[Federal Register Volume 61, Number 210 (Tuesday, October 29, 1996)]
[Rules and Regulations]
[Pages 55872-55875]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-27588]


      

[[Page 55871]]


_______________________________________________________________________

Part III





Environmental Protection Agency





_______________________________________________________________________



40 CFR Parts 712 and 716



Preliminary Assessment Information and Health and Safety Data 
Reporting; Addition of Chemicals; Final Rule

  Federal Register / Vol. 61, No. 210 / Tuesday, October 29, 1996 /  
Rules and Regulations  

[[Page 55872]]



ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 712 and 716

[OPPTS-82049; FRL-5397-9]


Preliminary Assessment Information and Health and Safety Data 
Reporting; Addition of Chemicals

Agency: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The TSCA Interagency Testing Committee (ITC) in its 38th 
Report to EPA revised the Toxic Substances Control Act (TSCA) Section 
4(e) Priority Testing List by recommending for testing 18 chemical 
substances. The ITC recommendations must be given priority 
consideration by EPA in promulgating test rules. EPA is adding certain 
of these chemical substances to two model information-gathering rules: 
the TSCA Section 8(a) Preliminary Assessment Information Rule (PAIR) 
and the TSCA Section 8(d) Health and Safety Data Reporting Rule. These 
model rules will require manufacturers and importers of the substances 
identified herein to report certain production, use, and exposure-
related information, and manufacturers, importers, and processors of 
the listed substances to report unpublished health and safety data to 
EPA.

DATES: This rule will become effective on November 29, 1996.

FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director, TSCA 
Environmental Assistance Division (7408), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 401 M St., SW., 
Rm. E-543, Washington, DC 20460, Telephone: (202) 554-1404, TDD: (202) 
554-0551, e-mail: TSCA-H[email protected].

SUPPLEMENTARY INFORMATION: This rule adds 18 chemical substances to the 
PAIR and the section 8(d) Health and Safety Data Reporting Rule. 
Manufacturers, importers, and processors of these chemicals will be 
required to report unpublished health and safety data, and 
manufacturers and importers will be required to report end use, 
exposure, and production volume data to EPA.
    This rule also corrects the previous TSCA section 8(a) final rule 
published in the Federal Register of February 28, 1996 (61 FR 7421) 
(FRL-4996-9), by replacing the incorrect CAS number for (1,1,3,3-
tetramethylbutyl)phenol (mixed isomers) 2744-41-6 with the correct CAS 
number for that chemical, 62744-41-6.

I. Background

    Section 4(e) of TSCA established the ITC and authorized it to 
recommend to EPA chemical substances and mixtures (chemicals) to be 
given priority consideration in proposing test rules under section 4. 
For some of these chemicals, the ITC may designate that EPA must 
respond to its recommendations within 12 months. In this time, EPA must 
either initiate a rulemaking to test the chemical or publish in the 
Federal Register its reasons for not doing so.
    On May 31, 1996, EPA announced the receipt of the 38th Report of 
the ITC, and it was then published in the Federal Register of July 30, 
1996 (61 FR 39832) (FRL-5397-2). The 38th Report revises the 
Committee's Priority Testing List of chemicals by recommending for 
testing 18 chemical substances to the section 4(e) Priority Testing 
List.
    This rule adds 18 substances to the PAIR and the section 8(d) 
Health and Safety Data Reporting Rule. These two rules are model 
information gathering rules which assist the ITC in making testing 
recommendations and aid EPA in responding to the ITC recommendations.
    EPA issued the PAIR under section 8(a) of TSCA (15 U.S.C. 2607(a)), 
and it is codified at 40 CFR part 712. This model section 8(a) rule 
establishes standard reporting requirements for manufacturers and 
importers of the chemicals listed in the rule at 40 CFR 712.30. These 
manufacturers and importers are required to submit a one-time report on 
general volume, end use, and exposure-related information using the 
Preliminary Assessment Information Manufacturer's Report (EPA Form 
7710-35). EPA uses this model section 8(a) rule to gather current 
information on chemicals for the ITC quickly.
    EPA issued the model Health and Safety Data Reporting Rule under 
section 8(d) of TSCA (15 U.S.C. 2607(d)), and it is codified at 40 CFR 
part 716. The section 8(d) model rule requires past, current, and 
prospective manufacturers, importers, and processors of listed 
chemicals to submit to EPA copies and lists of unpublished health and 
safety studies on the listed chemicals that they manufacture, import, 
or process. These studies provide the ITC and EPA with useful 
information for chemical assessment and have provided significant 
support for EPA's decisionmaking under TSCA sections 4, 5, 6, 8, and 9.
    These model rules provide for the automatic addition of ITC 
Priority Testing List chemicals. Whenever EPA announces the receipt of 
an ITC report, EPA may, at the same time without further notice and 
comment, amend the two model information-gathering rules by adding the 
recommended (or designated) chemicals. The amendment adding these 
chemicals to the PAIR and the Health and Safety Data Reporting Rule 
becomes effective 30 days after publication in the Federal Register.

