The EPA Inspector General's Report

The task of the Inspectors General of Federal agencies is to examine "all actions of a government agency or military organization. Conducting audits and investigations, either independently or in response to reports of wrongdoing, the OIG ensures that the agency's operations are in compliance with the law and general established policies of the government. Audits conducted by the OIG are intended to ensure the effectiveness of security procedures, or to discover the possibility of misconduct, waste, fraud, theft, or certain types of criminal activity by individuals or groups related to the agency's operation."

At the end of 2011, the Office of the Inspector General (OIG) of the Environmental Protection Agency (EPA) posted Report No. 12-P-0162,"EPA Needs to Manage Nanomaterial Risks More Effectively" to the reports section of its website.

The OIG, in the Introduction to the report, states that the

. . .  purpose of this review was to determine how effectively the U.S. Environmental Protection Agency (EPA) is managing the human health and environmental risks of nanomaterials.

The report notes that

EPA has the statutory authority to regulate nanomaterials. . . . EPA can regulate nanomaterials during their manufacture, formulation, distribution in commerce, use, and/or disposal through the Toxic Substances Control Act (TSCA) . . . nanomaterials in pesticides through the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) . . . . EPA can regulate nanomaterials released into the environment using the Clean Air Act; the Clean Water Act; the Comprehensive Environmental Response, Compensation and Liability Act; or the Resource Conservation and Recovery Act.

However, while EPA is armed with this authority and while EPA has shifted in recent years from depending on nanoindustries to voluntarily supply EPA with information on "production, importation, and use; exposures; risk management practices; hazards; pollution prevention; and physical and chemical properties" to a more active "regulatory approach", "to collect nanomaterials data from manufacturers of industrial chemicals", the OIG, after conducting "this performance evaluation in accordance with generally accepted government auditing standards", "identified a number of shortcomings": At least some of these shortcoming were attributable to the limitations of TSCA:

1) " . . . An absence of toxicity testing and environmental fate data, and a reliance on modeling . . . .Because EPA depends on information reported by industry, it can initially fail to identify chemical risks not self-disclosed by manufacturers."

2) "The program was limited by TSCA's requirement to protect claims of confidential business information (CBI) on industry data submissions. . . . Excessive CBI designations inhibit independent peer reviews, oversight by external parties, and information sharing across EPA offices".

Other short comings are based in structural problems:

1) "EPA doesnot have an agency-wide formal process to disseminate manufacturer data gathered from TSCA and FIFRA data calls." This data is shared between offices only via informal personal relationships (a.k.a "The Grapevine") such as can be found in any office setting. While this form of communication may work to a limited extent, its limits are obvious.

"Because of the growing number of nanomaterial products entering the marketplace and the anticipated receipt of TSCA and FIFRA data following approval of . . . requested information gathering rule changes, it will be increasingly necessary for . . .offices [in EPA] to formally share information anc coordinate their efforts."

Other short comings found by the OIG recall a line from the movie Cool Hand Luke :

Captain, Road Prison 36: What we got here is... failure to communicate.
 

"Through Federal Register notices, program office web pages, public presentations, and meetings EPA has sought to communicate information related to nanomaterials and to gather input from stakeholders. However, the agency as a whole has not provided a transparent overall message about nanomaterials to the general public. . . .The agency should be prepared to communicate to the public any nonconfidential risk information generated or collected through its FIFRA, TSCA, and reseach activities because nanomaterials is emerging issue, it will be important for EPA to keep the public informed on the benefits and risks, how the public might be exposed, and what regulatory approach the agency is taking."

Other short comings are based on the limitations created by (1) a lack of technology designed to detect nanomaterials or remove detected nanomaterials from the ambient atmosphere (" . . .the agency may not be able to monitor, identify, and remediate nanomaterial comtamination if it were to occur in the natural environment") and (2) resource limitations. EPA, like all Federal, State, County and Municipal agencies, constantly face the potential for budget cuts that would severely limit agency programs.

The OIG's report concludes with the recommendation that the EPA's Assistant Administrator for Chemical Safety and Pollution Prevention be tasked with developing "a formal process to assure the effective dissemination and coordination of nanomaterial information across relevant program offices."

While EPA has agreed with this recommendation and has created a "correction plan with milestone dates" to create a formal communications process and structure, other shortcomings, as discussed above, are rooted in the limitations of TSCA, FIFRa and other laws refered to above. Changes in those are outside of EPA's control, as are those caused by the vagaries of budgets and the appropriations process.

Legislation to reform and strengthen TSCA and EPA's regulatory authority have been introduced in both the Senate and the House in both the 111th and 112th Congresses. S.847, the Safe Chemicals Act of 2011, introduced by Senator Frank Lautenberg of New Jersey on April 14, 2011, is the most recent of these bills. Assigned to the Senate Committee on Environment and Public Works Subcommittee on Superfund, Toxics and Environmental Health, hearings on the bill were held on November 17, 2011. No further action on the bill has occured and with elections coming in November of this year, it is unlikely that the bill will be reported out of committee and sent to the Senate floor for debate.

EPA Extends comment period

Wednesday's Federal Register carried a notice from the Environmental Protection Agency (EPA) extending the comment period for proposed methods of collecting information regarding the use of nanoscale materials in pesticides published in the Federal Register of June 17, 2011. The original deadline for submitting comments was July 18, 2011. The deadline for submission has been extended to august 17, 2011.

The 30 day extension was requested by four commenters - Croplife America, a trade group repsenting " the developers, manufacturers, formulators and distributors of plant science solutions for agriculture and pest management in the United States", the American Chemical Council, the Chemical Producers and Distributors Association, a trade group "representing the interests of generic pesticide registrants, with a membership that includes manufacturers, formulators, and distributors of pesticide products", and theInternational Center for Technology Assessment, "a non-profit, bi-partisan organization committed to providing the public with full assessments and analyses of technological impacts on society". The comments may beviewed on Regulations.gov.

Information on submitting comments is available from either the original notice or the notice published on Wednesday.

EPA Requests Public Comment on Obtaining Information Regarding Nanomaterials in Pesticides

On June 17, 2011, the Environmental Protection Agency (EPA) published a notice in the Federal Register announcing that it was seeking "comment on several possible appraoches for obtaining information about what nanoscale materials are present in registered pesticide products. . .  . and its potential effects on humans or the environment. . . ."

