[Federal Register: November 18, 2009 (Volume 74, Number 221)]
[Notices]
[Page 59536-59537]
[DOCID:fr18no09-39]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-0184; FRL-8795[dash]5]

Pesticide Product; Registration Applications for a New Active
Ingredient Flutriafol

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces receipt of applications to register
pesticide products containing new active ingredients not included in
any currently registered products pursuant to the provisions of section
3(c)(4) of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), as amended.

DATES: Comments must be received on or before December 18, 2009.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2009-0184, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     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<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2009-0184. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT:  Tamue L. Gibson, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions

or organize comments by referencing a Code of Federal Regulations (CFR)
part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Registration Applications

    EPA received applications as follows to register pesticide products
containing active ingredients not included in any previously registered
products pursuant to the provision of section 3(c)(4) of FIFRA. Notice
of receipt of these applications does not imply a decision by the
Agency on the applications.
    1. File Symbol: 4787-LL. Applicant: Cheminova A/S, c/o Cheminova,
Inc., 1600 Wilson Blvd., Suite 700, Arlington, VA 22209. Product name:
Cheminova Flutriafol Technical. Active ingredient: Flutriafol at 80%.
Proposal classification/Use: None. For the manufacturing use
formulation into end-use products for foliar use on soybeans to control
soybean rust and on apples to control scab and powdery mildew.
    2. File Symbol: 67760-TL. Applicant: Cheminova A/S, c/o Cheminova,
Inc. Product name: Topguard Fungicide. Active ingredient: Flutriafol at
11.80%. Proposal classification/Use: None. For foliar use on soybeans
to control soybean rust and on apples to control scab and powdery
mildew.

List of Subjects

    Environmental protection, Pesticides and pest.

    Dated: November 2, 2009.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

[FR Doc. E9-27307 Filed 11-17-09; 8:45 am]

