Federal Register / Vol. 53, No. 221 / Wednesday, November 16, 1988 /'Rules and Regulations 46279 ENVIONMETAL ROTETIO
ENVIRONMENTAL PROTECTION AGENCY

40 CFRParts712 and 716
[OPTS44029; FRL-3476-3] PreliminaryAssessment Information and Health and Safety Data Reporting; Addition ofChemicals
AGENCY. Environmental Protection Agency (EPA) ACTION: Final rule.
SUMMARY: The Interagency Testing Committee fITC) in itsTwenty-third Report to EPA recommended that EPA givepriority consideration to six chemical substances in proposing chemical testrules. To assist EPAin its determination ofwhich, ifany,tests are needed for these substances, EPA is adding the six substances to twomodel information-gathering rules: The Toxic Substances ControlAct (TSCA) section 8(a) Preliminary Assessment Information Rule (PAIR), and the TSCA section 8(d) Health andSafety Data Reporting Rule. EFFECTIVE DATE: This rule shall become effective on December 16,1988. FOR FURTHER INFORMATION CONTACT: Michael M. Stahl, Director, TSCA Assistance Office (TS-799). Office of Toxic Substances, Environmental Protection Agency, Rm. EB-44,401 M St., SW., Washington, DC 20460, Telephone: (202-554-1404), TDD: (202-554-0551).
SUPPLEMENTARY INFORMATION: This rule adds six chemical substances to the PAIR and the section 8(d) Health and Safety Data Reporting Rule. Manufacturers, processors, 'and importers ofthese chemicals will be required to report end use, exposure, volume, and unpublished health and safety data to the Agency.

Public reporting burden for this collection of information isestimated to average 32.7 hours perresponse, including timeforreviewing instructions, searching existing data sources, gathering and maintaining the data needed,and completing and reviewing the collection ofinformation. Send comments regarding theburden estimate or any other aspect ofthis collection ofinformation, including suggestions forreducing this burden, to Chief,Information Policy Branch, PM223, U.S. Environmental.Protection Agency,401 MSt., SW., Washington, DC 20460; and to theOffice ofInformation and Regulatory Affairs, Office of Management and Budget, Washington, DC 20503. I.Background Section 4(e) of TSCA established the ITC and authorized itto recommend to EPA chemical substances and mixtures (chemicals) tobe given priority consideration inproposing chemical test rules. For some ofthese chemicals theITC 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 Registerits
reasons fornotdoing so. Forthe remainder of the recommended substances, no time limit forAgency response is imposed.

Elsewherein today's issue ofthe Federal Register,EPAis announcing the receipt ofthe Twenty-third Report ofthe ITC, which wastransmitted to EPA on November 1198&The Twenty-third Report revises and updates the Committee's priority list ofchemicals and adds six substances to the section 4(e) priority list.This rule adds these six substances to thePAIRandthe section 8(d) Health and Safety Data Reporting Rule whichwil requiremanufacturers, importers, and processors to report volume, enduse, exposure, and unpublished health and safety data to EPA. In addition, one chemical substance which 1iadbeen recommended withintent-to-designate by the ITCinitsTwenty-second Report, 2-Butenal, CAS No..4170-30-3. is now designated forresponse within 12 months. This revision does not'trigger any new reporting requirements because following the recommendation with intent-to-designate, 2-Butenal (also known as Crotonaldehyde), was added to the PAIR (53 FR 18211, May20,1988) and the section aid)Health and Safety Data Reporting Rule 151 FR 2890, January 22,1986), as published in the Federal Register ofMay 20, 1988 (53 R 18190).

To assistEPA in responding to the ITC recommendations, EPAhas developed two model informationgathering rules (PAIR andthesection 8(d) Health and Safety Data Reporting Rule) which provide for the automatic addition of ITCpriority list substances. Whenever EPA announces the receipt of
an ITC report,EPA may,at the same time without notice and comment, amend the two model informationgathering rules by adding the recommended substances. The amendment addingthese substances to the PAIR and theHealth and Safety Data Reporting Rulebecomes effective 30 days afterpublication.

