Chemical Substances When Manufactured or Processed as Nanoscale Materials; TSCA Reporting and Recordkeeping Requirements
Proposed rule.
CFR Part: "40 CFR Part 704"
RIN Number: "RIN 2070-AJ54"
Citation: "80 FR 18330"
Document Number: "EPA-HQ-OPPT-2010-0572; FRL-9920-90"
Page Number: "18330"
"Proposed Rules"
SUMMARY:
EFFECTIVE DATE: Comments must be received on or before
ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2010-0572, by one of the following methods:
* Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
* Mail: Document Control Office (7407M),
* Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture or process or intend to manufacture or process nanoscale forms of certain chemical substances. However, persons that manufacture or process, or intend to manufacture or process these chemical substances as part of articles, as impurities, or in small quantities solely for research and development would not be subject to this action. In addition, the discussion in Unit III.A. describes in more detail which chemical substances would and would not be subject to reporting under the proposed rule. You may also consult 40 CFR 704.3 and 704.5, as well as the proposed regulatory text in this document, for further information on the applicability of these and other exemptions to this proposed rule.
The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document may apply to them:
* Chemical Manufacturing or Processing (NAICS codes 325).
* Synthetic Dye and Pigment Manufacturing (NAICS code 325130).
* Other Basic Inorganic Chemical Manufacturing (NAICS code 325180).
* Rolled Steel Shape Manufacturing (NAICS code 331221).
* Semiconductor and Related Device Manufacturing (NAICS code 334413).
* Carbon and Graphite Product Manufacturing (NAICS code 335991).
* Home Furnishing Merchant Wholesalers (NAICS code 423220).
* Roofing, Sliding, and Insulation Material Merchant Wholesalers (NAICS code 423330).
*
* Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology) (NAICS code 541712).
B. What is the agency's authority for taking this action?
The Toxic Substances Control Act (TSCA), 15 U.S.C.
C. What action is the agency taking?
EPA is proposing reporting and recordkeeping requirements for persons that manufacture (including import) or process certain chemical substances as described in Unit III.A. Persons who currently manufacture or process these chemical substances as discrete nanoscale materials would be required to notify
Included in this proposal are electronic reporting requirements similar to those established in 2013 for other kinds of information:
This proposed rule and the discussion of the potential risks do not conclude and are not intended to conclude that nanoscale materials as a class, or specific uses of nanoscale materials, necessarily give rise to or are likely to cause harm to people or the environment. Rather,
EPA is not proposing to publish an inventory of chemical substances manufactured at the nanoscale based on the information that would be collected pursuant to these proposed TSCA section 8(a) reporting requirements.
D. Why is the agency taking this action?
These reporting and recordkeeping requirements would assist
Consistent with the
E. What are the estimated incremental impacts of this action?
EPA has evaluated the potential costs of establishing the proposed reporting and recordkeeping requirements for potential manufacturers and processors. This analysis (Ref. 3), which is available in the docket, is briefly summarized here.
Under the proposed rule, industry is conservatively estimated to incur a burden of approximately 206,098 hours in the first year and 22,755 hours in subsequent years, with costs of approximately
F. What should I consider as I prepare my comments for
1. Submitting CBI. Do not submit this information to
2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
II. Background
A. Overview of Applicable Authority
1. TSCA section 8(a) reporting. Section 8(a) of TSCA authorizes
Small manufacturers and processors, as defined by
General provisions for TSCA section 8(a) rules appear in 40 CFR part 704 Subpart A. These provisions describe definitions, exemptions (including for articles and research and development), confidential business information claims, and recordkeeping that apply to TSCA section 8(a) rules. For example in 40 CFR 704.3 the definition of known to or reasonably ascertainable by is defined to mean all information in a person's possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know.
In addition, the definitions in TSCA section 3 apply to this rulemaking.
2. Electronic reporting under the Government Paperwork Elimination Act (GPEA). GPEA, 44 U.S.C. 3504, provides that, when practicable, Federal organizations use electronic forms, electronic filings, and electronic signatures to conduct official business with the public.