BILLING CODE 6560-50-S


EO 12866/13563 Review Draft  -  Revisions 11/21/2014
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Rin2070-AJ91_EO12866_TDI SNUR_NPRM_FR Document_Redlined_2014-11-21.docx
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                                                         BILLING CODE 6560-50-P
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2011-0976; FRL-9915-62]
RIN 2070-AJ91
Toluene Diisocyanates (TDI) and Related Compounds; Significant New Use Rule
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
SUMMARY: Under the Toxic Substance Control Act (TSCA), EPA is proposing a significant new use rule (SNUR) for 2,4-toluene diisocyanate, 2,6-toluene diisocyanate, toluene diisocyanate unspecified isomers (these three chemical substances are hereafter referred to as toluene diisocyanates or TDI) and related compounds as identified in this proposed rule. The proposed significant new use is any use in a consumer product, with a proposed exception for use of certain chemical substances in coatings, elastomers, adhesives, binders, and sealants that results in less than or equal to 0.1 percent by weight of TDI in a consumer product. In addition, EPA is also proposing that the general SNUR article exemption for persons who import or process these chemical substances as part of an article would not apply. Persons subject to the SNUR would be required to notify EPA at least 90 days before commencing any manufacturing or processing. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary based on the information available at that time, an opportunity to protect against potential unreasonable risks, if any, from that activity before it occurs.
DATES: Comments must be received on or before [insert date 60 days after date of publication in the Federal Register].
ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2011-0976, by one of the following methods:
	:: Federal eRulemaking Portal: http://www.regulations.gov.  Follow the online 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), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
	:: 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: Katherine Sleasman, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC  20460-0001; telephone number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
	For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554 - 1404; e-mail address<EMAIL_ADDRESS>SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this Action Apply to Me?
	You may be potentially affected by this action if you manufacture, process, or distribute in commerce chemical substances and mixtures. 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 applies to them. Potentially affected entities may include:
	:: Chemical and Allied Products Manufacturers (NAICS code 32411).
	:: Petroleum Refining (NAICS code 325 and 32411).
	:: Paints, coatings and adhesives manufacturing (NAICS code 3255).
	:: Urethane and other foam product manufacturing (NAICS code 326150).
	:: Transportation polyurethane foam products (NAICS code 32615011).
	:: Building and construction polyurethane foam products (NAICS code 32615031).
	:: Products made of foam other than polystyrene or polyurethane (NAICS code 32615091).
	:: All other miscellaneous polyurethane foam products (NAICS code 32615061).
	:: Consumer and institutional polyurethane foam products (NAICS code 32615051).
	:: Packing polyurethane foam products (NAICS code 32615021).
	:: Elastomers (NAICS code 326199).
	This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA.  Persons who import any chemical substance governed by a final SNUR are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements and the corresponding regulations at 19 CFR 12.118 through 12.127; see also 19 CFR 127.28.  Those persons must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA, including any SNUR requirements.  The EPA policy in support of import certification appears at 40 CFR part 707, subpart B.  In addition, any persons who export or intend to export a chemical substance that is the subject of this proposed rule on or after [insert date 30 days after the date of publication in the Federal Register are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)), (see 40 CFR 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.
      If you have any questions regarding the applicability of this action to a particular entity, consult the technical information contact listed under FOR FURTHER INFORMATION CONTACT.
B. What Is the Agency's Authority for Taking this Action?
      	Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a "significant new use."  EPA must make this determination by rule after considering all relevant factors, including those listed in TSCA section 5(a)(2).  Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture  or process the chemical substance for that use (15 U.S.C. 2604(a)(1)(B)).  As described in Unit V., the general SNUR provisions are found at 40 CFR part 721, subpart A.
C. What Action Is the Agency Taking?
	 EPA is proposing a SNUR for 2,4-toluene diisocyanate, 2,6-toluene diisocyanate, toluene diisocyanate unspecified isomers (these three chemical substances are hereafter referred to as toluene diisocyanates or TDI) and related compounds. The proposed significant new use is: Any use in a consumer product of any chemical substance listed in Table 1 of Unit II.A.; and any use in a consumer product of any chemical listed in Table 2 of Unit II.A. (except for use in coatings, elastomers, adhesives, binders, and sealants that results in less than or equal to 0.1 percent by weight of TDI in a consumer product).
      This proposed significant new use rule would apply to the uses EPA has identified in this unit that EPA believes are not ongoing at the time of this proposed rule. EPA is requesting public comment on this proposal, and specifically on the Agency's understanding of ongoing uses for the chemicals identified in Table 1 of Unit II.A and Table  2 of Unit II.A. in consumer products.  EPA is particularly interested in whether there are any ongoing uses of these chemicals in consumer products of which the Agency is currently unaware and would welcome specific documentation of any such ongoing uses.  A consumer product is defined at 40 CFR 721.3 as: a chemical substance that is directly, or as part of a mixture, sold or made available to consumers for their use in or around a permanent or temporary household or residence, in or around a school, or in recreational settings.
      This proposed SNUR would require persons that manufacture (including import) or process any of the chemicals for a significant new use, consistent with the requirements at 40 CFR 721.25, to notify EPA at least 90 days before commencing such manufacture or process of the chemical substance for a significant new use. For this proposed rule, EPA is proposing that the general SNUR article exemption at 40 CFR 721.45(f) for persons who import or process chemical substances as part of an article would not apply. The article exemption at 40 CFR 721.45(f) is based on an assumption that people and the environment will generally not be exposed to chemical substances in articles (see September 5, 1984; 49 FR 35014; FRL-2541-8 ) (Ref. 1). However, TDI and related compounds are volatile and as such could migrate out of articles that contain them.  For instance, studies of TDI in polyurethane products reported that after the reaction between an isocyanate and an alcohol to form polyurethane products, residual levels of isocyanates were detected on the surface of the products (e.g. flexible foams), which if used could lead to exposure (Refs. 2 and 3).  Because TDI and related compounds are known to be volatile chemical substances, have been reported to migrate from products, are sensitizers, and would be expected to present a higher potential for exposure if the TDI in the article were a consumer product, EPA would like the opportunity to evaluate such potential uses in consumer products for any associated risks or hazards that might exist before those uses would begin.
D. Why Is the Agency Taking this Action?
	These SNURs are necessary to ensure that EPA receives timely advance notice of any future manufacturing and processing of TDI and related compounds for new uses that may produce changes in human and environmental exposures. The rationale and objectives for this SNUR are explained in Unit III.
E. What are the Estimated Incremental Impacts of this Action?
      EPA has evaluated the potential costs of establishing SNUR reporting requirements for potential manufacturers and processors of the chemical substances included in this proposed rule. This analysis, which is available in the docket, is discussed in Unit IX., and is briefly summarized here. In the event that a SNUN is submitted, costs are estimated to be $8,589 per SNUN submission for large business submitters and $6,189 for small business submitters. These estimates include the cost to prepare and submit the SNUN and the payment of a user fee. The proposed SNUR would require first-time submitters of any TSCA section 5 notice to register their company and key users with the CDX reporting tool, deliver a CDX electronic signature to EPA, and establish and use a Pay.gov E-payment account before they may submit a SNUN, for a cost of $200 per firm. However, these activities are only required of first-time submitters of section 5 notices. In addition, for persons exporting a substance that is the subject of a SNUR, a one-time notice must be provided for the first export or intended export to a particular country, which is estimated to be $84.22 per notification. The rule may also affect firms that plan to import or process articles that contain TDI and related compounds, because, while not required by the SNUR, these parties may take additional steps to determine whether TDI and related compounds are part of the articles that they are considering to import or process. Since EPA is unable to predict whether anyone might engage in future activities that would require reporting, potential total costs were not estimated.
II. Chemical Substances Subject to this Proposed Rule
   A.    What Chemicals Are Included in the Proposed SNUR?
This proposed SNUR would apply to TDI and its related compounds listed in Table 1 of this unit and Table 2 of this unit in consumer products. Diisocyanates contain free isocyanate functional groups (-N=C=O). Diisocyanates are combined with other compounds that contain free hydroxyl functional groups (i.e.,  - OH), typically called "polyols." These two-part components react and begin to form polyurethane polymers. This chemical reaction is completed when all of the isocyanate functional groups are bound within the polymer network. This process is commonly referred to as "curing." Products that contain free isocyanate functional groups are intended to react further and undergo "curing" in the process of use. The chemical substances subject to this proposed SNUR contain free isocyanate functional groups and are by definition uncured. Prior to complete curing, consumers and bystanders can potentially be exposed to isocyanates through both dermal and respiratory routes. Exposures to uncured isocyanates could lead to sensitization.
      To ascertain if TDI and related compounds are used in consumer products, EPA reviewed published literature, the most recent data from EPA's Chemical Data Reporting program (CDR), and communicated directly with manufacturers and processors. Reporting under the CDR indicated no consumer uses of TDI or related compounds.  However, during conversations between EPA personnel and manufacturers and processors, it was revealed that in some cases consumer products may still contain residual TDI of no more than 0.1 percent by weight, as noted in Table 2 of this unit (Ref. 4). This was also confirmed by review of published literature and SDS for consumer adhesives and sealants available in retail outlets. It is EPA's understanding that any TDI present in a coating, adhesive, elastomer, binder or sealant consumer product is at levels of no more than 0.1 percent by weight and would typically be considered residual diisocyanate remaining from the manufacture of a polyurethane polymer, a concentration which is above the detection level (Ref. 5). EPA believes that other consumer products do not contain TDI or related compounds at any level.
Table 1  -  Toluene Diisocyanate Related Compounds Subject to this Action with a Proposed Significant New Use of "Any Use in a Consumer Product"

Chemical Name
Chemical Abstracts Index Name
Chemical Abstracts Service Registry Number (CASRN)
Toluene diisocyanate trimer
Benzene, 1,3-diisocyanatomethyl-, trimer
9019-85-6
Poly(toluene diisocyanate)
Benzene, 1,3-diisocyanatomethyl-, homopolymer
9017-01-0
Toluene diisocyanate dimer
1,3-Diazetidine-2,4-dione, 1,3 - bis(3-isocyanatomethylphenyl)-
26747-90-0

Toluene diisocyanate "cyclic" trimer
1,3,5-Triazine-2,4,6(1H,3H,5H) - trione, 1,3,5-tris(3 - isocyanatomethylphenyl)-
26603-40-7

Table 2  -  Toluene Diisocyanates Subject to this Action with a Proposed Significant Use of "Any Use in A Consumer Product (Except for use in Coatings, Adhesives, Elastomers, Binders, and Sealants at Less than or Equal to 0.1 Percent in a Consumer Product)"

Chemical Name
Chemical Abstracts Index Name
Chemical Abstracts Service Registry Number (CASRN)
2,6-Toluene diisocyanate
Benzene, 1,3-diisocyanato-2-methyl-
91-08-7
2,4-Toluene diisocyanate
Benzene, 2,4-diisocyanato-1-methyl-
584-84-9
Toluene diisocyanate unspecified isomer
Benzene, 1,3-diisocyanatomethyl-
26471-62-5