EPAissuedPAIR under section 6(s) of TSCA (15 U.S.C. 2007(a)), and it is codified at 40 CFR Part 712. This model section 8[a)rule established standard reporting requirements for manufacturers and importers ofthe chemicals listed in the rule. These manufacturers and importers are required to submita one-time report on general volume, end use, and exposure information using the Preliminary Assessment Information Manufacturer's Report (EPA Form No. 7710-35). EPA
uses this model section 8(a) rule to gather current information on substances ofconcern quickly.

EPA issuedthemodel Health and Safety Data Reporting Rule under section 8(d) ofTSCA (15 U.S.C. 2807(d)), and itiscodified at40 CFR Part716. EPA revised thesection 8(d) model rule
on September 15,1986851 FR 32720). The section 8Jd)nmdel rule requires past, current. andprospective manufacturers, importers, and processors oflisted chemical substances and mixtures to submit to EPA copies 'andlists of unpublished health and safety studies
on the listed chemicals that they manufacture, import, orprocess. These studies provide EPA with useful information andhaveprovided significant supportforEPA's decisionmaking under TSCA sections 4, 5, 6, 8, and 9, IL Chemicals to be Added

The following ITCpriority list substances forwhich reporting i's required under 40CFR Parts 712 and 716
are listed by ITCdesignation in ascending Chemical Abstracts Service Registry Number (CAS No.) order:

A. Designated forresponsewithin 12 months: CAS No.andVame 4170-30-3 2-Butenal (alsoknown as

Crotonaldehydej B.Recommended withIntent-toDesignate: CAS No. andName 115-96-8 Ethanol,'2-chloro-, phosphate

(3,1) (alsoknown as Tris(2- chloroethyl)-phosphate) 6145-73-9 1-PropanoL 2-chloro-,

phosphate [3:1) (also known as Tris[2- chloro-1-propyl)phosphate) 13674-84-5 2-Propanol, 1-chloro-,

phosphate 13:1) (also known as Tris(1- chloro-2-propyl)phosphate) 13674-87-8 2-Propanol, 1,3.dichloro-,

phosphate (3a1) (also known as Tris(1,3-diclloro-2-propyl}phosphate) 33125-80-9 Phosphoric acid, 1,2-

ethanediyl tetrakis(Z-chloroethyl) ester (alsoknown as Tetrakis(2- chloroethyl)ethylene disphosphate).468 eea eitrIVl.5,N.21I dedy Novembe 16 98/Rlswn euain
C. Recommended without being designatedforresponsewithin12 months:
CAS No. andname 123-72-8 Butanal (also known as

Butyraldehyde). III. Reporting Requirements
A. PreliminaryAssessment Information Rule All persons who manufactured or imported the 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 mustbe completed for each substance and submitted to the Agency no later than February 14, 1989. Persons who have previously and voluntarily submitted a Manufacturer's Report to the ITC orEPA should read §712.30(a)(3). This section allows these persons to submit a copy of the original Report to EPA orto notify EPA by letter oftheir desire to have this submission accepted in lieu ofa current data submission.

Complete details ofthe reporting requirements, including exemptions and
a facsimile ofthe reporting form, are fully described in 40 CFR Part 712. Copies ofthe form are available from the TSCA Assistance Office at the address which procedes Unit I.
B. Healthand Safety Data Reporting Rule

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

1.Persons who, in the 10 years proceding the date a substance is listed, either have proposed to manufacture, import, or process, orhave manufactured, imported, or processed, the listed substance must submit toEPA:

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, proposed to manufacture, import, or process; or are manufacturing, importing, or processing the listed substance must submit to EPA:

a. A copy ofeach health and safety study which is in theirpossession at the time the substance is listed.

b. A list ofhealth and safety studies known to them but not in their possession at the time the substance is listed.

c.A list ofhealth and safety studies that are ongoing at the time the substance is listed and arebeing conducted by orfor them.

d. A list ofeach health and safety study that is initiated after the date the substance is listed and is conducted by
orfor them.

e.A copy ofeach 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, orprocess the listed substance must submit to EPA:

a. A copy ofeach health and safety study which is in their possession at the time they propose tomanufacture, import, orprocess the listed substance.

b. A list ofhealth 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 ofhealth 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 ofeach 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 ofeach health and safety study that was previously listed as ongoing or subsequently initiated and is
now complete-regardless ofthe completion date.