II. Chemicals To Be Added

    In its 38th Report to EPA, the ITC recommended adding a group of 18 
nonylphenol ethoxylates to the section 8(a) PAIR and the section 8(d) 
Health and Safety Data Reporting Rule. While 18 chemical substances are 
identified in the regulatory text, 23 CAS numbers are listed. Three 
chemical substances, nonylphenol polyethylene glycol ether, p-
nonylphenol polyethylene glycol ether and nonylphenoxypolyoxyethanol 
are characterized with multiple CAS numbers. Four chemical substances 
are not identified by CAS numbers.
    For a complete listing of the subtances being added to the section 
8(d) model rule and the PAIR, see the regulatory text of this document.

III. Reporting Requirements

A. Preliminary Assessment Information Rule

    All persons who manufactured or imported the chemical substances 
named in this rule during their latest complete corporate fiscal year 
must submit a Preliminary Assessment Information Manufacturer's Report 
(EPA Form No. 7710-35) for each manufacturing or importing site at 
which they manufactured or imported a named substance. A separate form 
must be completed for each substance and submitted to the Agency no 
later than January 27, 1997. Persons who have previously and 
voluntarily submitted a Manufacturer's Report to the ITC or EPA may be 
able to submit a copy of the original Report to EPA or to notify EPA by 
letter of their desire to have this voluntary submission accepted in 
lieu of a current data submission. See Sec. 712.30(a)(3).
    Details of the reporting requirements, the basis for exemptions, 
and a facsimile of the reporting form, are provided in 40 CFR part 712. 
Copies of the form are available from the TSCA Environmental Assistance 
Division at the address listed under FOR FURTHER INFORMATION CONTACT.

B. Health and Safety Data Reporting Rule

    Listed below are the general reporting requirements of the section 
8(d) model rule.

[[Page 55873]]

    1. Persons who, in the 10 years preceding the date a substance is 
listed, either have proposed to manufacture, import, or process, or 
have manufactured, imported, or processed, the listed substance must 
submit to EPA: A copy of each health and safety study which is in their 
possession at the time the substance is listed.
    2. Persons who, at the time the substance is listed, propose to 
manufacture, import, or process; or are manufacturing, importing, or 
processing the listed substance must submit to EPA:
    a. A copy of each health and safety study which is in their 
possession at the time the substance is listed.
    b. A list of health and safety studies known to them but not in 
their possession at the time the substance is listed.
    c. A list of health and safety studies that are ongoing at the time 
the substance is listed and are being conducted by or for them.
    d. A list of each health and safety study that is initiated after 
the date the substance is listed and is conducted by or for them.
    e. A copy of each health and safety study that was previously 
listed as ongoing or subsequently initiated and is now complete--
regardless of completion date.
    3. Persons who, after the time the substance is listed, propose to 
manufacture, import, or process the listed substance must submit to 
EPA:
    a. A copy of each health and safety study which is in their 
possession at the time they propose to manufacture, import, or process 
the listed substance.
    b. A list of health and safety studies known to them but not in 
their possession at the time they propose to manufacture, import, or 
process the listed substance.
    c. A list of health and safety studies that are ongoing at the time 
they propose to manufacture, import, or process the listed substance, 
and are being conducted by or for them.
    d. A list of each health and safety study that is initiated after 
the time they propose to manufacture, import, or process the listed 
substance, and is conducted by or for them.
    e. A copy of each health and safety study that was previously 
listed as ongoing or subsequently initiated and is now complete--
regardless of the completion date.
    The bulk of reporting is required at the time the substance is 
listed. Persons described in categories 1 and 2 do all or most of their 
health and safety data reporting at the start of the reporting period. 
The remaining reporting requirements, specifically categories 2(d), 
2(e), and 3, continue prospectively. Guidance for reporting unpublished 
health and safety data is provided at 40 CFR part 716.
    4. Special exemptions.--Explanations of reporting exemptions are 
found at 40 CFR 716.20. For this final rule all the chemicals listed 
have a special exemption referenced at Sec. 716.20(b)(4) which states 
that studies on mixtures containing the listed substances at levels 
below one percent of the mixture, except when a purpose of the study 
includes the investigation of the effects of the listed substance at 
the levels below one percent, are not subject to the reporting 
requirements.