   B.    What Are the Production Volumes and Uses of TDI and Related Compounds?
      TDI and the related compounds are generally high production volume chemicals, predominantly used in the production of polyurethanes. There are many types of polyurethane products in the marketplace, with foams representing the largest sector of the polyurethane industry. Flexible foam is primarily used for cushioning, while rigid foam is used mainly for insulation (Ref. 6). Approximately 90 percent of TDI, typically a mixture of toluene diisocyanate isomers, is used in the production of flexible foams, which are designed to be fully cured in a final product. Non-foam polyurethane use sectors of TDI include coatings, adhesives, elastomers, binders, and sealants. These products may be sold and used, most often in a mixture of formulated product, in an uncured form. Because of its hazards, some industry representatives assert that TDI is used in products intended for industrial use only (Ref. 7). In contrast, EPA believes coatings, adhesives, elastomers, binders, and sealants used by general consumers contain residual TDI of no more than 0.1 percent by weight. Due to the projected growth of the market for such use in consumer products as discussed further in Unit II.D., EPA is concerned that consumer products in the future might contain amounts of TDI above these levels. Therefore, EPA is proposing this action to provide the Agency with an opportunity to evaluate such potential uses in consumer products for any associated risks or hazards that might exist before those uses would begin.
   C.    What Are the Potential Health Effects of TDI and Related Compounds?
      In acute, subacute, and chronic animal exposure studies for TDI, the respiratory tract was the target organ, with nasal irritation evident at concentrations above 0.1 ppm and effects becoming more severe with increasing concentration (Ref. 8). TDI is uniformly distributed throughout the body, following inhalation exposure (Refs. 8 and 9). TDI causes skin, eye, and lung irritation, progressive impairment of lung function with long-term inhalation exposure and is a respiratory sensitizer via both the dermal and inhalation routes of exposure in animals (Ref. 8).
      Most data on human health hazards resulting from diisocyanate exposures are from occupational populations rather than exposures to consumer products. As discussed in the Toluene Diisocyanate and Related Compounds Action Plan (Ref. 10), diisocyanates, including TDI and related compounds, are well-known dermal, eye, and inhalation irritants and sensitizers based on worker data. They have been documented in the workplace to cause asthma and respiratory problems, such as hypersensitivity pneumonitis, an inflammation of the lungs. In severe cases, there have been reported fatal reactions.
      Isocyanate exposure has been identified as the leading attributable cause of work-related asthma, and prevalence in the exposed workforce has been estimated at 1-20 percent (Refs. 11 and 12). Once a worker is sensitized to diisocyanates, subsequent exposures can trigger severe asthma attacks. Spray application and heated processes are associated with higher incidences of asthma than other application methods because they can generate airborne isocyanate vapors and mists, which lead to worker exposure via the respiratory and dermal routes. Most workers who develop diisocyanate asthma have experienced long periods of exposure (months or longer); however, the minimum exposure to isocyanates that can elicit sensitization responses or asthma is unknown. In addition, immune response and subsequent disease in humans can vary significantly between individuals (Ref. 6). Fatalities linked to diisocyanate exposures in sensitized persons have been reported (Refs. 13 and 14).
      The International Agency for Research on Cancer (IARC) classified toluene diisocyanates as "possibly carcinogenic to humans" (Carcinogenicity Group 2B), based on inadequate evidence for the carcinogenicity of TDI in humans and sufficient evidence for the carcinogenicity of TDI in experimental animals (Ref. 15). TDI has also been classified by the European Commission (EC) as Category 3 for carcinogenicity ("causes concerns for humans owing to possible carcinogenic effects") (Ref. 16) and by the United States National Toxicology Program (NTP) as "reasonably anticipated to be a human carcinogen" (Ref. 17). National Institutes for Occupational Safety and Health (NIOSH) considers TDI to be an occupational carcinogen and recommends exposure reduction to the lowest feasible levels (Ref 18).
There are very few reports available regarding non-occupational health effects from exposures to TDI products. However, there are case reports suggesting that paraoccupational (brought outside of the workplace) asthma may have resulted from incidental exposure to TDI, one of which involved incidental exposure to varnishing products (Ref. 19). A specific, potential concern for consumer products is exposures to children.  Children exposed to the same levels of TDI vapor as adults may receive a larger dose because they have greater lung surface area to body weight ratios and increased respiratory minute volumes to weight ratios. TDI vapor is heavier than air and may layer close to the floor; therefore, children who crawl, roll, or sit on surfaces treated with chemicals (i.e. carpets and floors) and play with objects such as toys where residues may settle could potentially receive higher doses of inhaled toxicants than adults present in the same room (Ref. 20).
   D.    What Are the Potential Route and Sources of Exposure to TDI and Related
Compounds?
      There is available information on worker exposures to industrial products containing TDI, such as coatings, adhesives, and sealants. Exposures resulting from the use of these industrial products may indicate potential but lower level exposures that may result for users conducting similar activities with consumer products containing residual TDI. There is a potential for worker exposure to TDI in all industrial and commercial settings where TDI is present (Ref. 7). Because of the high volatility of TDI, exposure can occur in all phases of its use, even in the final product (Ref.17), and it is unknown to what extent factors such as application techniques, product composition, and environmental conditions influence the availability of TDI in products. One activity where overexposures have been documented is floor finishing in both personal and area samples in one NIOSH evaluation (Ref. 21). Exposure data for professional workers may provide an indication of possible exposures if consumer products and articles were to contain residual TDI.
      As previously discussed, TDI is used in coatings, adhesives, sealants, and other polyurethane products. TDI is used in the manufacturing process of the polymer and as a result, a small percentage of TDI may be present in consumer products, including articles. Further, researchers looking at workplace exposures to diisocyanates have noted an increase in the number of isocyanate-containing products used by consumers (Ref. 6). In addition, consumer use of adhesives and sealants is a potential growth sector as seen in the increasing numbers of "Do It Yourself" (DIY), energy-conscious homeowners doing more of their own home renovation and repair work, as well as from craftsmen and consumers generally continuing to use adhesives (Ref. 22). Most consumers would be unaware of the potential hazards of consumer products, including articles, containing TDI or other diisocyanates. Consequently, insufficient and inadequate hazard communication may lead to incorrect use and increased consumer and bystander exposures, particularly for sensitive groups, such as children. For example, exposures to bystanders and building occupants (including children) to TDI in industrial products have been reported in the literature, including emissions of TDI from concrete patio sealants (Refs. 23 and 24) and detection of TDI in building air samples following use of urethanes containing TDI to coat wood floors (Ref. 25). It is possible that lower level exposures could occur when conducting comparable activities using similar types of consumer products containing residual TDI. Even if consumers are aware of such potential hazards, they may not take appropriate precautions or research the appropriate resources in which these precautions are addressed. Of particular concern is the fact that children may have a greater potential for exposure if they use or are bystanders to the use of consumer products containing even residual amounts of TDI, because they may not have fully developed judgment for following labeling instructions and safety precautions and may not cease activity even when they are experiencing symptoms of exposure.