Detailed guidance forreporting unpublished health and safety data is provided in the section 8(d) Health and Safety Data Reporting Rule published in the Federal Register ofSeptember 15, 1986 (51 FR 32720) (40CFR 716.60). Also found there are the reporting exemptions.
C. Submission of PAIR Reports and Section8(d)Studies

PAIR reports and section 8(d) health and safety studies must be sent to: TSCA Document Processing Center (TS-- 790), Office ofToxic Substances, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. ATTN: (insert either PAIR or 8 (d) Reporting).
D.Removal ofChemicals From the Rules Any person who believes that section 8(a) or (d) reporting required by this rule is unwarranted, shouldpromptly submit to the Agency in detail the reasons for that belief. EPAmay then remove the substance from the rule,EPA will issue
a rule amendment forpublication inthe Federal Register. IV. Release of Aggregate Data The Agency will follow procedures for the release of aggregate statistics as prescribed in a rule related notice published in the Federal Register ofJune 13,1983 (48 FR 27041). Included in the notice are procedures for requesting exemptions from the release of aggregate data. Exemption requests concerning the release ofaggregate data

on any chemical substance must be received by EPA no later than February 14, 1989.
V. Economic Analysis A. PreliminaryAssessmentInformation Rule

EPA estimates the PAIR reporting cost of this rule is $33,635. To calculate this figure EPA used the TSCA Inventory to generate a list ofmanufacturers and importers ofthese substances. Since no companies qualify as small businesses

as defined in 40 CFR 712.25(c), EPA expects thirteen firms to report a total of twenty-five reports.

Reporting cost (dollars:

(a) 25 reports expected at $8071

report

.......... .......................... (b) 20 familiarization cases at

$673/case

.........................................

Total

................. .................. Average cost per site

............................... Average cost per firm

.............................. Reporting burden (hours):

(a)familiarization: 18 hours pet site

x 20 sites

......................................... (b)reporting: 16 hours per report X

25 reports

..........................................

Total (hours)

. ... . ............. EPA cost:

Processing Cost = 25 reports x

$91/report....................... $20,175
13,460 33,635 $1,681 2,587

360

400
760

$2,275

B.Health andSafety Data Reporting Rule EPA estimates the total reporting costs for establishing section 8(d) reporting requirements forthese substances is $19,680. This cost estimate is relatively 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 data is not current. Therefore, EPA intends to overestimate rather than underestimate thereporting burden.

Nevertheless, the cost ofthis rule is low in comparison with itspotential benefits. Health and safety studies concerning these substances would improve EPA's abilityto identify potential public health and environmental problems with regard to these chemicals. The Agency therefore 46280 Federal Registar / Vol, 53, No. 221 / Wednesday, November 16, 1988 / Rules and RegulationsFederal Register / Vol. 53, No. 221 / Wednesday, November 16, 1988 / Rules and Regulations 46281

would be better able to determine whether further regulatory action would be necessary.

The estimated reporting costs are broken down as fullows:

Initial corporate revlew

.............. $3,510 Site identification

...................................... 2,430 Fife searches at affected sites

............... 5,022 Title listing _. ............................ 252 Photocopying

......................................... . 842 Managerial review

......... .. 48860 Reporting on newly-initiated studies 120 Submissions after initial reporting

period

............................................... 2,060 Total

................................................ 19,680

VI. Rulemaking Record

The following documents constitute the record for this rule (docket control number OPTS-84029). All ofthese documents are available to the public in the TSCA Public Docket Office from 8

a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The TSCA Public Docket Office is located at EPA Headquarters, Rm. NE-G04, 401 M St., SW., Washington, DC.

1. This final rule. 2. The economic analyses for this rule. 3. The Twenty-third Report ofthe ITC. VII. Regulatory Assessment Requirements
A. Executive Order12291

Under Executive Order 12291, EPA mustjudge whether a rule is "major" and, therefore, subject to the requirement ofa Regulatory Impact Analysis. This rule is not major because it will not result in an effect on the economy of$100 million or more, an increase in costs orprices, or any ofthe adverse effects described in the Executive Order.

