Silver Nanoparticles: NIOSH Seeks Information and Comment

Today's Federal Register carries a notice from the National Institute for Occupational Health and Safety (NIOSH) requesting information and comments regarding silver nanoparticles. NIOSH

has initiated an evaluation of the scientific data on silver nanoparticles
(AgNPs) to ascertain the potential health risks to workers and to
identify gaps in knowledge so that appropriate laboratory and field
research studies can be conducted. . . .

. . . gathering data to determine whether a
health risk to workers may exist from exposure to AgNPs and if specific
risk management guidance is needed to prevent exposure. . . .
 

Information is particularly needed for determining the relevance
of bile duct hyperplasia and hepatocellular necrosis observed in AgNP
exposed rats, as well as information on: (1) Sources of AgNP exposure,
(2) factors that influence worker's exposure, (3) in-place exposure
control measures (e.g., engineering controls) and work practices that
are effective in reducing worker exposures, and (4) appropriate
measurement methods and exposure metrics for characterizing workplace
exposures. . . .

Examples of requested
information include the following:
    (1) Identification of industries or occupations in which exposures
to AgNPs may occur.
    (2) Trends in the production and use of AgNPs.
    (3) Description of work tasks and scenarios with a potential for
exposure to AgNPs.
    (4) Workplace exposure measurement data in various types of
industries and jobs.
    (5) Case reports or other health information demonstrating
potential health effects in workers exposed to AgNPs.
    (6) Research findings from in vitro and in vivo toxicity studies,
including physical-chemical characterization of AgNPs.
    (7) Information on control measures (e.g., engineering controls,
work practices, PPE) being taken to minimize worker exposure to AgNPs.
    (8) Information on measurement methods and exposure metrics that
can be used to quantify worker exposure to AgNPs including information
on the limitations of those methods in quantifying exposures?

 

Information submitted my include "published and unpublished reports and research findings".

"All information received in response to this notice must include the agency name and docket number (CDC-2012-0014; NIOSH-260)".  and may be submitted either online via Regulations.gov - instructions on how to submit are available on the website - or by mail to 

NIOSH Docket Office,

Robert A. Taft Laboratories,
MS-C34

4676 Columbia Parkway, Cincinnati, OH 45226.

 

Comments and information submitted will be posted to the docket on Regulations.gov. The deadline for submitting either comments or information is February 19, 2013.

NIOSH has compiled a listing of relevant publications regarding AgNPS, "Evaluation of the Scientific Data on Silver Nanoparticles (AgNPS)" and will be posting that listing to the docket on Regulations.gov. Several studies of silver nanoparticles are listed as references in the notice and presumable compose the bulk of the listing. This posting will be updated when the list is available.

For further information please contact

Ralph Zumwalde, NIOSH,

MS-C14,

Robert  A. Taft Laboratories,

4676 Columbia Parkway, Cincinnati, Ohio 45226,
telephone (513) 533-8320

or Eileen Kuempel, telephone (513) 533-8363

UPDATE:

"Evaluation of the Scientific Data on Silver Nanoparticles (AgNPS)" has been posted to the docket on Regulations.gov.

International Center for Technology Assessment et al v. Hamburg

On December 21, 2011, the International Center for Technology Assessment (ICTA), along with fellow plaintiffs Friends of the Earth (FOE), the Center for Environmental Health, Food and Water Watch, the Institute for Agriculture and Trade Policy, and the Action Group on Erosion, Technology and Concentration filed a complaint in the US District Court for the District of Norther California against Margaret A. Hamburg, Commissioner of the US Food and Drug Administration (FDA), requesting that "this Court enter an Order:

 

(1) Declaring that the Defendants have violated the Administrative Procedure Act by failing to respond to the 2006 Petition within a reasonable time;

(2) Declaring that the Defendants continue to be in violation of the Administrative Procedure Act by failing to respond to the 2006 Petition;

(3) Ordering Defendants to respond to the 2006 Petition as soon as reasonably practicable"

In May of 2006, ICTA filed a "Petition Requesting FDA Amend Its Regulations for Products Composed of Engineered Nanoparticles Generally and Sunscreen Drug Products Composed of Engineered Nanoparticles Specifically". The petition requested "that the Commissioner undertake the following actions with regards to all nanomaterial products:

1) Amend FDA regulations to include nanotechnology definitions necessary to properly regulate nanomaterial products . . . .

2) Issue a formal advisory opinion explaining FDA's position regarding engineered nanoparticles in products regulated by FDA.

3) Enact new regulations directed at FDA oversight of nanomaterial products establishing and requiring . . .that: nanoparticles be treated as new substances; nanomaterials be subjected to nano-spefic paradigms of health and safety testing; and that nanomaterial products be labeled to delineate all nanoparticle ingredients

4) Any currently existing or future regulatory FDA programs for nanomaterial products must comply with the requirements of the National Environmental Policy Act (NEPA) including . . . that FDA conduct a Programmatic Environmental Impact Statement (PEIS) reviewing the impacts of nanomaterial products on human health and the environment.

Petitioners request that the Commissioner undertake the following actions with regard to nanomaterial sunscreen drug products:

5) Reopen the Administrative Record of the Final Over the Counter (OTC) Sunscreen Drug Product Monograph for the purpose of considering and analyzing information on engineered nanoparticles of zinc oxide and titanium dioxide currently used in sunscreens.

6) Amend the OTC Sunscreen Drug Monograph to address engineered nanoparticles, instructing that sunscreen products containing engineered nanoparticles are not covered under the Mongraph and instead are "new drugs" for which manufacturers must complete a New Drug Application. . . .

7) Declare all currently available sunscreen drug products containing engineered nanoparticles of zinx oxide and titanium dioxide as an imminent hazard to public health and order entities using the nanoparticles in sunscreens regulated by FDA to cease manufacture until FDA's Sunscreen Drug Monograph is finalized and FDA nanotechnology regulations are developed and implemented.

8) Request a recall from manufacturers of all pulically available sunscreen drug products containing engineered nanoparticles of titatium dioxide and/or zinc oxide until the manufacturers . . .complete new drug applications, those applications are approved by the agency, and the manufactureres otherwise comply with FDA's relevant nanomaterial product testing regulations.

FDA held open meetings and established docket FDA -2006-P-0213 (two versions of this docket exist, on Regulations.gov and on the FDA's site). Comments were filed by various stakeholders between 2006 and 2009. Many of these comments, such as those submitted by Purest Colloids Inc and the Cosmetic, Toiletry and Fragrance Association (CFTA) severly criticized the ITCA's petition and urged the FDA not to take the actions requested in the petition.

In an interim response dated Nov. 9, 2006, Randall W. Lutter, then the FDA's Associate Commissioner for Policy and Planning noted that the

. . .FDA has been unable to reach a decision on your petition because it raises complex issues requiring extensive review and analysis by agency officials. . . . We will respond to your petition as soon as we have reached a decision on your requests.

Almost six years later, FDA is still in the process of formulating regulations and policy affecting nanotechnology and nanoindustry.

The parties in the case have been referred by the US Distirct Court to Alternative Dispute Resolution. We will continue to monitor the case and update as warranted.

UPDATE:

The parties in International Center for Technology Assessment et al v Hamburg, in a stipulation filed with the court on January 13, 2012, agreed  to grant the EPA " an extension of time to April 23, 2012 to answer, move, or otherwise respond to the complaint". EPA requested the extension "because defendent is working in good faith to respond to the citizen petition . . .on or before April 23, 2012."

As before, we'll keep monitoring and updating as warranted.

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 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.