III. Rationale and Objectives
 A. Rationale
      Diisocyanates are potent dermal and lung sensitizers and an attributable cause of work-related asthma worldwide (Ref. 26). In the past, consumer exposures have not been a focus of concern with respect to diisocyanates, because it had been assumed that consumers were generally exposed to products containing only completely cured polyurethanes, which have been generally considered to have low toxicity (Ref. 2). However, an increase in consumer use of polyurethane products that may further react and undergo "curing" could occur if consumer products, such as coatings, elastomers, adhesives, and sealants contained TDI in amounts greater than residual amounts. In such instances, TDI and related compounds that are not completely reacted upon their application can provide potential exposures both to the consumer as the direct user or to bystanders when products are used by others (Refs. 2 and 3). In sensitized individuals, exposure to even small amounts of diisocyanates may cause allergic respiratory reactions like asthma and severe breathing difficulties (Ref. 6). EPA believes that the use of any of these chemical substances in consumer products above current levels could significantly increase human exposure, and that such increase should not occur without an opportunity for EPA review and control as appropriate. As discussed in Unit II, regarding the chemicals listed in Table 2 of Unit II.A., based on Safety Data Sheets (SDS) information that coating-, adhesive-, elastomer-, binder-, or sealant-consumer products may contain residual TDI of no more than 0.1 percent by weight, EPA believes that these consumer products do not contain residual TDI of more than 0.1 percent by weight. EPA believes that other consumer products do not contain TDI or related compounds at any level.
      Consistent with EPA's past practice for issuing SNURs under TSCA section 5(a)(2), EPA's decision to propose a SNUR for a particular chemical use need not be based on an extensive evaluation of the hazard, exposure, or potential risk associated with that use. Rather, the Agency action is based on EPA's determination that if the use begins or resumes, it may present a risk that EPA should evaluate under TSCA before the manufacturing or processing for that use begins. Since the new use does not currently exist, deferring a detailed consideration of potential risks or hazards related to that use is an effective use of resources. If a person decides to begin manufacturing or processing the chemical for the use, the notice to EPA allows EPA to evaluate the use according to the specific parameters and circumstances surrounding that intended use.
 B. Objectives
 	Based on the considerations in Unit III.A., EPA wants to achieve the following objectives with regard to the significant new use(s) that are designated in this proposed rule:
 	1.  EPA would receive notice of any person's intent to manufacture or process TDI or its related compounds (see Tables 1 and  2 of Unit II.A.) for the described significant new use before that activity begins.
 	2.  EPA would have an opportunity to review and evaluate data submitted in a
 SNUN before the notice submitter begins manufacturing or processing TDI or its related compounds (see Tables 1 and 2 of Unit II.A.) for the described significant new use.
 	3.  EPA would be able to regulate prospective manufacturers or processors of TDI or its related compounds (see Table 1 of Unit II.A. and Table 2 of  Unit II.A.) before the described significant new use of the chemical substance occurs, provided that regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6 or 7.
 IV. Significant New Use Determination
 	Section 5(a)(2) of TSCA states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors including:
 	1.  The projected volume of manufacturing and processing of a chemical substance.
 	2.  The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.
       3.  The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.
 	4.  The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.
 		In addition to these factors enumerated in TSCA section 5(a)(2), the statute authorizes EPA to consider any other relevant factors.
 	To determine what would constitute a significant new use of TDI or its related compounds subject to this proposed rule, as discussed in this unit, EPA considered relevant information about the toxicity of these substances, likely human exposures and environmental releases associated with possible uses, and the four factors listed in section 5(a)(2) of TSCA. EPA has preliminarily determined as the significant new uses: any use in a consumer product for any chemical listed in Table 1 of Unit II.A.; and any use in a consumer product for any chemical listed in Table 2 of Unit II.A. (except for use in coatings, elastomers, adhesives, binders, and sealants that results in less than or equal to 0.1 percent by weight of TDI in a consumer product).
      The article exemption at 40 CFR 721.45(f) is based on an assumption that people and the environment will generally not be exposed to chemical substances in articles (see 49 FR 35014; September 5, 1984) (Ref. 1). However, TDI and related compounds are volatile and as such could migrate out of articles that contain them.  For instance, studies of TDI in polyurethane products reported that after the reaction between an isocyanate and an alcohol to form polyurethane products, residual levels of isocyanates were detected on the surface of the products, which if used could lead to exposure (Refs. 2 and 3).  Because TDI and related compounds are known to be volatile chemical substances, have been reported to migrate from products, are sensitizers, and would be expected to present a higher potential for exposure if the TDI in the article were a consumer product, EPA would like the opportunity to evaluate such potential uses in consumer products for any associated risks or hazards that might exist before those uses would begin.
      EPA believes any new use of TDI and related compounds as part of articles would increase the duration and magnitude of human exposure to the substance. Based on these considerations, EPA has preliminarily determined that importing or processing substances in Table 1 of Unit II.A. and Table 2 of Unit II.A. as part of articles warrants making inapplicable the article exemption at 40 CFR 721.45(f) for the significant new uses identified in the tables.
 V.  Applicability of General Provisions
 	General provisions for SNURs appear under 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the final rule. However, for this action, EPA is proposing that 40 CFR 721.45(f) (which generally exempts persons importing or processing a substance as part of an article) will not apply and a person who imports or processes a chemical substance as part of an article would not be exempt from submitting a SNUN.
 	Provisions relating to user fees appear at 40 CFR part 700. According to