C. Submission of PAIR Reports and Section 8(d) Studies

    PAIR reports and section 8(d) health and safety studies must be 
sent to:
    TSCA Document Processing Center (7407), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460, ATTN: (insert either PAIR or 8(d) Reporting).

D. Removal of Chemical Substances from the Rules

    Any person who believes that section 8(a) or 8(d) reporting 
required by this rule is unwarranted, should promptly submit to EPA in 
detail the reasons for that belief. EPA, in its discretion, may remove 
the substance from this rule for good cause (40 CFR 716.105). When 
withdrawing a substance from the rule, EPA will issue a rule amendment 
for publication in the Federal Register.

IV. Economic Analysis

A. Preliminary Assessment Information Rule

    The economic analysis for the addition of the 18 chemicals to the 
TSCA Section 4(e) Priority List will be based largely on the methods 
and data sources developed for the analyses of the original Section 
8(a) Preliminary Assessment Information Rule (PAIR). These analyses 
are:
    1. Economic Impact and Small Business Definition Analysis for TSCA 
Section 8(a) Preliminary Assessment Information Rule. Office of 
Regulatory Analysis, OTS, U.S. EPA. February 1980.
    2. Economic Analysis of the Final Section 8(a) Preliminary 
Assessment Information Rule. R.A. Horner, Regulatory Impacts Branch, 
OTS, U.S. EPA. November 12, 1981.
    The Chemical Update System (CUS) was searched to determine the 
manufacturers and importers of the 18 chemicals. However, only 5 of 
these 18 chemicals were located in CUS. Thus, this report shall 
estimate burden and costs based upon 5 chemical compounds. This search 
identified 6 firms manufacturing or importing the 5 chemicals at a 
total of 6 sites. Manufacturing and/or importing sites were identified 
for all the chemicals.
                    Reporting Costs (dollars)
(a) 6 reports estimated at $1,515 per report = $9,090
(b) 6 sites at $476.18 per site = $2,857.08
Total Cost = $11,947.08
Mean cost per site = $11,947.08/6 sites = $1,991.18
Mean cost per firm = $11,947.08/6 firms = $1,991.18
                    Reporting Burden (hours)
(a) Rule familiarization: 7 hours/site x 6 sites = 42
(b) Reporting: 22.61 hours/report x 6 reports = 135.66
Total burden hours = 177.66
Average burden per site = 177.66 hours/6 sites = 29.61
Average burden per firm = 177.66 hours/6 firms = 29.61
                    EPA Costs (dollars)
    It is estimated that the annual cost to the Federal Government will 
be 1.315 FTEs (or 2,735 hours annually). At an estimated $69,370 per 
FTE, the total of 1,315 FTEs will cost EPA $91,222.

