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 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 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.

GAO Provides Recommendations Regarding EPA's Effort to Regulate Nanomaterials

On Friday, the United States Government Accountability Office issued its Report to the Chairman (Barbara Boxer) of the Committee on Environment and Public Works, US Senate, GAO-10-549:

Nanotechnology: Nanomaterials Are Widely used in Commerce, but EPA Faces Challenges in Regulating Risk.

Highlights from the report follow.  The report confirms speculation that EPA intends to issue certain new rules pertaining to select nanomaterials by the end of 2010.

Background

"EPA has taken a mulitpronged approach to understanding and regulating the risks of nanomaterials, including conducting further research and implementing a voluntary data collection program. Furthermore, under its existing statutory framework, EPA has regulated some nanomaterials but not others. Although the EPA is planning to issue additional regulations later this year, these changes have not yet gone into effect and products may be entering into the market without EPA review of all available information on their potential risk. Moreover, EPA faces challenges in effectively regulating nanomaterials that may be released in air, water, and waste because it lacks the technology to monitor and characterize these materials or the statutes include volume based regulatory thresholds that may be too high for effectively regulating the production and disposal of nanomaterials."

TSCA

"In the fall of 2009, EPA announced it would reconsider the policy described in its January 2008 document, TSCA Inventory Status of Nanoscale Substances -- General Approach, and subsequently announced it planned to develop a SNUR to regulate nanoscale versions of conventional scaled chemicals that are already on the TSCA inventory as a significant new use of that chemical. The agency intends to propose this rule in December 2010."

"TSCA also gives EPA authority to issue rules requiring companies to submit certain information about chemicals. EPA plans to issue one such rule for nanomaterials that would require manufacturers to provide information on production volume, methods of manufacture and processing, and exposure and release, as well as available health and safety studies. Evaluation of this information will provide EPA with an opportunity to consider appropriate action under TSCA to reduce unreasonable risks to human health or the environment, according to EPA. This rule may also help them collect information on nanomaterials not covered by the SNUR discussed above. EPA intends to propose this rule in December 2010."

"EPA officials told us they intend to propose a rule in December 2010 that would require companies to generate test data on the health effects of 15 to 20 different nanomaterials, including carbon nanotubes, nanoclays, and nano aluminum, and also on nanomaterials used in aerosol-applied products. This information will help EPA correlate the properties of these materials with specific health effects, manage or minimize risk and exposure, and help EPA determine the need for additional testing of these materials, according to EPA. EPA officials told us they will be working with the National Institute for Safety and Health Administration, and the Consumer Product Safety Commission on this effort."

FIFRA

"EPA officials told us that if a company replaces a conventionally sized active ingredient in a pesticide with a nanoscale version of that ingredient, it is mandatory for the company to amend its registration. Officials also noted, however, that the agency's position on this point needs to be made explicit to the regulated community and such a clarification could be made in EPA guidance. According to stakeholders, manufacturers of nanopesticides are required to obtain an amended registration in such a circumstance even without new EPA guidance explicitly requiring it since the registration requirement is based not only on questions of chemical identity, but also on claims made about the pesticide; its composition; and its chemistry, toxicology, and other information."

GAO's Recommendations

"We recommend that the Administrator of EPA, take the following three actions:

  • Complete its plan to issue a Significant New Use rule for nanomaterials.
  • Modify FIFRA pesticide registration guidelines to require applicants to identify nanomaterial ingredients in pesticides.
  • Complete its plan to clarify that nanoscale ingredients in already registered pesticides, as well as in those products for which registration is being sought, are to be reported to EPA and that EPA will consider nanoscale ingredients to be new.

In addition, the Administrator of EPA should make greater use of the agency's authorities to gather information under existing environmental statutes. Specifically, EPA should

  • complete its plan to use data gathering and testing authorities under TSCA to gather information on nanomaterials, including production volumes, methods of manufacture and processing, exposure and release, as well as available health and safety studies; and
  • use information-gathering provisions of the Clean Water Act to collect information about potential discharges containing nanomaterials.