This amendment was not submitted to the Office ofManagement and Budget (OMB) for review, because the automatic listing of designated substances is provided for in 40 CFR 712.30(c) and 716.18(b)-final rules which have been previously reviewed by OMB under the terms of the Executive Order. B.Paperwork ReductionAct The information collection requirements contained in this rule have been approved by OMB under the provisions ofthe Paperwork Reduction Act, 44 U.S.C. 3501 etseq.and have been assigned OMB control numbers 2070-0054 and 2070-0004.

Public reporting burden forthis collection of information is estimated to average 32.7 hours per response, including time forreviewing instructions, searching existing data sources, gathering and maintaining'the data needed, and completing and reviewing the collection ofinformation.

Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions forreducing thisburden, to Chief,Information Policy Branch, PM223, U.S. Environmental Protection Agency, 401 M St., SW., Washington, DC 20460; and to the Office ofInformation and Regulatory Affairs, Office of Management and Budget,Washington, DC 20503, marked "Attention: Desk Officer for EPA." List ofSubjects in 40 CFR Parts712 and 716

Chemicals,Environmental protection. Hazardous substance, Health and safety data, Recordkeeping and reporting requirements.

Dated: November 4,1988. Joseph J.Merenda, Director, Existing ChemicalAssessment Division,OfficeofToxic Substances.

Therefore, 40 CFR Chapter Iis amended as follows:
PART 712--AMENDED]

1.The authority citation forPart 712 continues to read as follows:

Authority: 15 U.S.C. 2607(a). 2. Section 712.30 is amended by adding the following substances to paragraph (w)in CASNumber order as follows: 

### §

712.30 Chemical lists and reporting periods.

w* * * 

### (w) * * *

Effective Reporting CAS No. Substance date date

115-96-8 Ethanol, 2-chioro-, phosphate (3:1)...........................................................................................................................................

... 12/16188 2/14/89

123-72-8 Butanal

................ ............................... . ................................................................................ ........................................................... 12/16/88 2/14/89

6145-73-9 1-Propanol, 2-chloro-, phosphate (3:1)

.............................................................................................................................................. 12/16/88 2/14/89

13674-84-5 2-Propanol, 1-chloro-, phosphate (3:1)

.............. ........................................................... 12/16/88 2/14/89 13674-87-8 2-Propanol, 1,3-dichloro, phosphate (3:1)

............................................. rh

.................................................................................. 12/188 2/14/89 33125-86-9 Phosphoric acid, 1,2-ethanediy tetrakis(2-chloroethyl) ester

........................................................................................................... 12/16188 2/14/89

(Approved by the Office of Authority: 15 U.S.C. 2607(d). §716.120 Substances and listed mixtures Management and Budget under control 2. By adding substances to §716.120(a) to which this subpart applies.
number 2070--0054.) numerically by CAS Number to read as PART 716--AMENDED] follows: (a) * * *

1. The authority citation for Part 716 continues to read as follows:

CAS No. Substance Special Effective Sunset date exemptions date

Ethanol, 2-chloro-, phosphate (3:1)

.................................................................................................................................................. 1 115-96-8 12116/88 12/16/9846282 Federal Register / Vol. 53, No. 221 / Wednesday, November 16, 1988 / Rules and Regulations

CAS No. Substane Special Effective Sunset date exemptions date

* e a * a a a 123-72-4 Butansl

.................................................. ....... .......................... ........................ 12/6188 12/16/98

6145-73-9 1-Propanol, 2-chloro-, phosphate (3:1)

........................................................................................................................................... 12/16/88 12/16/98

13674-84-5 2-Propanol, 1-chloro-, phosphate (3:1)

.............................................................................................................................................. 12/16/88 12/16/98 13674-87-8 2-ProPao, 1,3-dichloro-, phosphate (3:1)

....................................................................................................... ......................... 12/16/88 12/16/98 33125-86-9 Phosphoric acid, 1,2-ethanediyl tetralks (2-chioroethyl) ester

.................................................................. ......................... 12/16/88 12/16/98

• a • a * a a

(Approved by the Office of Management and Budget under control number 2070-0004.) [FR Doc. 88-26305 Filed 11-15-68; 8:45 am)
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