B. Health and Safety Data Reporting Rule

    EPA estimates the total reporting costs for establishing section 
8(d) reporting requirements for the five chemicals will be $15,527. 
This cost estimate is high because the Agency is uncertain about the 
likely number of respondents to the rule. Although EPA has used the 
best available data to make its economic projections, much of the 
information is based upon the 1994 TSCA Inventory Update. Therefore, 
EPA tends to overestimate rather than underestimate reporting burden.
    The estimated reporting costs are broken down as follows:

                                                                        
------------------------------------------------------------------------
                                                                        
------------------------------------------------------------------------
Initial corporate review                                            $952
                                                                        
Site identification                                                1,427
                                                                        
File searches at site                                              3,217
                                                                        
Photocopying existing studies                                      1,256
                                                                        
Title listing                                                        145
                                                                        
Managerial review for CBI                                          7,296
                                                                        
Reporting on newly-initiated studies                                  62
                                                                        

[[Page 55874]]

                                                                        
Submissions after initial reporting period                         1,116
                                                                        
Additional costs                                                      56
Total                                                            $15,527
------------------------------------------------------------------------

                Reporting Burden (hours)
(a) Initial review: 2 hours/firm x 6 firms = 12 hrs
(b) Reporting: 39.33 hours/firm x 6 firms = 236 hrs
Total reporting burden hours = 248 hrs

V. Rulemaking Record

    The following documents constitute the record for this rule (docket 
control number OPPTS-82049). All of these documents are available to 
the public in the TSCA Nonconfidential Information Center (NCIC), 
formerly the TSCA Public Docket Office, from 12 noon to 4 p.m., Monday 
through Friday, excluding legal holidays. The TSCA NCIC is located at 
EPA Headquarters, Rm. NE-B607, 401 M St., SW., Washington, DC 20460.
    1. This final rule.
    2. The economic analysis for this rule.
    3. The Thirty-eighth Report of the ITC.

VI. Regulatory Assessment Requirements

A. Executive Orders 12866 and 12898

    The Office of Management (OMB) has exempted actions under TSCA 
section 8(a) and 8(d) from the requirements of Executive Order l2866 
(58 FR 51735, October 4, 1993). In addition, this action does not 
require prior consultation with State officials as specified by 
Executive Order 12875 (58 FR 58093, October 28, 1993) nor does it 
involve specified considerations of environmental justice related 
issues as required by Executive Order 12898 (59 FR 7629, February 16, 
1994).

B. Unfunded Mandates Reform Act and Executive Order 12875

    This action will not result in the annual expenditure of $100 
million or more, for State, local or tribal governments, in the 
aggregate or the private sector, and is not a Federal mandate, as 
defined by the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 
104-4), nor does it uniquely affect small government in any way. As 
such, the requirements of sections 202, 203, and 205 of Title II of the 
UMRA do not apply to this action.

C. Regulatory Flexibility Act

    EPA has determined that this action does not impose any adverse 
economic impacts on small entities. Pursuant to 605(b) of the 
Regulatory Flexibility Act (5 U.S.C. 601 et seq.), this action will not 
impose a significant economic impact on a substantial number of small 
entities. Information relating to this determination is included in the 
docket for rulemaking. Any comments regarding the economic impacts that 
this action imposes on small entities should be submitted to the Agency 
at the address listed under FOR FURTHER INFORMATION CONTACT.

D. Paperwork Reduction Act

    In accordance with the Paperwork Reduction Act (PRA), 44 U.S.C. 
3501 et seq., an agency may not conduct or sponsor, and a person is not 
required to respond to an information collection request unless it 
displays a currently valid control number assigned by OMB. The OMB 
control number for EPA's regulations are listed in 40 CFR part 9 and 48 
CFR chapter 15. The information collection requirements related to this 
action have already been approved by OMB, under OMB control number 
2070-0054 (EPA ICR No. 586) for PAIR reporting and OMB control number 
2070-0004 (EPA ICR No. 575) for TSCA section 8(d) reporting. This 
action does not impose any burdens requiring additional OMB approval. 
The public reporting burden for this collection of information is 
estimated to be 248 hours. Of that total, an estimated 12 hours are 
spent performing an initial review of the rule. The remaining 236 hours 
are associated with the actual reporting activities.