Finally, the Administrator of EPA should consider revising the Inventory Update under TSCA so that it will capture information on the production and use of nanomaterials and so that the agency will receive periodic updates on this material."

EPA's May 4, 2010 Response to GAO

Finally, attached as an exhibit to the report was a written response from EPA in which the agency largely agreed with all of GAO's recommendations. Regarding GAO's Clean Water Act recommendation, EPA stated that its Office of Research and Development is currently developing methods to detect nanomaterials in water and predict levels of concern. Once able to detect and measure nanomaterials in water, EPA will then consider whether reporting requirements should be amended.

We will continue to monitor these issues and provide timely updates to our readers.

Silver Research Consortium LLC Objects to the Environmental Protection Agency's Proposed Interpretation of Nanomaterials Under the Federal Insecticide, Fungicide, and Rodenticide Act

 

The Silver Technology Working Group (“SNWG”) of the Silver Research Consortium LLC recently sent a letter to the Environmental Protection Agency (“EPA”) expressing concern about a proposed interpretation issued by the EPA’s Office of Pesticide Programs (“OPP”) of a nanoscale pesticide products regulation under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”), 7 U.S.C. § 136 et seq. (1996). SNWG contended that the pending Federal Register policy applicable to nanotechnology constituted a damaging change which could threaten all nano-related industries. Specifically, SNWG argued that the OPP’s new interpretation would: (1) establish a definition of “nanomaterial” that arbitrarily provides a size limit of 100 nm, “focus[ing] too heavily on size rather than the underlying properties of the…material;  (2) consider the presence of any nanoscale material in any registered pesticide to be reportable as having an unreasonable adverse effect, a proposition which contradicts the articulated purpose of FIFRA §6(a)(2); and (3) erroneously declares nanosilver and all other products containing nanomaterials to be “new” materials, even though, as SNWG contends, nanosilver materials allegedly have “decades of historical records of safe use.” SNWG further noted that these policy changes could stifle innovation and progress in the nanotechnology field, as well as create an unjustifiable and negative public perception of the technology. 

EPA Set to Rule on FIFRA Nanosilver Petition in June

Inside EPA reports today that a "senior policy adviser for EPA's Office of Pesticide Programs, said EPA would issue in June a long-awaited response to a 2008 activist petition asking the agency to regulate nanoscale silver under FIFRA."  The article also mentions that EPA intends to define nanoscale ingredients for FIFRA purposes as "an ingredient that contains particles that have been intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers."

EPA Takes Aim at Anitmicrobial Products Under FIFRA

In this article, we note a couple of recent EPA enforcement actions against manufacturers allegedly making unsubstantiated antimicrobial claims for their products – much like occurred in the IOGEAR computer keyboard/mice episode in 2008.  Although these products do not purport to use nanoscale materials, the alleged claims for these products are similar to those made by manufacturers for certain nano-based antimicrobial products. Thus, our readers may be interested in EPA’s actions.

The EPA issued a press release today stating that the parent company of North Face camping and outdoor gear faces up to $1,000,000 in fines for allegedly making unsubstantiated health-related claims for almost 70 of its shoe products using Agion silver ion technology. The EPA press release states:

“At issue were more than 70 styles of footwear that incorporated an AgION silver treated footbed. The company sold the products making unsubstantiated claims that the footwear would prevent disease-causing bacteria. Specifically, The North Face made the following public health claims about the footwear on-line and on product packaging:  • ‘AgION antimicrobial silver agent inhibits the growth of disease-causing bacteria’ • ‘Prevents bacterial and fungal growth’ • Continuous release of antimicrobial agents”

The fines are being sought by EPA under the Federal Insecticide Fungicide and Rodenticide Act which prohibits unsubstantiated public health claims regarding unregistered products.

From Agion’s website: “Agion technology operates at the surface of a product through the controlled release of silver ions which attack microbes and inhibit their growth in three different ways. We offer a variety of silver-based technologies to suit various manufacturing and product requirements.” 

