every pesticide product, regardless of whether another pesticide product with the same or similar composition and use patterns is already registered.”  Thus, according to EPA, the presence of a nanoscale material in a pesticide formulation provides a sufficient basis for the Agency to request additional information that may be used to characterize potential risks that may not have been considered when the pesticide was originally registered.  Although the presence of nanoscale materials is sufficient to justify the proposed requests for information, the Federal Register notice stresses that the presence of a nanoscale material is not, by itself, an indicator of potential adverse effects.  However, EPA will use the information it receives from registrants to assess whether additional data are necessary to support continuing the registration and whether amending a registration is necessary to prevent such adverse effects.    

According to the proposed policy, EPA would use one of the two alternative processes summarized in the bullet-points below to collect the data and other information needed.  The process would apply to both active and inert nanoscale ingredients.  

— Under one alternative, EPA would formally announce that ‘reportable’ information required under FIFRA §6(a)(2) includes information on the presence of nanoscale materials. Following the formal policy announcement, any registrant with such information would have 30 days to submit it to EPA.  Specifically, each registrant that knew it had a registered product containing a nanoscale material would provide existing information concerning:  (1) the identity of the affected product; (2) the identity of the nanoscale materials in the product; (3) the size or size distribution of the nanoscale materials; (4) the manufacturing process used to produce them; (5) the size and size distribution of the composite matrix, if any, containing the materials; and (6) the data showing adverse effects at any level of exposure, and the nature and levels of human and environmental exposure.  This alternative has proven controversial because section (6)(a)(2) concerns “adverse effects” reporting – members of the nanotechnology community therefore worry that use of this section would create a stigma for all nanoscale materials used in pesticide products.

— Under a second alternative, EPA would issue data call-ins under FIFRA §3(c)(2)(B) to specific groups of registrants. The scope of information collected would potentially be the same under this alternative as it would be under the other one, but registrants would be given 90 days to respond.  EPA could also request the generation of new data and information, which it cannot request under the other alternative.  Moreover, the burden on industry and EPA would increase.  Typically, registrants that receive such data call-in requests are required to respond even when they don’t have the requested information. And EPA would have to track its requests to identify non-responders warranting enforcement. 

Under either alternative, EPA would use the information it received to determine whether additional data needs to be generated or whether a registration should be cancelled or amended to prevent unreasonable adverse effects. 

The New Classification of Applications

EPA also announced a policy affecting the classification of applications seeking to register pesticide products containing nanoscale materials.  Under the new approach, EPA would presume that active or inert nanoscale ingredients are potentially different from non-nanoscale versions of those ingredients that were previously registered.  EPA also would presume that one nanoscale version of an ingredient is potentially different from another, already-registered nanoscale version of the same ingredient.  Based on these presumptions, EPA would initially classify all such applications as applications for “new” ingredients, increasing the application fee, the time EPA has to review the application, and the amount of information it may require.  An applicant could overcome the presumption by proving that the nanoscale version to be registered is sufficiently similar to the registered version or differs only in ways that do not significantly increase the risk of unreasonable adverse effects or require different registration terms or conditions.  If successful, EPA would review the application in a shorter timeframe and allow the applicant to rely on the data from the previous registrant, subject to appropriate compensation where required.

This proposed policy also has significant compliance implications.  Specifically, a company would potentially violate the registration requirements by substituting nanoscale ingredients for non-nanoscale ingredients without first notifying EPA and receiving Agency approval.  Assuming the policy is finalized, it is clear that substitutions occurring after the policy announcement would face a significantly increased risk of having violated the registration requirements.  However, the Federal Register notice is less clear with respect to the legal implications of substitutions that occurred before announcement of the new policy — such substitutions might be considered potential violations of the registration requirements or the section 6(a)(2) reporting requirements.

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Once adopted, the policies announced in the above-cited Federal Register notice are likely to be the first of many policies EPA develops to address the use of nanoscale materials in consumer products and other product types.  Accordingly, those using such materials should be prepared for additional inquiries about their use of such materials and their potential effects.

 DISCLAIMER: This work is not a product of the United States Government or the United States Environmental Protection Agency. The views expressed are those of the authors only and do not necessarily represent those of the United States or the US EPA.

 

Reminder: Upcoming Meeting of the California Green Ribbon Science Panel

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Green Chemistry Regulations:

For readers interested in learning more about the development of California’s Green Chemistry Regulations – the “Safer Consumer Product Alternative Regulations” – the upcoming meeting of the Green Ribbon Science Panel may be of interest.  Details are set out below in the embedded announcement from the Department of Toxic Substances Control (DTSC).  Enjoy!

DTSC: Green Chemistry Initiative

 The Department of Toxic Substances Control (DTSC) will convene the Green Ribbon Science Panel (GRSP) on Thursday, July 14, 2011, from 9:30 a.m. to 5:00 p.m. (PDT), and on Friday, July 15, 2011, from 8:30 a.m. to 12 noon (PDT) in Sacramento, California and via webcast. The public is invited to attend, and comments to the GRSP on agenda items are welcome.

 Meeting notice:

http://www.dtsc.ca.gov/PollutionPrevention/GreenChemistryInitiative/upload/GRSP_7-14_PN.pdf

Meeting agenda:

http://www.dtsc.ca.gov/PollutionPrevention/GreenChemistryInitiative/upload/GRSP_7-14_Agenda.pdf