  40 CFR 721.1(c), persons subject to SNURs must comply with the same notice requirements and EPA regulatory procedures as submitters of Premanufacture Notices (PMNs) under TSCA section 5(a)(1)(A). In particular, these requirements include the information submissions requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6 or 7 to control the activities on which it has received the SNUN. If EPA does not take action, EPA is required under TSCA section 5(g) to explain in the Federal Register its reasons for not taking action.
	Persons who export or intend to export a chemical substance identified in a proposed or final SNUR are subject to the export notification provisions of TSCA section 12(b). The regulations that interpret TSCA section 12(b) appear at 40 CFR part 707, subpart D. In accordance with 40 CFR 707.60(b) this proposed SNUR does not trigger export notification for articles. Persons who import a chemical substance identified in a final SNUR are subject to the TSCA section 13 import certification requirements, codified at 19 CFR 12.118 through 12.127; see also 19 CFR 127.28. Those persons must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA, including any SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. The TSCA section 13 import certification requirement applies to articles containing a chemical substance or mixture if so required by the Administrator by a specific rule under TSCA. At this time EPA is not proposing to require import certification for these chemical substances as part of articles.
VI. Applicability of Rule to Uses Occurring Before Effective Date of the Final Rule
      As discussed in the Federal Register of April 24, 1990 (55 FR 17376; FRL-3658-5) (Ref. 27), EPA has decided that the intent of section 5(a)(1)(B) of TSCA is best served by designating a use as a significant new use as of the date of publication of the proposed rule rather than as of the effective date of the final rule. If uses begun after publication of the proposed rule were considered ongoing rather than new, it would be difficult for EPA to establish SNUR notice requirements, because a person could defeat the SNUR by initiating the proposed significant new use before the rule became final, and then argue that the use was ongoing as of the effective date of the final rule. Thus, persons who begin commercial manufacture or processing of the chemical substance(s) that would be regulated through this proposed rule, if finalized, would have to cease any such activity before the effective date of the rule if and when finalized. To resume their activities, these persons would have to comply with all applicable SNUR notice requirements and wait until the notice review period, including all extensions, expires.  Uses arising after the publication of the proposed rule are distinguished from uses that exist at publication of the proposed rule. The former would be new uses, the latter ongoing uses, except that uses that are ongoing as of the publication of the proposed rule would not be considered ongoing uses if they have ceased by the date of issuance of a final rule. To the extent that additional ongoing uses are found in the course of rulemaking, EPA would exclude those specific chemical substances for those specific uses from the final SNUR. EPA has promulgated provisions to allow persons to comply with the final SNUR before the effective date. If a person were to meet the conditions of advance compliance under 40 CFR 721.45(h), that person would be considered to have met the requirements of the final SNUR for those activities.
 VII. Test Data and Other Information
 	EPA recognizes that TSCA section 5 does not usually require developing any particular test data before submission of a SNUN.  There are two exceptions:
 	 1.  Development of test data is required where the chemical substance subject to the SNUR is also subject to a test rule under TSCA section 4 (see TSCA section 5(b)(1)); and
 	2.  Development of test data may be necessary where the chemical substance has been listed under TSCA section 5(b)(4) (see TSCA section 5(b)(2)).
  In the absence of a section 4 test rule or a section 5(b)(4) listing covering the chemical substance, persons are required to submit only test data in their possession or control and to describe any other data known to or reasonably ascertainable by them (15 U.S.C. 2604(d); 40 CFR 721.25, and 40 CFR 720.50).  However, as a general matter, EPA recommends that SNUN submitters include data that would permit a reasoned evaluation of risks posed by the chemical substance during its manufacture, processing, use, distribution in commerce, or disposal.  EPA encourages persons to consult with the agency before submitting a SNUN.  As part of this optional pre-notice consultation, EPA would discuss specific data it believes may be useful in evaluating a significant new use.  SNUNs submitted for significant new uses without any test data may increase the likelihood that EPA will take action under TSCA section 5(e) to prohibit or limit activities associated with this chemical.
 	SNUN submitters should be aware that EPA will be better able to evaluate SNUNs that provide detailed information on:
 	::   Human exposure and environmental releases that may result from the significant new uses of the chemical substance,
 	::   Potential benefits of the chemical substance, and
 	::   Information on risks posed by the chemical substances compared to risks posed by potential substitutes.
 VIII. SNUN Submissions
	EPA recommends that submitters consult with the Agency prior to submitting a SNUN to discuss what data may be useful in evaluating a significant new use. Discussions with the Agency prior to submission can afford ample time to conduct any tests that might be helpful in evaluating risks posed by the substance. According to  40 CFR 721.1(c), persons submitting a SNUN must comply with the same notice requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in  40 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in  40 CFR 721.25 and 40 CFR 720.40. E-PMN software is available electronically at http://www.epa.gov/opptintr/newchems.
IX. Economic Analysis
 A.  SNUNs
 	EPA has evaluated the potential costs of establishing SNUR reporting requirements for potential manufacturers and processors of the chemical substances included in this proposed rule, including as part of articles (Ref. 28). In the event that a SNUN is submitted, costs are estimated at approximately $8,589 per SNUN submission for large business submitters and $6,189 for small business submitters. These estimates include the cost to prepare and submit the SNUN, and the payment of a user fee. Businesses that submit a SNUN would be subject to either a $2,500 user fee required by 40 CFR 700.45(b)(2)(iii), or, if they are a small business with annual sales of less than $40 million when combined with those of the parent company (if any), a reduced user fee of $100 (40 CFR 700.45(b)(1)). EPA's complete economic analysis is available in the public docket for this proposed rule (Ref. 28).
 B.  Export Notification
  	Under section 12(b) of TSCA and the implementing regulations at 40 CFR part 707, subpart D, exporters must notify EPA if they export or intend to export a chemical substance or mixture for which, among other things, a rule has been proposed or promulgated under TSCA section 5.  For persons exporting a substance that is the subject of a SNUR, a one-time notice must be provided for the first export or intended export to a particular country. The total costs of export notification will vary by chemical, depending on the number of required notifications (i.e., the number of countries to which the chemical is exported).  While EPA is unable to make any estimate of the likely number of export notifications for the chemical covered in this proposed SNUR, as stated in the accompanying EA of this proposed SNUR, the estimated cost of the export notification requirement on a per unit basis is $84.22
C. Import or Processing Chemical Substances as Part of an Article