In another press release, EPA publicized a complaint it filed “against Peoria, Ariz.-based Granite Marketing, Inc. for the alleged sale and distribution of an unregistered pesticide in violation of the Federal Insecticide, Fungicide and Rodenticide Act. The EPA is seeking up to $5,200 in civil penalties from Granite Marketing, Inc., located at 8190 W. Deer Valley Road, for offering for sale the unregistered antimicrobial pesticide known as Titania Antibacterial System.”


 

EPA Scientific Advisory Panel to Discuss Nanoscale Silver at Public Meeting

A much valued contributor from CyberRegs provided us with the following information from the Federal Register that may be of interest to readers:

There will be a 4-day consultation meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to consider and review a set of scientific issues related to the assessment of hazard and exposure associated with nanosilver and other nanometal pesticide products.

DATES: The consultation meeting will be held on November 3 - 6, 2009, from approximately 8:30 a.m. to 5:00 p.m. The consultation meeting will be held at the Environmental Protection Agency, Conference Center, Lobby Level, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA 22202.

Comments. The Agency encourages that written comments be submitted by October 20, 2009 and requests for oral comments be submitted by October 27, 2009. Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

FOR FURTHER INFORMATION CONTACT: Joseph E. Bailey, DFO, Office of Science Coordination and Policy (7201M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 564-2045; fax number: (202) 564-8382; e-mail address:
bailey.joseph@epa.gov.

 

 

Interesting Nano-Regulatory Developments

Inside U.S. Trade reports three interesting nano-regulatory developments: (i) the "EPA has signaled that it may soon decide to regulate nano-silver as a pesticide under " FIFRA; (ii) the "EPA may rule favorably on some points" raised in the 2008 citizen's petition filed by 14 advocacy groups seeking more restrictive regulation of nanoscale silver; and (iii) Congresswoman Kathy DahlKemper (D-Pa) on the House Science and Technology Committee "is pursuing a Cosmetics Safety Bill that would require registration of cosmetics containing nanomaterials."

Nanosilver--In Case You Forgot

An article by Barnaby Feder in this morning's New York Times reminds us of a question that, even a year later, has not been completely resolved.  Astute readers (and by "astute" I mean everyone who wasn't under a rock) will remember the large discussion over the use of nanosilver as an anti-bacterial device, including the Samsung Silvercare washing machines.  Well, its back, or rather, never really left.

This morning, Mr. Feder tells the story of an interesting little device called The Handler.  In short, its a key-chain hook that is coated with nanosilver in order to stay microbe free while allowing one to handle germ covered surfaces, like handles in public restrooms.  Its fun to flip them open and closed, and I even have one (albeit for demonstration purposes only).  The Handler's manufacturers have run into the same problem as Samsung--marketing a product as anti-microbial runs afoul of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) without prior registration.  These aren't the only products making such claims (for a specific example see the earlier post on the Seal Shield keyboard and mouse).

Correctly, Mr. Feder refocuses our prior discussion on what happens to these products while the EPA determines how best to regulate them.  In this case, The Handler's production has been suspended while the owners figure out what is required of them.  In other cases, the anti-microbial claims were dropped altogether--case in point, no where on the Seal Shield box is an anti-microbial claim.  Its implied, I believe, by the use of the phrase "infection control" and quotes from physicians using the words "disinfected" or "harmful bacteria," but nowhere does it make claims that it will kill the microbes or bacteria.  And Samsung?  Mr. Feder tells us that they were allowed to continue sales of the Silvercare machine while it developed the necessary registration paperwork.

It is unclear when The Handler will again be available for purchase in the United States, but this will not be the last product impacted by such uncertainty.  Is this cause for alarm or a rush to regulation?  No, but it shows the need to continually evaluate the science and data available in order to properly mitigate risks as they are presented.  One, ok two, final questions are again raised in my mind: are existing laws and regulations suitable to address the unique realities of nanotechnology?  While existing laws seem to be serving as a suitable "stop-gap" during this period of uncertainty, how long will those measure be sufficient in order to properly treat these new products and uses without unnecessarily endangering the public or unnecessarily stifling the development of such a promising technology?