B. Why is
There is a growing body of scientific evidence showing the differences that exist between chemical substances and chemical substances manufactured in nanoscale forms (Ref. 5). Chemical substances manufactured at the nanoscale may have different or enhanced properties--for example, electrical, chemical, magnetic, mechanical, thermal, or optical properties--or features, such as improved hardness or strength, that are highly desirable for applications in commercial, medical, military, and environmental sectors (Ref. 6). These properties are a direct consequence of decreasing size, where surface area per unit of volume increases exponentially and quantum effects may appear in the low tens of nanometers and below. Small size itself can also be a desirable property of nanoscale materials. The small size can be exploited for miniaturization of applications/processes and/or stabilization or delivery of payloads to diverse environments or incorporation into diverse products.
Nanoscale materials have a range of potentially beneficial public and commercial applications, including medicine and public health, clean energy, pollution reduction and environmental cleanup, and improved products such as stronger, lighter, and more durable or conductive materials. These benefits arise from the distinctive properties of nanoscale materials, in that they are potentially more interactive or durable than other chemical substances. Altering the size of a material from conventional particle size can enhance or produce unique properties that are desirable for a variety of commercial applications. However, these unique and enhanced properties can raise new questions, such as whether the material in the smaller form may present increased hazards to humans and the environment.
Government, academic, and private sector scientists in multiple countries are performing research into the environmental and human health effects of diverse nanoscale materials, resulting in a substantial and rapidly growing body of scientific evidence. This research also indicates that, in biological systems or in the environment, not all materials in the nanoscale size range behave differently from larger sized materials of the same substance (Ref. 7). Recently, a governmental organization and an independent scientific committee have reviewed and summarized this evidence and offered views about the implications of this evidence for environmental and human health and safety.
In 2009, the
* "Nanomaterials have the greatest potential to enter the body through the respiratory system if they are airborne and in the form of respirable-sized particles (nanoparticles). They may also come into contact with the skin or be ingested."
* "Based on results from human and animal studies, airborne nanoparticles can be inhaled and deposited in the respiratory tract; and based on animal studies, nanoparticles can enter the blood stream, and translocate to other organs."
* "Experimental studies in rats have shown that equivalent mass doses of insoluble incidental nanoparticles are more potent than large particles of similar composition in causing pulmonary inflammation and lung tumors. Results from in vitro cell culture studies with similar materials are generally supportive of the biological responses observed in animals."
* "Experimental studies in animals, cell cultures, and cell-free systems have shown that changes in the chemical composition, crystal structure, and size of particles can influence their oxidant generation properties and cytotoxicity."
* "Studies in workers exposed to aerosols of some manufactured or incidental microscopic (fine) and nanoscale (ultrafine) particles have reported adverse lung effects including lung function decrements and obstructive and fibrotic lung diseases. The implications of these studies to engineered nanoparticles, which may have different particle properties, are uncertain."
* "Some nanomaterials may initiate catalytic reactions depending on their composition and structure that would not otherwise be anticipated based on their chemical composition."
Earlier the same year, the
* "Some specific hazards, discussed in the context of risk for human health, have been identified. These include the possibility of some nanoparticles to induce protein fibrillation, the possible pathological effects caused by specific types of carbon nanotubes, the induction of genotoxicity, and size effects in terms of biodistribution."
* "For some nanomaterials, toxic effects on environmental organisms have been demonstrated, as well as the potential to transfer across environmental species, indicating a potential for bioaccumulation in species at the end of that part of the food chain."
In another survey of scientific research on nanoscale materials (Ref. 10), the authors reported:
Many studies have examined the pro-inflammatory effects of manufactured nanoparticles, on the basis that their ability to cause inflammation is a major predictor of potential hazard in such particles. The first important finding was that nanoparticles have a more pronounced effect on inflammation, cell damage and cell stimulation than an equal mass of particles of the same material of greater size. This appears to hold true for materials as varied as carbon black, titanium dioxide, various metals and polystyrene. Surface area is the metric driving the pro-inflammatory effects and this is evident both in vitro and in vivo, particles of various sizes producing inflammatory effects that are directly related to the surface area dose.
A report in the scientific literature has indicated that nanoscale polystyrene beads may cross the placental barrier (in an ex-vivo human placental perfusion model (Ref. 11). Another study found that nanoparticles could translocate to diverse organs following oral exposure in rodents. Once in these diverse sites and organs, the large surface area of nanoscale materials may facilitate increased reactivity and/or an inflammatory response, resulting in toxic effects (Ref. 12).