 	In proposing to make inapplicable the exemption relating to persons that import or process certain chemical substances as part of an article, this action may affect firms that plan to import or process types of articles that may contain the subject chemical substance. Some firms have an understanding of the contents of the articles they import or process.  However, EPA acknowledges that importers and processors of articles may have varying levels of knowledge about the chemical content of the articles that they import or process. These parties may need to become familiar with the requirements of the rule. And, while not required by the SNUR, these parties may take additional steps to determine whether the subject chemical substances are part of the articles that they are considering to import or process. This determination may involve activities such as gathering information from suppliers along the supply chain, and/or testing samples of the article itself. Costs vary across the activities chosen and the extent of familiarity a firm has regarding the articles it imports or processes. Cost ranges are presented in the Understanding the Costs Associated with Eliminating Exemptions for Articles in SNURs (Ref.29). Based on available information, EPA believes that article importers that choose to investigate their products would incur costs at the lower end of the ranges presented in the Economic Analysis. For those companies choosing to undertake actions to assess the composition of the articles they import or process, EPA expects that importers would take actions that are commensurate with the company's perceived likelihood that a chemical substance might be a part of an article, and the resources it has available.  Example activities and their costs are provided in the accompanying Economic Analysis of this Rule (Ref. 28).
 X. Alternatives
 	Before proposing this SNUR, EPA considered the following alternative regulatory action:
 A. Promulgate a TSCA Section 8(a) Reporting Rule
 	Under a TSCA section 8(a) rule, EPA could, among other things, generally require persons to report information to the agency when they intend to manufacture or process a listed chemical for a specific use or any use.  However, for TDI, the use of TSCA section 8(a) rather than SNUR authority would have several limitations.  First, if EPA were to require reporting under TSCA section 8(a) instead of TSCA section 5(a), EPA would not have the opportunity to review human and environmental hazards and exposures associated with the proposed significant new use and, if necessary, take immediate follow-up regulatory action under TSCA sections 5(e) or 5(f) to prohibit or limit the activity before it begins.  In addition, EPA may not receive important information from small businesses, because such firms generally are exempt from TSCA section 8(a) reporting requirements (see TSCA sections 8(a)(1)(A) and 8(a)(1)(B)). In view of the level of health concerns about TDI if used for the proposed significant new use, EPA believes that a TSCA section 8(a) rule for this substance would not meet EPA's regulatory objectives.
 B.  Allow the Exemption for Persons Who Import or Process TDI and Related Compounds as Part of Articles That Would Be Subject to the Proposed SNUR
 	Under the SNUR exemption provision at  40 CFR 721.45(f), a person who imports or processes a chemical substance covered by a SNUR identified in 40 CFR part 721, subpart E, as part of an article is not generally subject to the notification requirements of  40 CFR 721.25 for that chemical substance. However, EPA is concerned that exempting TDI and related compounds as part of articles would render the SNUR less effective because of the possibility that articles could be imported or processed for uses subject to this proposed SNUR without the submission of a SNUN. This proposed rule would not include the exemption at  40 CFR 721.45(f).
 XI. Request for Comment
A. Do you have comments or information about ongoing uses?
	EPA welcomes comment on all aspects of this proposed rule. EPA based its understanding of the use profile of these chemicals on the published literature, the 2012 CDR submissions, market research, discussions with manufacturers, and product SDSs. To confirm EPA's understanding, the Agency is requesting public comment on the EPA's understanding that coating, adhesive, elastomer, binder, or sealant consumer products do not contain residual TDI of more than 0.1 percent by weight, as noted in Table 2 of Unit II.A. EPA believes that other consumer products do not contain TDI or related compounds at any level.  In providing comments on the concentration of TDI and related compounds in the consumer product, it would be helpful if you provide sufficient information for EPA to substantiate any assertions of use and concentrations.
B. What Should I Consider as I Prepare my Comments for EPA?
		1. Submitting CBI.  It is EPA's policy to include all comments received in the public docket without change or further notice to the commenter and to make the comments available on-line at www.regulations.gov, including any personal information provided, unless a comment includes information claimed to be CBI or other information whose disclosure is restricted by statute. Do not submit this information to EPA through regulations.gov or e-mail.  Clearly mark the part or all of the information that you claim to be CBI.  For CBI information in a disk or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM that you mail to EPA as CBI and then identify electronically within the disk or CD ROM the specific information that is claimed as CBI.  In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket.  Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2, subpart B.
		2. Tips for preparing your comments.  When submitting comments, remember to:
		i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date, and page number).
   	ii. Follow directions.  The agency may ask you to respond to specific questions or organize comments by referencing a CFR part or section number.
  	iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
     	iv. Describe any assumptions and provide any technical information and/or data that you used.
     	v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
     	vi. Provide specific examples to illustrate your concerns and suggest alternatives.
     	vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
      	viii. Make sure to submit your comments by the comment period deadline identified.
 XII. References
 	The following is a listing of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA, including documents that are referenced within the documents that are in the docket, even if the referenced document is not physically located in the docket.  For assistance in locating these other documents, please consult technical person listed under FOR FURTHER INFORMATION CONTACT.
      1. U.S. EPA. Significant New Uses of Chemical Substances; Certain Chemicals. 49 FR 35014, September 5, 1984 (FRL-2541-8). Krone, C., and Klinger, T. (2005). Isocyanates, polyurethane and childhood asthma. Pediatric Allergy and Immunology 16, 378-379.
      2. Krone, C., and Klinger, T. (2005). Isocyanates, polyurethane and childhood asthma. Pediatric Allergy and Immunology 16, 378-379.
	3. Bello, D., Herrick, C. A., Smith, T. J., Woskie, S. R., Streicher, R. P., Cullen,
M. R., Liu, Y., and Redlich, C. A. (2007). Skin Exposure to Isocyanates: Reasons for
Concern. Environmental Health Perspectives 115.
      4. BASF Corporation. (2011). Project Summary Report Requested Industrial Hygiene personal and Area Monitoring for Identified Airborne Chemical Hazards of MDI and/or TDI Associated with Isocyanate-Containing Product Use Scenarios for Identified Construction Sealants and/or Basecoat Products (Sanitized Version). JKInc. Report #: 111-11, 1- 6.
      5. Vangronsveld, E, Berckmans, S., and Spence, M. (2013). Comparison of Solvent/Derivatization Agent Systems for Determination of Extractable Toluene Diisocyanate from Flexible Polyurethane Foam. Annals of Occupational Hygiene 57(5), 640-649.
	6. Redlich, C. A., Bello, D., and Wisnewski, A. (2006). Isocyanate exposures and health effects. In Environmental and Occupational Medicine (W. Rom, and S.
Markowitz, Eds.), pp. 502-516. Lippincott Williams & Wilkins Philadelphia, PA.
      7. DOW (2009). Product Safety Assessment DOW Modified Toluene
Diisocyanate (TDI) Products. July 16 2010.
http://www.dow.com/PublishedLiterature/dh_034d/0901b8038034d515.pdf?filepath=pructsay/pdfs/noreg/233-00617.pdf&fromPage=GetDoc.
      8. Collins, M.A. (2002). Toxicology of Toluene Diisocyanate. Applied
Occupational and Environmental Hygiene 17, 846-855.
	9. Gledhill, A. Wake, A., Hext, P., Leiobold, E., and Shiotsuka, R. (2005).
Absorption, distribution, metabolism and excretion of an inhalation does of 14C 4,4'
methylenediphenyl diisocyanate in the male rat. Xenobiotica 35, 273-292.
      10.  EPA. 2011. Toluene Diisocyanate (TDI) and Related Compounds Action Plan. Available online at: http://www.epa.gov/oppt/existingchemicals/pubs/actionplans/tdi.pdf.
	11. Ott, M.G., Diller, W.F., and Jolly, A.T. (2003). Respiratory effects of toluene diisocyanates in the workplace; a discussion of exposure-response relationships. Critical Review Toxicology 33, 1-59.
      12. Bello, D., Woskie, S. R., Streicher, R. P., Liu, Y., Stowe, M. H., Eisen, E. A. Ellenbecker, M. J., Sparer, J., Youngs, F., Cullen, M. R., and Redlich, C. A. (2004).
Polyisocyanates in occupational environments: a critical review of exposure limits and
metrics. American Journal Industrial Medicine 46, 480-491.
      13. NIOSH (1996). National Institute for Occupational Safety and Health.
Preventing asthma and death from diisocyanate exposure: NIOSH Alert. (DHHS, Ed.).
      14. American Chemistry Council (ACC) (2005). TSCA Section 8(e) Notice of
Substantial Risk 8EHQ-0905-16225 Fatalities linked to diisocyanates. EPA.