Under one approach to collecting this information, EPA would use the authority granted to it by the Federal Insecticide, Fungicide,and Rodenticide Act  (FIFRA) to require applicants to "provide any factual information of which [the applicant] is aware regarding unreasonable adverse effects of the pesticide on man and the environment". If EPA adopts this approach, it would require the inclusion of "such information with applications for registrations of pesticides or pesiticide products containing 'nanoscale materials'".

Under a different section of FIFRA, EPA would gather information using Data Call-In notices.

EPA is required to collect information regarding pesticides under section 3(a) of FIFRA. Using the information collected, EPA can then determine

1) the validity of the products claims

2) that labelling complies with FIFRA requirements

3) that the pesticide or pesticide product will not cause unreasonably adverse harm to humans or the environment.

EPA "believes that certain information concerning pesticide ingredients" - in this case, nanoscale materials, defined by EPA as (1) between 1 and 100 nanometers, (2) " exhibit unique and novel properties compared to larger particlesof the same material" and (3) has been manufactured or engineered at the nanoscale level to take advantage of those unique or novel properties - have not been routinely provided to EPA, complicating the agency's attempts to fulfill its legal obligations.

In determining whether an ingredient meets this description, EPA
may review particle size data and, among other things, the
manufacturing process to determine whether it employs processes
specifically to create or enhance the proportion of nanoscale materials
in the product, as compared with other processes used to produce
similar products. The Agency generally expects that these ingredients
may comprise, but are not limited to, metal-based (e.g., silver) and
carbon-based (e.g., carbon nanotubes) nanoscale materials. . . EPA would
review information provided by a registrant or applicant concerning the
composition of the pesticide product and to provide an Agency view on
whether the product did (or did not) contain a nanoscale material for
purposes of this policy.

 

Noting that ". . . there is a growing body of scientiific evidence showing that differences can exist between nanoscale material[s] and their non-nanoscale counterpoint[s]. . . EPA sees the emergence of nanoscale materials as offering . . .potential benefits for society in many different fields, including pest control products". Among these potential benefits are :

1) creation of more effective and efficient targeting of pesticide products

2) use of smaller quantities of pesticide products, reducing the amount of pesticides circulating in the environment

3) reducing the frequency of usage of these products.

All of these benefits would lead to "improved human and environmental safety and could lower pest control costs. . .. EPA seeks to encourage innovative work in developing nanoscale materials to realize these benefits".

But while EPA may be encouraging innovative work to realize those benefits, it is also aware that

the small size . . . or the unique or enhanced properties of nanoscale materials may, under specific conditions, pose new or increased hazards to humans and the environment. . . . It is important to empasize that  . . any individual type of nanoscale material may
not display all or even any of the characteristics observed and
reported for other nanoscale materials. In other words, some nanoscale
materials may have properties which, for purposes of assessing the risk
of a pesticide, are essentially identical to larger sized materials (or
particles) of the same substance. Furthermore, nanoscale materials may
also have properties that make them less risky, or more beneficial in
some other way, than larger sized materials (or particles) of the same
substance. So, it appears increasingly likely that there are few, if
any, universal ``nanoscale'' effects, and the distinctive effects seen
at nanoscale are specific to the properties of each material type under
specific exposure scenarios. Thus, EPA does not regard the fact that an
ingredient meets our description of a nanoscale material as evidence
that a pesticide containing the ingredient would cause unreasonable
adverse effects on the environment and thus would no longer meet the
statutory standards for registration. Rather, the presence of a
nanoscale material in a pesticide is grounds for EPA to consider the
possible need for data to characterize the potential of the ingredient
to pose risks. However, the registration status of a product would not
change merely as a result of providing information to EPA about the
presence of a previously-unreported nanoscale material. If, based on a
science based assessment of the risks of the specific pesticide
ingredients involved, EPA were to determine that the pesticide no
longer met the criteria for registration, or that some change was
needed in the conditions of use, EPA would conduct a separate action to
notify the manufacturer of that determination, consistent with current
FIFRA regulations.
    Finally, scientifically speaking, there currently is no bright line
with respect to a size below (or above) which nanoscale materials do
(or do not) exhibit properties that might be of interest in assessing
whether a pesticide product has the potential to cause unreasonable
adverse effects on the environment. Therefore, the precise size range
in nanometers addressed by the policies proposed in this document might
be revised in the future as new information becomes available.

EPA believes that any of the
following types of information are relevant to assessing the potential
of a pesticide to cause unreasonable adverse effects on the
environment:
    Any information concerning what nanoscale materials are
present in pesticides, whether as an active ingredient or as an inert
ingredient;
    For any pesticide product that contains nanoscale
material, whether active or inert, any existing information that
characterizes the size and size distribution of the nanoscale material
as measured in nanometers;
    For any pesticide product that contains nanoscale
materials, whether active or inert, any existing information that
describes the manufacturing process used to produce the nanoscale
material in whatever size range it is produced;
    For any pesticide product that contains nanoscale
materials, whether active or inert, and that also is or will be used
for an end-use formulation that contain(s) a composite (e.g., the
active ingredient is a matrix complex comprised of the nanoscale
material(s) in combination with a carrier, such as silica or sulfur),
any existing information that characterizes the size and size
distribution of the composite; and
    For any pesticide product that contains nanoscale
materials, whether active or inert, any existing information that shows
adverse effects at any level of exposure to the nanoscale material on
humans or nontarget species, and/or that shows the levels or nature
(e.g. routes, frequency, or life stage) of potential human and environmental exposure.
. . . . the foregoing is not intended to be an exclusive list.
To the extent that a registrant has a pesticide product that contains a
nanoscale material, and in addition has any other existing information
not captured in the previous list that pertains to, concerns, or
otherwise relates to the nanoscale material and has the potential to
raise questions about the continued registration of a product or the
appropriate terms and conditions of a product registration, EPA is also
considering whether this too should be submitted to the Agency.
 

The main purpose of this notice was to solicit comments regarding how EPA will collect information regarding nanoscale materials in pesticides or pesticide products. As stated above, EPA is considering two methods.

The first is to require that information submitted by registerants of pesticides under 6(a)(2) of FIFRA include information about nanoscale materials.

Noting that some stakeholders have objected to this method of collecting information as (1) potentially stigmatizing nanoscale materials as causing "adverse effects" on humans and/or the environment and (2) "overly burdensome", EPA notes that

1) " It is . . .EPA's position that . . .filing an additional report . . .doesnot stigmatize pesticides and wouldnot stigmatize any nanomaterials in pesticides since filing such reports is quite common."