Two literature surveys describe a broad range of effects in non-mammalian species following exposure to nanoscale materials (Ref. 13 and 14). These include, for example, increased ventilation rates, mucus production, and pathologies, and related alteration of enzyme activities and indicators of oxidative stress in rainbow trout, Oncorhyncus mykiss (Ref. 15) and ingestion and accumulation of nanoscale material in the digestive tract, as well as mortality, increased heart rates, and reduced fecundity in Daphnia magna (Ref. 16, 17, and 18). Translocation of nanoscale materials from gill and gut surface to blood and other organs in exposed Medaka, Oryzius latipes, has also been reported (Ref. 19) and carbon nanotubes, although unable to cross the egg surface, have been shown to delay hatching in zebra fish, Danio rerio (Ref. 20).
Published reports of human and ecological exposure to nanomaterials are also limited. For example, in its "Current Intelligence Bulletin 65: Occupational Exposure to Carbon Nanotubes and Nanofibers" (Ref. 21), NIOSH summarized and evaluated the available published information on worker exposures to carbon nanotubes (CNT) and nanofibers (CNF). NIOSH determined that, although the potential for worker exposure to CNT and CNF can occur throughout the life cycle of CNT- and CNF-product use (processing, use, disposal, recycling), the extent to which workers are exposed has not been completely characterized. "Comprehensive workplace exposure evaluations are needed to characterize and quantify worker exposure to CNT and CNF at various job tasks and operations, and to determine what control measures are the most effective in reducing worker exposures." "Data are particularly needed on workplace exposures to CNT and CNF, as well as information on whether in-place exposure control measures (e.g., engineering controls) and work practices are effective in reducing worker exposures."
There are many scientific questions about the impacts of chemical substances manufactured at the nanoscale on human health and the environment. Part of
Some of the same special properties that make nanoscale materials useful are also properties that may cause some nanoscale materials to pose risks to humans and the environment, under specific conditions.
As described in the 2008 TSCA Inventory Status of Nanoscale Substances--General Approach, many nanoscale materials are considered chemical substances as defined under TSCA section 3(2) (Ref. 23). Nanoscale forms of chemical substances that are not on the TSCA Inventory in any form are considered new chemical substances that require reporting under TSCA section 5.
EPA developed a voluntary Nanoscale Materials Stewardship Program (NMSP or "the program") to complement and support its regulatory activities on chemical substances manufactured at the nanoscale.
To address some of the data needs identified in the NMSP interim report,
III. Summary of Proposed TSCA Section 8(a) Rule
EPA is proposing reporting and recordkeeping requirements for manufacturers and processors of certain chemical substances pursuant to TSCA section 8(a).
A. What chemical substances would be reportable under this rule?
1. Reportable chemical substances. This proposed rule would apply to chemical substances that are solids at 25 [degrees] C and atmospheric pressure and that are manufactured or processed in a form where the primary particles, aggregates, or agglomerates are in the size range of 1-100 nanometers (nm) and exhibit unique and novel characteristics or properties because of their size. The proposed rule would apply to chemical substances containing primary particles, aggregates, or agglomerates in the size range of 1-100 nm in at least one dimension. This proposed rule would not apply to chemical substances that only have trace amounts of primary particles, aggregates, or agglomerates in the size range of 1-100 nm, such that the chemical substance does not exhibit the unique and novel characteristics or properties because of particle size.
i. Discrete forms. Manufacturers and processors of multiple nanoscale forms of the same chemical substance would, in some cases, need to report separately for each discrete form of the reportable chemical substance.
EPA is proposing the combination of these three factors rather than simply size to distinguish between different chemical substances manufactured at the nanoscale so that unintended variation in size range between production batches would not trigger TSCA section 8(a) reporting. Also,
For the purposes of this proposed rule, specific surface area is the ratio of the surface area of the nanoscale material to its mass or the area of the surface of the nanoscale material divided by volume. This is an important factor because chemical reactions take place at the surface of the material. Thus, the higher the surface area, the greater the chemical reactivity, which is an important consideration for human health toxicity and environmental toxicity assessments. Specific surface area is the ratio of the area of the surface of a nanoscale material divided by the mass (m2/kg) or the area of the surface of the nanoscale material divided by volume (m2/m3).