E. Submission to Congress and the General Accounting Office

    This action in not a ``major rule'' as defined by 5 U.S.C. 804(2). 
Pursuant to 5 U.S.C. 801(a)(1)(A), EPA submitted this action to the 
U.S. Senate, the U.S. House of Representatives, and the Comptroller 
General of the General Accounting Office prior to its publication in 
today's Federal Register.

List of Subjects in 40 CFR Parts 712 and 716

    Environmental protection, Chemicals, Hazardous substances, Health 
and safety data, Reporting and recordkeeping requirements.

    Dated: October 21, 1996.
Charles M. Auer,
Director, Chemical Control Division, Office of Pollution Prevention and 
Toxics.
    Therefore, 40 CFR Chapter I is amended as follows:

PART 712--[AMENDED]

    1. In part 712:

    a. The authority citation for part 712 continues to read as 
follows:

    Authority: 15 U.S.C. 2607(a).

    b. Section 712.30(e) is amended by revising the CAS number entry 
for ``2744-41-6'' under the category ``Alkylphenols and Alkylphenol 
Ethoxylates'' and alphabetically adding the new category ``Nonylphenol 
ethoxylates'' to read as follows:


Sec. 712.30   Chemical lists and reporting periods.

    *    *    *    *    *
    (e)  *  *  *

                                                                                                                
----------------------------------------------------------------------------------------------------------------
                  CAS No.                              Substance              Effective date     Reporting date 
----------------------------------------------------------------------------------------------------------------
                                                                                                                
                         *        *        *        *        *        *        *                                
Alkylphenols and Alkylphenol Ethoxylates                                                                        
                                                                                                                
                         *        *        *        *        *        *        *                                
  62744-41-6                                *  *  *                                   *  *  *            *  *  *
                                                                                                                
                         *        *        *        *        *        *        *                                
Nonylphenol ethoxylates                                                                                         
  07311-27-5..............................  Ethanol, 2-[2-[2-[2-(p-                  11/29/96            1/27/97
                                             nonylphenoxy)ethoxy]ethoxy]et                                      
                                             hoxy]-                                                             
  09016-45-9 and 20636-48-0...............  Nonylphenol polyethylene                 11/29/96            1/27/97
                                             glycol ether                                                       
  20427-84-3..............................  Ethanol, 2-[2-(p-                        11/29/96            1/27/97
                                             nonylphenoxy)ethoxy]-                                              

[[Page 55875]]

                                                                                                                
  26027-38-3 and 26064-02-8...............  p-Nonylphenol polyethylene               11/29/96            1/27/97
                                             glycol ether                                                       
  26571-11-9..............................  Nonylphenol                              11/29/96            1/27/97
                                             octa(oxyethylene)ethanol                                           
  27176-93-8 and 27177-01-1...............  Nonylphenoxydiglycol                     11/29/96            1/27/97
  27177-05-5..............................  Nonylphenol                              11/29/96            1/27/97
                                             hepta(oxyethylene)ethanol                                          
  27177-08-8..............................  Nonylphenolnona(oxyethylene)             11/29/96            1/27/97
                                             ethanol                                                            
  27986-36-3..............................  Nonylphenoxy ethanol                     11/29/96            1/27/97
  37205-87-1..............................  Poly(oxy-1,2-ethanediyl),                11/29/96            1/27/97
                                             alpha-(isononylphenyl)-omega-                                      
                                             hydroxy                                                            
                                                                                                                
                         *        *        *        *        *        *        *                                
----------------------------------------------------------------------------------------------------------------

PART 716--[AMENDED]

    2. In part 716:
    a. The authority citation for part 716 continues to read as 
follows:

    Authority: 15 U.S.C. 2607(d).

    b. Section 716.120(d) is amended by revising the table heading for 
the second column and alphabetically adding the new category 
``Nonylphenol ethoxylates'' to read as follows:


Sec. 716.120   Substances and listed mixtures to which this subpart 
applies.