2) . . . only registrants who know that their products contain nanoscale
materials would be required to report to EPA. Further, they would be
required to report only the information they know about. Section
6(a)(2) does not require a registrant to generate new data or to seek
out additional information. Further, registrants and applicants whose
products do not contain nanoscale materials (or who do not know that
their products contain nanoscale materials) would have no reporting
obligation under FIFRA section 6(a)(2).

Alternatively, EPA could gather the information it needs by using the authority granted to it under section 3(c)(2)(B) of FIFRA to issue Data-Call In Notices and to require the inclusion of this information "with any application for registration of a pesticide product that contains a nanoscale material". The use of DCIs would prove burdensome for both EPA and registrants, requiring the former to have to create new administrative procedures to monitor the intake and processing of reports, and for the latter, who would have to generate data about it's products that it didn't have

Under either the 6(a)(2) or the 3(c)(2)(B) approach, DCIs targeted
to individual pesticide products that contain specific nanoscale
materials would likely be used in the future to collect more specific
information or data about particular products. EPA would consider doing
so on a case-by-case basis and would tailor any request for information
accordingly.

 

Some stakeholders have suggested that EPA simply propose a new regulation to require the disclosure of what nanoscale materials are present in a pesticide as part of the application for registration of a pesticide. EPA, while not considering proposing such a regulation at this time, is also seeking comment on that appraoch.

EPA is also considering a change in policy in how it classifies applications for registration of pesticides with nanoscale materials

. . . . EPA is thus proposing that it not make
the requisite findings absent specific information on the nanoscale
material included in a pesticide product when the application relies on
a comparison to a currently registered pesticide product containing
either a non-nanoscale version of the same ingredient or another
nanoscale version of the ingredient that has different characteristics. 
. . . .  EPA would initially classify any application for
registration of a pesticide product containing an active or inert
ingredient that is a nanoscale material as an application for a ``new''
active or inert ingredient, even when another registered pesticide
product contains a non-nanoscale form of the ingredient or a nanoscale
form of the ingredient with different size dimensions or other
properties. This initial presumption, however, could be rebutted on a
case-by-case basis through the submission of, among other
possibilities, bridging data or other information demonstrating to
EPA's satisfaction that the nanoscale material's properties, which are
relevant to assessing the potential risks to human health and the
environment, are substantially similar to the properties of the
already-registered non-nanoscale or already-registered nanoscale form
of the material, or that the nanoscale material differs only in ways
that do not significantly increase the risk of unreasonable adverse
effects on the environment, and that approving the registration in the
manner proposed would not significantly increase the risk of any
unreasonable adverse effect on the environment.
    If an applicant could make this showing to EPA's satisfaction, then
the application would be processed as a ``me-too'' application within
the timeframes prescribed for such applications.

EPA concludes the notice by presenting several questions for respondents to consider:

EPA  specifically invites comments on the following issues:
    1. In view of the Agency's goal of identifying what nanoscale
materials are in products so that EPA can determine whether it needs
additional data to evaluate the products' safety under FIFRA, should
EPA change the description of a ``nanoscale material''? For example,
should the size range remain ``between approximately 1 and 100 nm in
one dimension''? Are there other characteristics that EPA should
consider, e.g., morphology, including shape and crystal structure;
surface chemistry and reactivity; specific surface area, charge;
solubility; conductive, magnetic, and optical properties?
    2. Should the reporting requirement apply only to nanoscale
material that is ``intentionally produced to have at least one
dimension that measures between approximately 1 and 100 nanometers,''
or should it also apply to naturally occurring materials? Why?
    3. Is the meaning of ``intentionally produced'' sufficiently clear?
If not, in what circumstances would the term be unclear and how might
it be clarified? Would offering a consultation procedure--by which a
registrant or applicant describes to EPA the production process that
results in the presence of a material in the nanoscale size range, and
EPA responds with a determination regarding whether reporting is
required--be an acceptable approach to providing clarity?
    4. Should the reporting requirement apply to ingredients in
pesticides that contain any amount of a nanoscale material, or should
the requirement apply only if an ingredient contains more than a
specified percentage (e.g., 10%) of nanoscale material? If the latter,
what should the specified percentage be and why?
    5. How should the reporting requirement apply to a pesticide
manufacturer who purchases ingredients that may contain nanoscale
material?
    6. Are there ways in which the description of ``nanoscale
materials'' can be refined and clarified, including ways in which
agglomeration and aggregation could be considered as well as
suggestions for ways in which more subjective criteria, such as
``unique or novel properties'' can be incorporated into the screening
criteria?
    7. Is EPA's description of ``nanoscale material'' inconsistent with
other definitions of nanoscale material or similar terms? If so, please
comment on whether such differences create any regulatory issues. In
particular, does the focus on ``intentionally produced'' materials
create any such inconsistency with other definitions of nanoscale
materials or similar terms?
    8. If a pesticide is identified as containing a particular
nanoscale material, what would be the most useful next steps to inform
EPA's understanding of potential risks associated with the pesticide?
Are there tests that could provide useful information toward an
understanding of risk that would be common to all nanoscale materials,
or should the data requirements necessarily be compound- and situation-
specific? How should bioavailability be considered in determining
testing requirements (e.g., are nano-particles respirable or bound to
other components)?
    With respect to the proposed approaches, EPA is seeking comment on
how to implement them to ensure efficient, effective, and timely review
of applications. EPA specifically invites comments on the following
issues:
    1. Is there a way to determine, in advance of receiving an
application for registration of a product containing a nanoscale
material, whether a particular kind of nanoscale material has
properties that, for purposes of risk assessment, are essentially the
same as larger sized materials of the same substance? If so, how would
such determinations be made and on what would they be based?
    2. What kinds of information should EPA accept as demonstrating
that a pesticide product containing a nanoscale ingredient is identical
or substantially similar to a currently registered pesticide or differs
only in ways that would not significantly increase the risk of
unreasonable adverse effects on the environment, and that approving the
registration in the manner proposed would not significantly increase
the risk of any unreasonable adverse effect on the environment?
    3. Can you suggest any alternative(s) to the proposed approaches
that would be equally or even more effective in addressing the status
of nanoscale materials as new active or inert ingredients for purposes
of both FIFRA and PRIA, keeping in mind the data showing that size,
especially when reduced below approximately 100 nm, may alter the
manner in which materials behave and, in turn, the potential risk to
human health and the environment associated with such materials?
    With respect to the potential alternative ways of obtaining the
needed information on what nanoscale materials are in pesticide
products, EPA specifically invites comments on the following issues:
    1. Has EPA appropriately characterized in this document the current
scientific understanding of the potential risks of nanoscale materials?
If not, please comment on how to characterize the potential risks of nanoscale materials. How would the  perception of the risks of nanoscale materials differ depending on the  approach used by EPA to require needed data on nanoscale materials in  pesticides? How could EPA lessen the possibility that issuance of a
final requirement to report what nanoscale materials are in pesticides
will result in a public misunderstanding of the potential risks of
nanotechnology more generally?
    2. Do commenters believe that identification of the nanoscale
materials in pesticide products is relevant to EPA's statutory
determination regarding the potential for unreasonable adverse effects
on the environment? Please provide the scientific or legal basis for
your view.
    3. Has EPA characterized the alternative approaches with respect to
which they would: (a) result in a misunderstanding of the potential
risks posed by nanoscale materials; (b) result in the timely submission
of needed information; and (c) impose burdens on pesticide companies,
those whose products do, and do not, contain nanoscale materials? If
not, please comment on those issues.
    4. If EPA uses FIFRA section 6(a)(2) to obtain the needed
information on nanoscale materials in pesticides, how could the Agency
ensure that its action is not mischaracterized or misunderstood as a
determination that the mere fact that a pesticide contains nanoscale
materials causes unreasonable adverse environmental effects?
    5. If EPA were to use DCIs to obtain the needed information on
nanoscale materials in pesticides, how could EPA reduce both the
burdens on registrants and on EPA, as well as the time required to
complete such a process? For example, is it possible to reduce the
burdens on registrants by targeting only certain types of products? If
so, how would EPA determine which products should receive DCIs?
    6. What are the advantages and disadvantages of requesting
information on nanoscale materials specifically versus requesting
information on size distribution generally? (Note that either type of
information could be collected under either the 6(a)(2) or the
3(c)(2)(B) approach, except that 6(a)(2) cannot be used to require the
production of new information that does not already exist, while a
collection under 3(c)(2)(B) must be directed to an individual
registrant and requires a response.) Is identifying what nanoscale
materials are in products a useful first step, or should EPA move
towards immediate collection of more specific information, such as
particle size distribution, on products that might contain nanoscale
materials? Are there other physical and/or chemical properties that
might be equally or more important for assessing the potential of a
pesticide to cause unreasonable adverse effects on the environment
(e.g., morphology, including shape and crystal structure; surface
chemistry and reactivity; specific surface area, charge; solubility;
conductive, magnetic, and optical properties)? Should information on
these properties be separately requested? What would be the value and
burden of obtaining such information?
    1. If EPA were to use rulemaking to establish data requirements for
pesticides containing nanoscale materials, what types of information
should EPA use to determine appropriate data requirements? What types
of studies should EPA require to evaluate a nanoscale material?
    2. When choosing an approach for obtaining needed data, how should
EPA weigh considerations relating to the need to update its safety
evaluations of currently marketed pesticides in a timely manner, the
goal of ensuring marketplace equity, and the interest in minimizing the
burdens on regulated entities?