Zeta potential is the electrokinetic potential in colloidal systems. It is measured as the net number of positive and negative charges per unit particle surface area in Coulomb/m2 (Ref. 25) and is typically measured by electrophoresis.
Dispersion stability is the ability of a dispersion to resist changes in properties over time and can be defined in terms of the change in one or more physical properties over a given time period. See ISO/TR 13097:2013 "Guidelines for characterization of dispersion stability" (Ref. 26) as an example.
Surface reactivity is the degree to which the nanoscale material will react with biological systems. The surface reactivity of the form of a chemical substance is dependent upon factors such as redox potential which is a measure of the tendency of an entity to lose or acquire electrons, and photocatalytic activity, including the potential to generate free radicals. Reactive oxygen species (ROS) and free radicals are important in considering toxicity for these materials.
A nanoscale form of a particular chemical substance with a different morphology or shape would also qualify as a discrete form. Examples include spheres, rods, ellipsoids, cylinders, needles, wires, fibers, cages, hollow shells, trees, flowers, rings, tori, cones, and sheets. Nanoscale forms of a particular chemical substance that are coated with different chemical substances would be considered discrete forms for each chemical coating.
ii. Chemical mixtures. Chemical substances that are manufactured or processed in a nanoscale form solely as a component of a mixture, encapsulated material, or composite would also have to be reported. Chemical substances at the nanoscale that are manufactured but are then incorporated into mixtures, encapsulated materials or composites by that manufacturer would not require separate reporting for their incorporation. However, the person reporting the chemical substance would have to report each step of its manufacture, processing and use to the extent it is known or reasonably ascertainable.
2. Substances excluded from reporting.
EPA is proposing to exclude chemical substances which dissociate completely in water to form ions that are less than 1 nanometer. This exclusion would not apply to chemical substances manufactured at the nanoscale materials that release ions but do not dissociate in water to form those ions.
EPA is proposing to exclude from the requirements of this rule nanoclays, zinc oxide and chemical substances manufactured at the nanoscale as part of a film on a surface. The Agency believes that information collected on these materials would be of limited value because either they have been well-characterized or they present little exposure potential.
3. General exemptions to TSCA Section 8(a) reporting. The general exemptions to TSCA section 8(a) reporting at 40 CFR 704.5 would be applicable to this proposed rule. This includes, among other exemptions, the exemption for research and development under which a person who manufactures or processes, a chemical substance only in small quantities for research and development would be exempt from the reporting requirements of this proposed rule. Examples of research and development (R&D) activity are the analysis of the chemical or physical characteristics, the performance, or the production characteristics of a chemical substance, a mixture containing the substance, or an article. It can include production of a chemical substance for use by others in their R&D activities. R&D activity generally includes specific monitored tests undertaken as part of a planned program of activity.
EPA is proposing an alternate exemption for the existing small manufacturer exemption. Under other TSCA section 8(a) rules, a company qualifies as a small manufacturer in 40 CFR 704.3 by meeting either of the following two standards. The first is that sales of the company are less than
EPA is proposing a different exemption for purposes of this rule by eliminating the first standard and defining a small manufacturer or processor as any company with sales of less than
4. Proposed exceptions to reporting. The proposed rule would not require manufacturers or processors to report certain information that has already been submitted to
B. When would reporting be required?
EPA proposes that persons who manufacture or process a discrete form of a reportable chemical substance at any time during the three years prior to the final effective date of the rule would report to
The 135-day period is based on
C. What information would be reported?
This TSCA section 8(a) rule proposes one-time reporting of certain information, including specific chemical identity, production volume, methods of manufacture and processing, use, exposure and release information, and available health and safety data.
EPA developed an information reporting form for the NMSP (Ref. 27) which has been slightly modified for purposes of this proposed rule. The same information that was requested in the NMSP would be required by this proposed rule, including information on specific chemical identity, material characterization, physical chemical properties, production volume, use, methods of manufacturing and processing, exposure and release information, and existing data concerning the environmental and health effects. The information would be reported on a form similar to that used in the NMSP (Ref. 27). Any person required to report under this proposed rule would supply the information identified in the form to the extent it is known to or reasonably ascertainable by them. A draft of the proposed reporting form (EPA Form No. 7710-[tbd]) is available in the docket for public review (Ref. 28).
EPA is requesting comment on whether any information proposed to be collected requested in this proposed rule is duplicative of information collected under other federal statutes and, thus should be excluded. Please identify the statute and the information that you believe is duplicative.