      15. IARC. (1999).Toluene Diisocyanates. WHO. p. 865-879.
	16. Environment Canada. (2008). Screening Assessment for the Challenge:
Toluene Diisocyanate. http://www.ec.gc.ca/ese-ees/default.asp?lang=En&n=69A64ACA.
	17. NTP (2011). National Toxicology Program. Report on Carcinogens, Twelfth Edition; U.S. Department of Health and Human Services, Public Health Service. Substance Profile, Toluene Diisocyanates. http://ntp.niesh.nih.gov?objectid=03C9AF75-E1BF-FF40-DBA9EC0928DF8B15.
	18. NIOSH (2005). National Institute of Occupational Safety and Health. NIOSH Pocket Guide to Chemical Hazards July 16, 2010. http://www.cdc.gov/NIOSH/npg/npgdcas.html.
      19. De Zotti (2000). De Zotti, R., Muran, A., and Zambon, F. (2000). Two cases of paraoccupational asthma due to toluene diisocyanate (TDI). Occupational and Environmental Medicine 57, 837-839.
	20. Agency for Toxic Disease Registry (ATSDR) (2002). Case Studies in
Environmental Medicine: Pediatric Environmental Health. ATSDR Publication No.
ATSDR-HE-CD-2002-0002.
      21. NIOSH (2004). National Institute for Occupational Safety and Health. A
Summary of Health Hazard Evaluations: Issues Related to Occupational Exposure to
Isocyanates 1989-2002. (D. o. H. a. H. Services, Ed.), pp. 1-42, Cincinnati, OH
	22. Pianoforte, K. (2009). Adhesives and sealants market update, November 1,
2009. In Coatings World.
	23. Kelly, T. J., Myers, J. D., and Holdren, M. W. (1999). Testing of Household
Products and Materials for Emission of Toluene Diisocyanate. Indoor Air 9, 117-124.
	24. Jarand, C. W., Akapo, S. O., Swenson, L. J., and Kelman, B. J. (2002).
Diisocyanate emission from a paint product: a preliminary analysis. Applied
Occupational Environmental Hygiene 17, 491-494.
	25. NYC-DOHMH (2010). New York City Department of Health and Mental
Hygiene. Moisture Cure Urethanes (MCU). July 16, 2010. http://www.nyc.gov/html/doh/html/epi/mcufact.shtml.
      26. NIOSH (2006). National Institute for Occupational Safety and Health.
Preventing Asthma and Death from MDI Exposure During Spray-on Truck Bed Liner and Related Applications: NIOSH Alert. http://www.cdc.gov/niosh/docs/2006-149/default.html.
      27. U.S. EPA. Significant New Uses of Certain Chemical Substances.
55 FR 173776, April 24, 1990 (FRL-3658-5).
      28. EPA. Economic Analysis of the Significant New Use Rule for Toluene
Diisocyanate (TDI) and Related Compounds. April 2, 2014.
	29. EPA, Understanding the Costs Associated with Eliminating
Exemptions for Articles in SNURs. May 1, 2013.
XIII. Statutory and Executive Order Reviews
A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review
	This proposed SNUR has been designated by the Office of Management and Budget (OMB) as a ``significant regulatory action'' under section 3(f) of Executive Order (58 FR 51735, October 4, 1993). Accordingly, EPA submitted this action to OMB for review under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011), and any changes made in response to OMB recommendations are documented in the docket.
B. Paperwork Reduction Act (PRA)
      This action does not impose any new information collection burden under the PRA, 44 U.S.C. 3501 et seq. Burden is defined in 5 CFR 1320.3(b).  The information collection activities associated with existing chemical SNURs are already approved by OMB under OMB control number 2070-0038 (EPA ICR No. 1188); and the information collection activities associated with export notifications are already approved by OMB under OMB control number 2070-0030 (EPA ICR No. 0795).  If an entity were to submit a SNUN to the Agency, the annual burden is estimated to be less than 100 hours per response, and the estimated burden for an export notifications is less than 1.5 hours per notification. In both cases, burden is estimated to be reduced for submitters who have already registered to use the electronic submission system. Additional burden, estimated to be less than 10 hours, could be incurred where additional record keeping requirements are specified under 40 CFR 721.125(a), (b), and (c).
      An agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under the PRA, unless it has been approved by OMB and displays a currently valid OMB control number.  The OMB control numbers for EPA's regulations in Title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR, part 9, and included on the related collection instrument, or form, if applicable. EPA is amending the table in 40 CFR part 9 to list this SNUR. This listing of the OMB control numbers and their subsequent codification in the CFR satisfies the display requirements of the PRA and OMB's implementing regulations at 5 CFR part 1320. Since the existing OMB approval was previously subject to public notice and comment before OMB approval, and given the technical nature of the table, EPA finds that further notice and comment to amend the table is unnecessary. As a result, EPA finds that there is "good cause" under section 553(b)(3)(B) of the Administrative Procedure Act (5 U.S.C. 553(b)(3)(B)) to amend this table without further notice and comment.
C. Regulatory Flexibility Act (RFA)
      Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the agency hereby certifies that promulgation of this SNUR would not have a significant adverse economic impact on a substantial number of small entities. The rationale supporting this conclusion is as follows.
      A SNUR applies to any person (including small or large entities) who intends to engage in any activity described in the rule as a "significant new use." By definition of the word "new" and based on all information currently available to EPA, it appears that no small or large entities presently engage in such activities. Since this proposed SNUR would require a person who intends to engage in such activity in the future to first notify EPA by submitting a SNUN, no economic impact will occur unless someone files a SNUN to pursue a significant new use in the future or forgoes profits by avoiding or delaying the significant new use. Although some small entities may decide to conduct such activities in the future, EPA cannot presently determine how many, if any, there may be. However, EPA's experience to date is that, in response to the promulgation of SNURs covering over chemical substances, the agency receives on average only a handful of notices per year. During the six year period from 2005-2011, only three submitters self-identified as small in their SNUN submission (Ref. 26). EPA believes the cost of submitting a SNUN is relatively small compared to the cost of developing and marketing a chemical new to a firm and that the requirement to submit a SNUN generally does not have a significant economic impact.
      EPA believes that there will be minimal impact to processors and importers of the chemical substance subject to the final SNUR as part of an article. The SNUR does not require processors and importers of articles that contain the chemicals subject to the proposed SNUR to conduct specific activities to ascertain if they are importing or processing an article that uses a chemical subject to the rule. EPA expects importers would take actions that are commensurate with their perceived likelihood of a chemical substance subject to the SNUR being part of an article, and the resources it has available. EPA has no reason to believe that a firm would voluntarily incur substantial costs to comply with the SNUR, but rather EPA believes each firm will choose the most efficient route to identify whether it is importing the subject chemical substances in articles
      Therefore, EPA believes that the potential economic impact of complying with this proposed SNUR is not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published as a final rule on August 8, 1997 (62 FR 42690)(FRL-5735-4), the Agency presented its general determination that proposed and final SNURs are not expected to have a significant economic impact on a substantial number of small entities, which was provided to the Chief Counsel for Advocacy of the Small Business Administration.
D. Unfunded Mandates Reform Act (UMRA)
	Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reason to believe that any State, local, or Tribal government would be impacted by this rulemaking. As such, the requirements of sections 202, 203, 204, or 205 of UMRA, 2 U.S.C. 1531-1538, do not apply to this action.
E. Executive Order 13132: Federalism
	This action will not have a substantial direct effect on 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, August 10, 1999).
F. Executive Order 13175: Consultation and Coordination with Indian Tribal Governments
	This proposed rule does not have Tribal implications because it is not expected to have any effect (i.e., there will be no increase or decrease in authority or jurisdiction) 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. Thus, Executive Order 13175 (65 FR 67249, November 9, 2000), does not apply to this action.
G. Executive Order 13045: Protection of Children from Environmental Health Risks and Safety Risks
	This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because this action is not intended to address environmental health or safety risks for children.
H. Executive Order 13211: Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use
	This proposed rule is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use.
I. National Technology Transfer and Advancement Act (NTTAA)
	Since this action does not involve any technical standards, section 12(d) of NTTAA, 15 U.S.C.272 note, does not apply to this section.
J. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations
	This proposed rule does not invoke special consideration of environmental justice related issues as delineated by Executive Order 12898 (59 FR 7629, February 16, 1994), because EPA has determined that this action will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations. This action does not affect the level of protection provided to human health or the environment.