 

Comments need to be filed by July 18, 2011, either in an e-format via www.regulations.gov or delivered in paper to

Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
    Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
   

Further information on submitting comments may be found at the head of the notice. A docket - EPA-HQ-OPP-2010-0197 - has been established on the Regulations.gov site. A few comments have been filed and may be viewed there, along with supporting and related materials used by EPA in drafting this notice. Members of the Nanotech community are encouragef to file appropriate comments by the July 18, 2011 deadline. Following receipt and review of comments filed by the July 18, 2011 deadline, EPA will publish another notice summarizing the comments.

EPA to Issue New Carbon Nanotube Significant New Use Rule

Here is an advance copy of a new multi-walled carbon nanotube significant new use rule being published tomorrow in the federal register.  It applies only to the specific carbon nanotubes that were the subject of PMN P-08-199, and binds anyone who intends to manufacture, import, or process the specific chemical substance.  It is largely consistent with past SNURs and Consent Orders for other CNTs.  For those wondering, "processors" and "processing" is broadly defined under TSCA.  It has been used in the past to include repackaging for commercial purposes, using the material in the manufacturing of new mixtures, and/or the production of articles using the substance.

Nanoscale Carbon Toxicity Testing Proposal Submitted to EPA

 

 

The NanoSafety Consortium for Carbon just submitted a proposed toxicity testing agreement to EPA under Section 4 of the Toxic Substances Control Act covering a range of nanoscale materials including multi-walled carbon nanotubes, double-walled carbon nanotubes, single-walled carbon nanotubes, and graphene. 

 

Key elements for the curious:

  • The chemical substances to be tested may include representative (i) purified multi-walled carbon nanotubes ranging from 4 to 600 nanometers in diameter and less than 30 micrometers in length; (ii) purified double-walled carbon nanotubes ranging from 1.5 to 4 nanometers in diameter and less than 5 micrometers in length; (iii) purified single-walled carbon nanotubes ranging from .7 to 2 nanometers in diameter and less than 30 micrometers in length; and (iv) purified graphene nanoplatelets in flake/sheet form ranging from .5 nanometers to 100 nanometers thick. All test materials will be purified by the National Institute of Standards and Technology to be at least 99 percent pure. Final test materials will be approved by the EPA and will be selected to adequately represent the constituency of the final signatories to the testing agreement.

 

  • The characteristic for which testing will be conducted is subchronic inhalation toxicity in rodents, or such other toxicity testing as may be approved by EPA to achieve the intent and purpose of the testing agreement. As appropriate, consideration will be given to using in vivo instillation rather than inhalation test methods. Test data will be developed under standards based on TSCA test guidelines in 40 CFR parts 796, 797, and 798, Organization for Economic Cooperation and Development (OECD) test guidelines, or other suitable test methodologies.  Specifically, the signatories will conduct a 90 day inhalation toxicity study in rats with a post exposure observation period of up to 3 months, including broncholaveolar lavage fluid analysis (OPPTS 870.3465 or OECD 413), or such other testing as may be approved by the EPA to achieve the intent and purpose of the testing agreement. Testing guidelines will be modified to account for nanoscale properties of the materials being tested. Such modifications are subject to EPA approval and will be incorporated into the below-referenced study plan.