EPA is proposing electronic reporting similar to the requirements established in 2013 for submitting other information under TSCA (see proposed 704.20(e)).
EPA developed the Chemical Information Submission System (CISS) for use in submitting data for TSCA sections 4, 8(a), and 8(d) electronically to the Agency. The tool is available for use with Windows, Macs, Linux, and UNIX based computers, using "Extensible Markup Language" (XML) specifications for efficient data transmission across the Internet. CISS, a web-based reporting tool, provides user-friendly navigation, works with CDX to secure online communication, creates a completed Portable Document Format (PDF) for review prior to submission, and enables data, reports, and other information to be submitted easily as PDF attachments, or by other electronic standards, such as XML.
EPA is proposing to require submitters to follow the same submission procedures used for other TSCA submissions, i.e., to register with
Users who have previously registered with CDX for other TSCA submissions, Chemical Data Reporting, or the Toxic Release Inventory TRI-ME web reporting flow, would be able to add the "Submission for Chemical Safety and Pesticide Program (CSPP)" CDX flow to their current registration, and use the CISS web-based reporting tool.
All submitters would be required to use CISS to prepare their submissions. CISS guides users through a "hands-on" process of creating an electronic submission. Once a user completes the relevant data fields, attaches appropriate PDF files, or other file types, such as XML files, and completes metadata information, the web-based tool validates the submission by performing a basic error check and makes sure all the required fields and attachments are provided and complete. Further instructions on submitting voluntary submissions, such as under MOUs, are available, and instructions for uploading PDF attachments or other file types, such as XML, and completing metadata information would be available through CISS reporting guidance.
CISS, a web-based reporting tool, also allows the user to choose "Print," "Save," or "Transmit through CDX." When "Transmission through CDX" is selected, the user is asked to provide the user name and password that was created during the CDX registration process. CISS then encrypts the file and submits it via CDX. The user will login to the application and check the status of their submissions. Upon successful receipt of the submission by
EPA believes that electronic reporting reduces the reporting burden for submitters by reducing the cost and time required to review, edit, and transmit data to the Agency. It also allows submitters to share a draft submission within their organization, and more easily save a copy for their records or future use. The resource and time requirements to review and process data by the Agency will also be reduced and document storage and retrieval will require fewer resources.
Any person submitting a reporting form could claim any part or all of the form as CBI. Any information which is claimed as confidential will be disclosed by
IV. Development of Additional Data in Connection With the TSCA Section 8(a) Rule
A TSCA section 8(a) rule may require persons subject to the rule to submit test data in their possession or control and to describe any other data known to or reasonably ascertainable by them, but may not require persons to develop test data for submission to the Agency. However, in view of the lack of information regarding chemical substances manufactured at the nanoscale,
Persons choosing to develop test data should provide data that conform to the Good Laboratory Practice Standards, which are codified at 40 CFR part 792. There are also standard test methods available for properties and information identified in the proposed rule from a number of sources. Some of these sources include but are not limited to
V. Request for Comments
EPA is seeking public comment on all aspects of this proposed rule. In addition to specific requests for comment included throughout this document,
1. Identifying the chemical substances that would be subject to reporting.
2. Distinguishing between nanoscale forms of a reportable chemical substance.
3. Reporting discrete forms at least 135 days before commencement of manufacture or processing. As discussed in Unit III.B.,
4. Considerations for the Agency's economic analysis.
5. Electronic reporting. In proposing to require electronic reporting under this rule that is similar to those established in 2013 for other TSCA reporting,
6. Consideration of potential future rulemaking regarding periodic reporting.
VI. References
The following is a listing of the documents that are specifically referenced in this document. The docket includes these references and other information considered by
1. 2013.
2. 2011. Executive Office of the President. Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials. http://www.whitehouse.gov/sites/default/files/omb/inforeg/for-agencies/nanotechnology-regulation-and-oversight-principles.pdf.
3. 2015.
4. 2005.
5. 2005. Oberdoerster, Gunter, Oberdoerster, Eva, and Oberdoerster, Jan. Nanotoxicology: an emerging discipline evolving from studies of ultrafine particles. Environmental Health Perspectives. (113): 823-839.