List of Subjects in 40 CFR Part 721
 	Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements.

Dated: _______________________

____________________________________________

Director, Office of Pollution Prevention and Toxics.
      Therefore, it is proposed that 40 CFR chapter I be amended as follows:
 PART 721--[AMENDED]
	1. The authority citation for part 721 continues to read as follows:
 	Authority:  15 U.S.C. 2604, 2607, and 2625(c).
 	2. Add §721.10789 to subpart E to read as follows:
§721.10789 Toluene diisocyanates and related compounds.

 	(a) Chemical substances and significant new uses subject to reporting.  (1) The chemical substances listed in Table 1 and Table 2 of this paragraph are subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.
Table 1. -- Toluene Diisocyanates ad Related Compounds Subject to Reporting for Any Use in a Consumer Product
Chemical Name
Chemical Abstracts Index Name
Chemical Abstracts Service Registry (CASRN)
Toluene diisocyanate trimer
Benzene, 1,3-diisocyanatomethyl-, trimer
9019-85-6
Poly(toluene diisocyanate)
Benzene, 1,3-diisocyanatomethyl-, homopolymer
9017-01-0
Toluene diisocyanate dimer
1,3-Diazetidine-2,4-dione, 1,3 - bis(3-isocyanatomethylphenyl)-
26747-90-0

Toluene diisocyanate "cyclic" trimer
1,3,5-Triazine-2,4,6(1H,3H,5H) - trione, 1,3,5-tris(3 - isocyanatomethylphenyl)-
26603-40-7

Table 2. -- Toluene Diisocyanates ad Related Compounds Subject to Reporting for Any Use in A Consumer Product (Except for use in Coatings, Adhesives, Elastomers, Binders, and Sealants at Less than or Equal to 0.1 Percent in a Consumer Product)

Chemical Name
Chemical Abstracts Index Name
Chemical Abstracts Service Registry Number (CASRN)
2,6-Toluene diisocyanate
Benzene, 1,3-diisocyanato-2-methyl-
91-08-7
2,4-Toluene diisocyanate
Benzene, 2,4-diisocyanato-1-methyl-
584-84-9
Toluene diisocyanate unspecified isomers
Benzene, 1,3-diisocyanatomethyl-
26471-62-5

      (2) The significant new uses are:
      (i) For the chemical substances listed in Table 1 of paragraph (a)(1), any use of the chemical substance in consumer products.
      (ii) For the chemical substances listed in Table 2 of paragraph (a)(1), any use of the chemical substance in a consumer product (except for use in coatings, adhesives, elastomers, binders, and sealants, that results in less than or equal to 0.1 percent by weight of such chemical substance in the consumer product).
      (b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b):
      (1) Revocation of certain notification exemptions. The provisions of § 721.45(f) do not apply to this section. A person who imports or processes a chemical substance identified in paragraph (a)(1) of this section as part of an article for a significant new use described in paragraph (a)(2) of this section is not thereby exempt from submitting a significant new use notice.
      (2) [Reserved]