If EPA decides to pursue the proposed testing agreement, it will initiate a six-month negotiation and comment period which will open to the public pursuant to 40 C.F.R. § 790.28.

Stay tuned.

 

Three US-UK Consortia Receive EPA Grants for Nanotech Research

On February 17 2011, the EPA, in conjunction with the Consumer Product Safety Commission (CPSC) and the UK's Natural Environmental Research Council (NERC), announced the awarding of $12 million ($5.5 million from the EPA, $500,000 from CPSC, and $6 million from NERC) to three consortia to fund research aimed at providing a greater understanding of potential risks to human health and the environment posed by engineered nanomaterials and their increasing use in a wider variety of products.

The three consortia, the "Consortium for Manufactured Nanomaterial Bioavailability and Environmental Exposure", "Risk Assessment for Manufctured Nanoparticles Used in Consumer Products (RAMNUC)", and "The Transatlantic Initiative for Technology and the Environment", are composed of leading US and UK Universities and research centers, such as Duke University, Carnegie-Mellon University, and Lancaster University. NERC's $6 million is limited to participating universities and research centers in the UK.  The table below provides more information.

#   

Identifier

Abstract

Principal Investigator

Institution

Grant Representative

Grant Amount

Project Period

RFA

1

R834575
Grant

Consortium for Manufactured Nanomaterial Bioavailability & Environmental Exposure

Colvin, Vicki L.
Chipman, Kevin
Fernandes, Teresa
Klaine, Stephen J.
Lead, Jamie
Luoma, Sam
Stone, Vicki
Tyler, Charles
Valsami-Jones, Eva
Viant, Mark
 

Rice University,Clemson University,Edinburgh Napier University,Natural History Museum (London),University of Birmingham,University of California - Davis,University of Exeter

Lasat, Mitch
 

$2,000,000  

August 2010 -
August 2013  

Environmental Behavior, Bioavailability and Effects of Manufactured Nanomaterials - Joint US – UK Research Program (2009)  

2

R834693
Grant

Risk Assessment for Manufactured Nanoparticles Used in Consumer Products (RAMNUC)

Zhang, Junfeng
Chung, Kian Fan
Di Giulio, Richard T.
Garfunkel, Eric
Georgopoulos, Panos G.
Isukapalli, Sastry S.
Kipen, Howard
Lee, Ki-Bum
Lioy, Paul J.
Mainelis, Gediminas
Porter, Alexandra
Ryan, Mary P.
Schwander, Stephan K.
Tetley, Teresa D
 

University of Medicine and Dentistry of New Jersey,Duke University,Imperial College

Lasat, Mitch
 

$1,999,995  

July 2010 -
June 2014  

Environmental Behavior, Bioavailability and Effects of Manufactured Nanomaterials - Joint US – UK Research Program (2009)  

3

R834574
Grant

Transatlantic Initiative for Nanotechnology and the Environment

Bertsch, Paul M.
Casman, Elizabeth
Dorey, Robert
Harris, J.
Jefferson, Bruce
Kabengi, Nadine
Liu, J.
Lofts, Steve
Lowry, Gregory V.
McGrath, Steve
McNear, David H.
Neal, Andy
Ritz, Karl
Rocks, Sophie
Spurgeon, David
Svendsen, Claus
Tsyusko, Olga V.
Unrine, Jason M.
Wiesner, Mark R.
Zhang, Hao
 

University of Kentucky,Carnegie Mellon University,Centre for Ecology and Hydrology,Cranfield University,Duke University,Lancaster University,Rothamsted Research

Lasat, Mitch
 

$2,000,000  

May 2010 -
April 2014  

Environmental Behavior, Bioavailability and Effects of Manufactured Nanomaterials - Joint US – UK Research Program (2009)  

The results of the grant supported research "will help researchers determine whether certain nanomaterials can leach out of products . . . when they are used or disposed of and whether they could become toxic to people and the environment. The results could also be used by nanoindustries to create better and safer products.

 

 

New Nano-specific Regulations Forthcoming from U.S. EPA

This article originally appeared on the National Nanomanufacturing Network's InterNano website. It is licensed under Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported.

In its ongoing efforts to guard against potential unintended environmental, health, or safety injuries related to possible exposure to certain nanoscale materials, the US Environmental Protection Agency (EPA) plans to issue three new proposed nano-specific regulations in January 2011. While EPA is already actively regulating certain nanoscale materials which it considers new chemical substances (e.g./ carbon nanotubes, fullerenes, etc.), the new proposed rules will provide EPA with greater latitude in regulating both new and existing nanoscale materials. Manufacturers working with nanoscale materials should keep a very close eye on these new proposed regulations to determine whether they will be required to comply with any of EPA's final rulings. Additionally, there will be opportunities for public comment and input.

Significant New Use Rule

Advocacy groups have been asking EPA for years to treat nanoscale versions of existing chemical substances as significant new uses of those substances under the Toxic Substances Control Act (TSCA). These types of substances include nanoscale silver, nanoscale TiO2, and nanoscale zinc oxide. Among other things, treating these materials as significant new uses of existing chemical substances would allow EPA to limit their production, require the use of workplace safety measures, require companies to conduct toxicity testing, and require companies to prevent intentional/purposeful releases of the materials to water.

Although its exact parameters have not been released, it appears that EPA intends to issue a proposed significant new use rule under Section 5 of TSCA in January 2011 addressing these issues. While the contours of the rule are difficult to predict, a likely tactic may be to "grandfather in" nanoscale versions of existing chemical substances, but to treat any new attempts to manufacture or use nanoscale versions of existing chemical substances as significant new uses. While such an approach will likely to draw complaints from “newcomers” because companies already manufacturing in the niche would have a distinct competitive advantage, it might be the only workable approach available to EPA. It is virtually impossible to catalogue all existing uses of each nanoscale material already in the marketplace.

Testing Rule

While EPA is already requiring rigorous 90 day in vivo inhalation toxicity testing for certain new nanoscale materials, it appears that the Agency intends to propose a testing rule under Section 4 of TSCA in January 2011 requiring this same type of testing for certain nanoclays, nanoscale aluminum oxide, and nanotubes. Nanoclays and nanoscale aluminum oxide were apparently considered because no country volunteered to be lead sponsor for their testing under the Organization for Economic Cooperation and Development's comprehensive toxicity testing program. Additionally, no manufacturers have submitted premanufacturing notices for nanoclays un the U.S. which might otherwise provide EPA with the chance to require similar testing.