6. 2014. National Nanotechnology Initiative (NNI). "Supplement to the President's 2015 Budget," p. 3. http://www.nano.gov/sites/default/files/pub_resource/nni_fy15_budget_supplement.pdf.
7. 2009. Auffan, Melanie, Rose, Jerome, Bottero Jean-Yves, Lowry, Gregory V Jolivet Jean-Pierre, and Wiesner, Mark R. Towards a definition of inorganic nanoparticles from an environmental, health and safety perspective. Nature Nanotechnology 4, 634-641. Published online:
8. 2009. NIOSH. Approaches to Safe Nanotechnology: Managing the Health and Safety Concerns Associated with Engineered Nanomaterials. Available on-line at http://www.cdc.gov/niosh/docs/2009-125/pdfs/2009-125.pdf.
9. 2009.
10. 2009. Seaton, Anthony, Tran, Lang, Aitken, Robert, and
11. 2010. Wick, Peter, Malek, Antoine, Manser, Pius, Meili, Danielle, Maeder-Althaus, Xenia, Diener, Liliane, Diener, Pierre-Andre, Zisch, Andreas,
12. 2008. Kim, Yong Soon, Kim,
13. 2008. Handy, Richard D.,
14. 2008. Klaine, Stephen J., Alvarez, Pedro J., Batley, Graeme E., Fernandes, Teresa F., Handy, Richard D.,
15. 2007. Federici, Gillian, Shaw, Benjamin J., and Handy, Richard D. Toxicity of titanium dioxide to rainbow trout (Oncorhynchus mykiss): Gill injury, oxidative stress, and other physiological effects. Aquatic Toxicology. 84: 415-430.
16. 2007. Roberts, Aaron P., Mount, Andrew S.,
17. 2006. Lovern, Sarah B., and Klaper, Rebecca. Daphnia magna mortality when exposed to titanium nanoparticles and fullerene (C60) nanoparticles. Environmental Toxicology and Chemistry. 25: 1132-1137.
18. 2006. Oberdoerster, Eva, Zhu, Shiqian, Zhu, Blickley,
19. 2006. Kashiwada, Shosaku. Distribution of nanoparticles in the see-through Medaka (Oryzias latipes). Environmental Health Perspectives. 114: 1697-1702.
20. 2007. Cheng, Jinping, Flahaut, Emmanuel, and Cheng, Shuk Han. Effect of carbon nanotubes on developing zebra fish (Danio rerio) embryos. Environmental Toxicology and Chemistry. 26:708-716.
21. 2013. NIOSH. Current Intelligence Bulletin 65: Occupational Exposure to Carbon Nanotubes and Nanofibers at http://www.cdc.gov/niosh/docs/2013-145/pdfs/2013-145.pdf.
22. 2007.
23. 2008.
24. 2009.
25. 2012.
26. 2013. ISO/TR. Guidelines for Characterization of Dispersion Stability. ISO/TR 13097:2013.
27. 2008.
28. 2015.
29. 2015.
VII. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review
The Office of Management and Budget (OMB) has designated this proposed rule as a "significant regulatory action" under section 3(f) of Executive Order 12866 (58 FR 51735,
B. Paperwork Reduction Act (PRA)
An agency may not conduct or sponsor, and a person is not required to respond to an information collection request subject to the PRA, 44 U.S.C. 3501 et seq., unless it displays a currently valid OMB control number. The OMB control numbers for
The information collection requirements in 40 CFR part 704 related to TSCA section 8(a) reporting rules have already been approved by OMB under the PRA. That information collection request (ICR) has been assigned EPA ICR No. 1198.10 and OMB Control No. 2070-0067. Because this proposed rule would involve revised information collection activities that require additional OMB approval,
If an entity were to submit a report to the Agency, the annual burden is estimated to average 137 hours per response. Burden is defined in 5 CFR 1320.3(b). As presented in the economic analyses and the ICR addenda,
To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden,
Since OMB is required to make a decision concerning the ICR between 30 and 60 days after
C. Regulatory Flexibility Act (RFA)
Pursuant to section 605(b) of the RFA, 5 U.S.C.
Under the RFA, small entities include small businesses, small organizations, and small governmental jurisdictions. For purposes of assessing the impacts of this proposed rule on small entities, small entity is defined as: (1) a small business, as defined by the
A small business exemption exists under TSCA section 8(a) reporting rules, at 40 CFR 704.5(f). For this action,
EPA continues to be interested in the potential impacts of this proposed rule on small entities that are not exempt from reporting and welcomes comments on issues related to such impacts.