    *  *  *  *  *
    (d)  *  *  *

                                                                                                                
----------------------------------------------------------------------------------------------------------------
            Category                   CAS number       Special exemptions    Effective date      Sunset date   
----------------------------------------------------------------------------------------------------------------
                                                                                                                
                         *        *        *        *        *        *        *                                
Nonylphenol ethoxylates                                                                                         
  alpha-(p-Nonylphenol)-omega-    NA                   Sec.  716.20(b)(4)            11/29/96           11/29/06
   hydroxypoly(oxyethylene).                            applies                                                 
  Decaethylene glycol,            65455-72-3           Sec.  716.20(b)(4)            11/29/96           11/29/06
   isononylphenyl ether.                                applies                                                 
  Ethanol, 2-[2-(p-               20427-84-3           Sec.  716.20(b)(4)            11/29/96           11/29/06
   nonylphenoxy)ethoxy]-.                               applies                                                 
  Ethanol, 2-[2-[2-[2-(p-         07311-27-5           Sec.  716.20(b)(4)            11/29/96           11/29/06
   nonylphenoxy)                                        applies                                                 
   ethoxy]ethoxy]ethoxy]-.                                                                                      
  Nonoxynol-2...................  NA                   Sec.  716.20(b)(4)            11/29/96           11/29/06
                                                        applies                                                 
  Nonoxynol-3...................  NA                   Sec.  716.20(b)(4)            11/29/96           11/29/06
                                                        applies                                                 
  Nonoxynol-7...................  NA                   Sec.  716.20(b)(4)            11/29/96           11/29/06
                                                        applies                                                 
  Nonylphenol                     27177-05-5           Sec.  716.20(b)(4)            11/29/96           11/29/06
   hepta(oxyethylene)ethanol.                           applies                                                 
  Nonylphenol                     26571-11-9           Sec.  716.20(b)(4)            11/29/96           11/29/06
   octa(oxyethylene)ethanol.                            applies                                                 
  Nonylphenol polyethylene        09016-45-9, 20636-   Sec.  716.20(b)(4)            11/29/96           11/29/06
   glycol ether.                   48-0, 26027-38-3,    applies                                                 
                                   26064-02-8, 27177-                                                           
                                   01-1, 37205-87-1,                                                            
                                   127087-87-0                                                                  
  Nonylphenol polyethylene        27177-08-8           Sec.  716.20(b)(4)            11/29/96           11/29/06
   glycol ether.                                        applies                                                 
  Nonylphenolnona(oxyethylene)    27986-36-3           Sec.  716.20(b)(4)            11/29/96           11/29/06
   ethanol.                                             applies                                                 
  Nonylphenoxy ethanol..........  27176-93-8           Sec.  716.20(b)(4)            11/29/96           11/29/06
                                                        applies                                                 
  Nonylphenoxydiglycol..........  68412-54-4           Sec.  716.20(b)(4)            11/29/96           11/29/06
                                                        applies                                                 
  Nonylphenoxypolyoxyethanol....  152143-22-1, 26027-  Sec.  716.20(b)(4)            11/29/96           11/29/06
                                   38-3                 applies                                                 
  p-Nonylphenol polyethylene      27986-36-3, 37205-   Sec.  716.20(b)(4)            11/29/96           11/29/06
   glycol ether.                   87-1, 98113-10-1     applies                                                 
  Poly(oxy-1,2-ethanediyl),       37205-87-1           Sec.  716.20(b)(4)            11/29/96           11/29/06
   alpha-(isononylphenyl)-omega-                        applies                                                 
   hydroxy.                                                                                                     
  Poly(oxy-1,2-ethanediyl),       51938-25-1           Sec.  716.20(b)(4)            11/29/96           11/29/06
   alpha-(2-nonylphenyl)-omega-                         applies                                                 
   hydroxy.                                                                                                     
                                                                                                                
                         *        *        *        *        *        *        *                                
----------------------------------------------------------------------------------------------------------------


[FR Doc. 96-27588 Filed 10-28-96; 8:45 am]
BILLING CODE 6560-50-F