Conducting a 90 day in vivo inhalation test on a nanoscale material is difficult and can cost between $350,000 to $500,000 for each material tested. It will be interesting to see whether EPA’s proposed testing rule will allow for joint testing by manufacturers in order to reduce cost and increase efficiency. At least one group of manufacturers -- the NanoSafety Consortium for Carbon -- is already preparing to ask EPA to use this approach with their nanoscale carbon materials.

Data Collection Rule

Perhaps the broadest proposed rule EPA intends to issue in January 2011 will require manufacturers of nanoscale substances which have not already made formal detailed submissions to EPA to submit detailed EHS data for EPA’s review and consideration. The new proposed rule will be issued under Section 8(a) of TSCA, and will essentially make EPA's prior voluntary Nanoscale Materials Stewardship Program (NMSP) into a mandatory data collection effort. Readers may recall that the NMSP program received lukewarm industry participation, which is apparently resulting in the new mandatory approach.

Fortunately, the TSCA provision authorizing such data-call-ins allows manufacturers to apply to EPA for exemptions in instances where the subject nanoscale materials are only manufactured in small quantities (less than 500 kgs) or are being made solely for research and development purposes.

Finally, for those who might be interested, Section 8(a) of TSCA allows EPA to request information regarding:

  • The common or trade name, the chemical identity, and the molecular structure of each chemical substance or mixture.
  • The categories or proposed categories of use of each such substance or mixture.
  • The total amount of each such substance and mixture manufactured or processed, reasonable estimates of the total amount to be manufactured or processed, the amount manufactured or processed for each of its categories of use, and reasonable estimates of the amount to be manufactured or processed for each of its categories of use or proposed categories of use.
  • A description of the byproducts resulting from the manufacture, processing, use, or disposal of each such substance or mixture.
  • All existing data concerning the environmental and health effects of such substance or mixture.
  • The number of individuals exposed, and reasonable estimates of the number who will be exposed, to such substance or mixture in their places of employment and the duration of such exposure.
  • The manner or method of its disposal, and in any subsequent report on such substance or mixture, any change in such manner or method.

 

EPA Releases SNURS Affecting Multi-Walled and Single-Walled Carbon Nanotubes

In the Federal Register for Friday 09/17/2010, the Environmental Protection Agency (EPA), acting under the authority granted to it under section 5(a)(2) of the TSCA, issued as a final rule Significant New Use Rules (SNURS) affecting two chemical substances identified as generic multi-walled and single-walled carbon nanotubes (MWCNTs and SWCNTs respectively). These SNURs are applicable to manufacturers, importers, and processors, who will be required to notify EPA at least 90 days in advance if they intend to use these substances "for a use that is designated as a significant new use by this final rule. . . . EPA believes that this action is necessary because these chemical substances may be hazardous to human health and the environment".

This final rule is the culmination of a process that has taken over a year. EPA had issued a direct final rule in the Federal Register issue of 06/24/2009. This direct final rule affected several chemical substances, including the MWCNTs and the SWCNTs, that had been the subject of various consent decrees issued by EPA. The language of the final rule affecting the MWCNTs read as follows:

Sec.  721.10155  Multi-walled carbon nanotubes (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as multi-
walled carbon nanotubes (PMN P-08-177) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec. 
721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (a)(5) (National
Institute for Occupational Safety and Health (NIOSH)-approved air-
purifying, tight-fitting full-face respirator equipped with N100
filters), (a)(6)(i), and (c).
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80 (j) and (q).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 
721.125 (a), (b), (c), (d), (e), and (i) are applicable to
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to this section.
 

The language affecting SWCNTs is the same.

Following receipt of a notice to file adverse comments, EPA withdrew the SNURs affecting MWCNTs and SWCNTs on  08/21/2009. A proposed final rule was published in the Federal Register on 11/06/2009. This proposed rule retained the language of the original direct rule while also adding new language regarding the release of the MWCNTs and SWCNTs into water. The added language is italicized and bolded below.

Sec.  721.10155  Multi-walled carbon nanotubes (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as multi-
walled carbon nanotubes (PMN P-08-177) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec. 
721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (a)(5) (National
Institute for Occupational Safety and Health (NIOSH)-approved air-
purifying, tight-fitting full-face respirator equipped with N100
filters), (a)(6)(i), and (c).
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80 (k) and (q).
    (iii) Release to water. Requirements as specified in Sec.  721.90
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 
721.125 (a), (b), (c), (d), (e), (i), and (k) are applicable to
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to this section.
 

Again, the language for SWCNTs was the same.

After receiving and reviewing comments submitted by the public about the proposed rule, EPA added more new language clarifying that the requirements of the rule didnot apply after the substances had been cured, incorporated or embedded into a polymer matrix that had been cured or is a solid that will not undergo anymore chemical processing.  Again, the added language is italicized and bolded below.

Sec.  721.10155  Multi-walled carbon nanotubes (generic).

    (a) Chemical substance and significant new uses subject to
reporting--(1) The chemical substance identified generically as multi-
walled carbon nanotubes (PMN P-08-177) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section. The requirements of this rule do not apply to
quantities of the chemical substance after it has been completely
reacted (cured); incorporated or embedded into a polymer matrix that
itself has been reacted (cured); or embedded in a permanent solid
polymer form that is not intended to undergo further processing except
for mechanical processing.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec. 
721.63(a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (a)(5) (National
Institute for Occupational Safety and Health (NIOSH)-approved air-
purifying, tightfitting full-face respirator equipped with N100
filters), (a)(6)(i), and (c).
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec.  721.80(k) and (q).
    (iii) Release to water. Requirements as specified in Sec. 
721.90(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec. 
721.125(a), (b), (c), (d), (e), (i), and (k) are applicable to
manufacturers, importers, and processors of this chemical substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec.  721.1725(b)(1) apply to this section.
 

EPA has issued these final SNURs to achieve four objectives:

EPA will receive notice of any person's intent to
manufacture, import, or process a listed chemical substance for the
described significant new use before that activity begins.
    EPA will have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing,
importing, or processing a listed chemical substance for the described
significant new use.
    EPA will be able to regulate prospective manufacturers,
importers, or processors of a listed chemical substance before the
described significant new use of that chemical substance occurs,
provided that regulation is warranted pursuant to TSCA sections 5(e),
5(f), 6, or 7.
    EPA will ensure that all manufacturers, importers, and
processors of the same chemical substance that is subject to a TSCA
section 5(e) consent order are subject to similar requirements.
 