D. Unfunded Mandates Reform Act (UMRA)
Based on
E. Executive Order 13132: Federalism
This action does not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255,
F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments
This action does not have tribal implications because it will not have any effect on tribal governments, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175 (65 FR 67249,
G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks
EPA interprets Executive Order 13045 (62 FR 19885,
H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use
This action is not a "significant energy action" as defined in Executive Order 13211 (66 FR 28355,
I. National Technology Transfer and Advancement Act (NTTAA)
Since this action does not involve any technical standards, NTTAA section 12(d), 15 U.S.C. 272 note, does not apply to this action.
J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations
This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898 (59 FR 7629,
This action does not affect the level of protection provided to human health or the environment. However, the Agency believes that the information collected under this proposed rule, if finalized, will assist
List of Subjects in 40 CFR Part 704
Environmental protection, Chemicals, Hazardous materials, Recordkeeping, and Reporting Requirements.
Dated:
Assistant Administrator,
Therefore, 40 CFR chapter I is proposed to be amended as follows:
PART 704 [AMENDED]
1. The authority citation for part 704 continues to read as follows:
Authority: 15 U.S.C. 2607(a).
2. Add
(a) Definitions. For purposes of this section the terms below are defined as follows:
An agglomerate is a collection of weakly bound particles or aggregates or mixtures of the two where the resulting external surface area is similar to the sum of the surface areas of the individual components.
An aggregate is a particle comprising strongly bonded or fused particles where the resulting external surface area may be significantly smaller than the sum of calculated surface areas of the individual components.
Central Data Exchange or CDX means
Chemical Information Submission System or CISS means
A discrete form of a reportable chemical substance differs from another form of the same reportable chemical substance in that either:
(1) The change in the reportable chemical substance is due to all of the following:
(i) There is a change in process to affect a change in size and/or a change in one or more of the properties of the reportable chemical substances identified in (iii);
(ii) There is a size variation in the mean particle size that is greater than 7 times the standard deviation of the mean particle size (+/- 7 times the standard deviation); and
(iii) There is a measured change in at least one of the following properties, zeta potential, specific surface area, dispersion stability, or surface reactivity, is greater than 7 times the standard deviation of the measured value (+/- 7 times the standard deviation);
(2) The reportable chemical substance has a different morphology. Examples of morphologies include but are not limited to sphere, rod, ellipsoid, cylinder, needle, wire, fiber, cage, hollow shell, tree, flower, ring, torus, cone, and sheet; or
(3) A reportable chemical substance that is coated with another chemical substance or mixture at the end of manufacturing or processing has a coating that consists of a different chemical substance or mixture.
The Nanoscale Materials Stewardship Program was a program conducted by
Primary particles are particles or droplets that form during manufacture of a chemical substance before aggregation or agglomerization occurs.
A reportable chemical substance is a chemical substance that is solid at 25 [degrees] C and atmospheric pressure that is manufactured or processed in a form where the primary particles, aggregates, or agglomerates are in the size range of 1-100 nm and exhibit unique and novel characteristics or properties because of their size. A reportable chemical substance does not include a chemical substance that only has trace amounts of primary particles, aggregates, or agglomerates in the size range of 1-100 nm, such that the chemical substance does not exhibit the unique and novel characteristics or properties because of particle size.
A small manufacturer or processor means any manufacturer or processor whose total annual sales, when combined with those of its parent company (if any), are less than
Specific surface area means the ratio of the area of the surface of the reportable chemical substance to its mass or volume. Specific surface area by mass is the ratio of the area of the surface of a nanoscale material divided by the mass (m2/kg) and the specific surface area by volume is the area of the surface of the reportable chemical substance divided by its volume m2/m3.
Zeta Potential is the electrokinetic potential in colloidal systems. It is measured as the net number of positive and negative charges per unit particle surface area in Coulomb/m2.
Surface reactivity means the reactivity at the surface of a reportable chemical substance. It is dependent upon factors such as redox potential, which is a measure of the tendency of a substance to lose or acquire electrons, photocatalytic activity, including the potential to generate free radicals.
(b) Persons who must report.