In the review of the comments received in response to the proposed final rule, EPA specifies that these SNURs apply only to "the specific CNTs that were the subject of PMNs P-08-177 P-08-328. . . . EPA acknowledges that CNTs made by different manufacturers and processes may be considered different substances for purposes of reporting new chemical substances under TSCA. EPA will make this determination on a case-by-case basis." Other comments filed focused on what the commenters contend is the near impossibility of achieving 100% filtration of CNTs from the waste streams produced by manufacturing or processing of these substances and discharged into U.S. waters.

This rule comes into effect on 10/18/2010. To read the comments submitted and supporting materials, please go here.

EPA Proposes TSCA Inventory Reporting Modifications

In the Federal Register issue of 08/13/2010, the Environmental Protection Agency (EPA) released for public comment a proposed rule that would, if adopted, significantly change the TSCA Inventory Update Reporting (IUR).

The first part of the notice, "Supplementary Information", explains the proposed changes to 40 CFR Parts 704, 710, and 711. The text of the proposed rule follows the Supplementary Information.

In the Supplementary Information, EPA states that it is proposing modifications to the IUR

 to meet four primary goals:
    1. To tailor the information collected to better meet the Agency's
overall information needs.
    2. To increase its ability to effectively provide public access to
the information.
    3. To obtain new and updated information relating to potential
exposures to a subset of chemical substances listed on the TSCA
Inventory.
    4. To improve the usefulness of the information reported.
EPA believes that expanding the range of chemical substances for which
comprehensive information is to be reported and adjusting the specific
reported information, the method and

[[Page 49659]]

frequency of collecting the information, and CBI requirements will
accomplish these goals.

Reading the Supplemental Information reveals a fifth, unstated goal - the creation of uniform reporting standards that will provide EPA with the information it needs to "identify and take follow-up action on chemical substances that may pose potential risks to human health or the environment" in a more efficent and timely manner, cutting the amount of time EPA staff will need to spend reviewing submitted information, determining if EPA action is required and uploading the information to a publicly available databse.

Under the proposed rule, EPA would require information to be submitted via agency supplied web based application

EPA believes the proposed requirement to use e-IURweb to report
electronically would eliminate problems related to the scanning of
paper documents, incorrect chemical identities, and other errors
introduced by the submitter. These errors substantially delayed the
availability of the IUR information to both internal EPA programs, such
as the Existing Chemicals Program, and the public. . . . EPA believes the
required use of e-IURweb and CDX would reduce the reporting burden on
industry by reducing both the cost and the time required to review,
edit, and transmit data to the Agency.

The terms manufacture, manufacturer, and site  would be redefined:

with this proposal . . . manufacture would be defined . . . to mean "to manufacture, produce, or import for commercial purpose.

Also with this proposal, manufacturer would be defined . . . to mean "a person who manufactures a chemical substance. "

The term site

would be defined under the IUR
rule to mean ``a contiguous property unit. Property divided only by a
public right-of-way shall be considered one site. More than one plant
may be located on a single site.
    (a) For chemical substances manufactured under contract, i.e., by a
toll manufacturer, the site is the location where the chemical
substance is physically manufactured.
    (b) The site for an importer who imports a chemical substance
described in 40 CFR 711.5 is the U.S. site of the operating unit within
the person's organization that is directly responsible for importing
the chemical substance. The import site, in some cases, may be the
organization's headquarters in the United States. If there is no such
operating unit or headquarters in the United States, the site address
for the importer is the U.S. address of an agent acting on behalf of
the importer who is authorized to accept service of process for the
importer.
    (c) For portable manufacturing units sent out to different
locations from a single distribution center, the distribution center
shall be considered the site.''
 

The proposed rule would also modify the definitions of the terms "commercial use", consumer use" "reporting year" "submission period" and add a definition for the term "industrial function".

The method of determining if a manufacturer or importer is subject to IUR reporting would be changed:

EPA is proposing to modify the method used to determine whether a
person is subject to IUR reporting. The proposed method would be to
determine whether, for any calendar year since the last principal
reporting year, a chemical substance was manufactured (including
imported) at a site in production volumes of 25,000 lb. or greater. The
proposed method would be effective after the 2011 IUR submission
period.
 

EPA is proposing this change because of the mounting evidence that
many chemical substances, even larger volume chemical substances, often
experience wide fluctuations in manufacturing volume from year to year.
 

Chemical substances coverd by IUR reporting would be changed to exempt water, both naturally occuring and manufactured, fully exempt the polymers starch, dextrin, and maltodextrin, and making chemical substances subject to enforceable consent decrees ineligible for exemption.

Data to be reported would change as well. The company name to be reported would be the name of the parent company, including its Dunns & Bradstreet (DNB) number, the chemical name(s) supplied would be the name as listed on the TSCA Inventory, production volume of chemicals manufactured, exported and/or imported would be reported on one report rather than multiple reports. A check box, to indicate if a chemical substance is to be recycled, remanufactured, reprocessed, reused or reworked would be added.

Among other changes, EPA is proposing to revise and expand the list of industrial function categories and replace the NAICS codes with Industrial Sector Codes based on the European Union's "Guidance on information requirements and chemical safety assesment". The codes for consumer and commercial product categories would also be revised.

These lists of codes would be revised to bring them into harmony with existing codes used in Canada, to better facilitate the exchange of information between EPA and its Canadian counterpart and to serve as a model for Mexican agencies to develop an inventory of chemical substances.

Manufacturers and importers would be required to report the "total number of commercial workers likely to be exposed while using the reportable chemical substance(s):

iii. Number of commercial workers reasonably likely to be exposed.
EPA is proposing to require that submitters report the total number of
commercial workers, including those at sites not under the submitter's
control, that are reasonably likely to be exposed while using the
reportable chemical substance, with respect to each commercial use. The
approximate number of workers would be reported using the same
definitions and ranges used for manufacturing and industrial processing
and use workers required by 40 CFR 710.52(c)(3)(v) and (4)(i)(F)
(proposed 40 CFR 711.15(b)(3)(vii) and (4)(i)(F)), respectively. The
ranges are:

    Fewer than 10 workers.
    At least 10 but fewer than 25 workers.
    At least 25 but fewer than 50 workers.
    At least 50 but fewer than 100 workers.
    At least 100 but fewer than 500 workers.
    At least 500 but fewer than 1,000 workers.
    At least 1,000 but fewer than 10,000 workers.
    At least 10,000 workers.