(1) Manufacturers and processors of a discrete form of a reportable chemical substance during the three years prior to the final effective date of the rule must report except as provided in paragraph (c) of this section.
(2) Persons who propose to manufacture or process a discrete form of a reportable chemical substance after the final effective date of the rule which was not reported under paragraph (b)(1) must report except as provided in paragraph (c) of this section.
(c) When reporting is not required.
(1) The following chemical substances are not subject to reporting under this section:
(i) Zinc oxide
(ii) Nanoclays
(iii) Chemical substances manufactured at the nanoscale as part of a film on a surface
(iv) DNA
(v) RNA
(vi) Proteins
(vii) Chemical substances which dissociate completely in water to form ions that are smaller than 1 nanometer.
(2) Persons who submitted a TSCA chemical notice under 40 CFR part 720, 721, or 723 for a reportable chemical substance on or after
(3) Section 704.5 (a) through (e) apply to reporting under this section. Small manufacturers and processors as defined in paragraph (a) of this section are exempt from reporting under this section.
(4) Persons who submitted some or all of the required information for a reportable chemical substance as part of the Nanoscale Materials Stewardship Program are not required to report the information previously submitted except where the person manufactures or processes a discrete form of the reportable chemical substance.
(d) What information to report. The following information must be reported for each discrete form of a reportable chemical substance to the extent that it is known to or reasonably ascertainable by the person reporting:
(1) The common or trade name, the specific chemical identity including the correct Chemical Abstracts (CA) Index Name and available Chemical Abstracts Service (CAS) Registry Number, and the molecular structure of each chemical substance or mixture. Information must be reported as specified in
(2) Material characteristics including particle size, morphology, and surface modifications.
(3) Physical/chemical properties.
(4) The maximum weight percentage of impurities and byproducts resulting from the manufacture, processing, use, or disposal of each chemical substance.
(5)(i) Persons described in paragraph (b)(1) of this section must report the annual production volume for the previous three years before the effective date of the final rule and an estimate of the maximum production volume for any consecutive 12-month period during the next two years of production after the final effective date of this rule.
(ii) Persons described in paragraph (b)(2) of this section must report the estimated maximum 12 month production volume and the estimated maximum production volume for any consecutive 12 month period during the first three years of production.
(iii) Estimates for paragraphs (d)(5)(i) and (ii) of this section must be on 100% chemical basis of the discrete form of the solid nanoscale material.
(6) Use information describing the category of each use by function and application, estimates of the amount manufactured or processed for each category of use, and estimates of the percentage in the formulation for each use.
(7) Detailed methods of manufacturing or processing.
(8) Exposure information with estimates of the number of individuals exposed in their places of employment, descriptions and duration of the occupational tasks that cause such exposure, descriptions and estimates of any general population or consumer exposures.
(9) Release information with estimates of the amounts released, descriptions and duration of the activities that cause such releases, and whether releases are directly to the environment or to control technology.
(10) Risk management practices describing protective equipment for individuals, engineering controls, control technologies used, any hazard warning statement, label, safety data sheet, customer training, or other information which is provided to any person who is reasonably likely to be exposed to this substance regarding protective equipment or practices for the safe handing, transport, use, or disposal of the substance.
(11) Existing data concerning the environmental and health effects.
(e) How to report. You must use CDX and the CISS tool to complete and submit the information required under this part to
(1) Reporting form. You must complete EPA Form No. 7710-xx, TSCA SEC 8(a) Reporting for Nanoscale Materials: Data Submission Form.
(2) Electronic submission. You must submit the required information to
(i) To access the CDX portal, go to https://cdx.epa.gov.
(ii) The CISS tool is accessible in CDX.
(f) When to report.
(1) Persons specified in paragraph (b)(1) of this section must report the information specified in paragraph (d) of this section within six months after the final effective date of the rule.
(2) Persons specified in paragraph (b)(2) of this section must report the information specified in paragraph (d) of this section at least 135 days before commencing manufacture or processing of the chemical substance.
(g) Recordkeeping. Any person subject to the reporting requirements of this section is subject to the recordkeeping requirements in
(h) Confidential business information. Persons submitting a notice under this rule are subject to the requirements for confidential business information claims in
[FR Doc. 2015-07497 Filed 4-3-15;
BILLING CODE 6560-50-P
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