    Information on the number of commercial workers reasonably likely
to be exposed to the reportable chemical substance would be used to
characterize the commercial population reasonably likely to be exposed
to the subject chemical substance. The population characterization is
important to the development of the overall exposure characterization.
 

Claims of "Confidential Business Information" - also known more commonly as "trade secrets" - would be required to be substantiated and claimed at the time the IUR is submitted and "should be limited only to those data elements the release of which would likely cause substantial harm to the business' competitive position. . . . EPA expects that reducing the number of CBI claims would increase the amount of information available to the public and improve the timeliness of its public availability". In a previous section, EPA noted that manufacturers would submit claims for CBI on information that was publicly available from other sources and thus was not CBI at all.

In Unit V of of the Supplemental Information, EPA requests comments on the proposed rule and various other topics, ranging from how best to use IUR data to take action on chemical substances that might pose "unreasonable risks" with particular emphasis on protecting children from exposure to harmful chemical substances to changing the reporting cycle, changes in how EPA should collect the information, and whether IUR reporting requirements should be changed to include processors as well as manufacturers and importers.

Comments must be submitted by October 12, 2010. The notice describes how comments need to be submitted. After receiving and reviewing the comments submitted, EPA hopes to publish a final rule in Spring 2011. As with any proposed rule submitted for public comment by any Federal agency, there may be a "Notice of Further Proposed Rulemaking" (NPRM) or the agency may also issue an interim rule before the final rule is published.

EPA has established a docket (EPA-HQ-OPPT-2009-0187) on www.regulations.gov  where documents referenced in the Supplemental Information and comments on the proposed rule may be found.

A shorter discussion of the proposed rule may also be found on the OMB Watch website.

EPA Releases Draft Nanomaterial Case Study: Nanoscale Silver in Disinfectant Spray

The EPA recently released a draft of its "Nanomaterial Case Study: Nanoscale Silver in Disinfectant Spray" which you can download here.  The document is 323 pages long and has 6 chapters: (i) Introduction; (ii) Introduction to Silver and Nanoscale Silver; (iii) Life-Cycle Stages; (iv) Fate and Transport in Environmental Media; (v) Exposure, Uptake, and Dose; and (vi) Characterization of Effects.

In two chapters most pertinent to our readers, the document discusses the possible EHS ramifications of the manufacturing and use of nanoscale silver disinfectants over a wide-range of issues.  Regarding Life-Cycle Stages, the document covers five primary product stages: feedstocks; manufacturing; distribution and storage; use; and disposal.  Similarly, regarding fate and transport in the environment, the document discusses air, terrestrial, and aquatic systems and factors that effect transport and fate in each media.

Overall , the document appears to mirror the approach used in EPA's prior draft case study on nanoscale titanium dioxide used in drinking water systems and in sunscreens which was published in 2009. 

Written comments on the draft are due to EPA by September 27, 2010.

 

EPA nanomaterial disclosure policy submitted to OMB for review

Inside Washington's Inside the EPA newsletter carries an article regarding the EPA's Office of Chemical Safety and Pollution Prevention submitting for review a notice outlining EPA's intention to use its existing regulatory authority under the Federal Insecticide, Fungicide & Rodenticide Act (FIFRA) to require that manufacturers of pesticides provide more information to EPA about their use of nanoscale materials in their products.

This proposed notice was discussed at a presentation by William Jordan of EPA's Office of Pesticide Programs (OPP) to the Pesticide Programs Dialogue Committee and also in a recent GAO report . The notice will also include OPP's definition of nanomaterials as ingredients containing particles between 1 and 100 nanometers in size.

During his presentation, Mr. Jordan noted that this new policy resulted from concerns expressed by the public about the potential toxic effects of nanoscale materials on the environment and humans. Industry groups and pesticide manufacturers also expressed their concern that the proposed rule could taint all nanomaterials as "adverse" and affect potential future sales of pesticides that include nanomaterials.

The text of the notice is not available from OMB's Reginfo.gov site. When it does appear in the Federal Register following OMB's review, it will be discussed and reviewed here.

EPA Reopens Comment Period for Proposed SNUR for MWCNT

In a notice published in the Federal register on July 28, 2010, the Environmental Protection Agency (EPA) announced that it was adding new information to its public docket EPA-HQ-OPPT-2009-0686 and was reopening the comment period for  a proposed Significant New Use Rule (SNUR) for multiwalled carbon nanotubes (MWCNTS) first published in the Federal Register on February 3, 2010.

The proposed rule requires "persons who intend to manufacture, import, or process the substance" - described elsewhere in the notice as "multi-walled carbon nanotubes(generic)" to "be used as an additive/filler for polymer composites and support media for industrial catalysts" - "for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity". This would give EPA time to assess "risks that may be presented by the intended uses and, if appropriate, to regulate the proposed use before it occurs."

Information regarding submission of comments will be found in the original notice of February 3, 2010.

The "Significant New Use" for the MWCNTS (generic) are described in the Feb. 3, 2010 notice as

certain changes from the use scenario described in the
PMN could result in increased exposures, thereby constituting a
``significant new use.'' EPA has determined that activities proposed as
a ``significant new use'' satisfy the two requirements stipulated in
Sec.  721.170(c)(2), i.e., these significant new use activities, ``(i)
are different from those described in the premanufacture notice for the
substance, including any amendments, deletions, and additions of
activities to the premanufacture notice, and (ii) may be accompanied by
changes in exposure or release levels that are significant in relation
to the health or environmental concerns identified'' for the PMN
substance.
 

EPA has determined, however, that use of the substance without the use of gloves and protective clothing, where there is a potential for dermal exposure;
use of the substance without a National Institute for Occupational
Safety and Health (NIOSH)-approved full-face respirator with an N100
cartridge, where there is a potential for inhalation exposure; or use
other than as described in the PMN, may cause serious health effects.
Based on this information, the PMN substance meets the concern criteria
at Sec.  721.170(b)(3)(ii).
 

Following the closing of the comment period and review of the comments received, EPA will publish summaries and EPA's replied to the submitted comments in a future issue of the Federal register, along with the final rule.