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Citation: 53 Fed. Reg. 51698 1988

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### 5No. 246 / Thursday, December 22, 1988 / Rules and Regulations

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 704 [OPTS-82013C; FRL-3368-1
Comprehensive Assessment Information Rule

AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule.
SUMMARY: EPA is promulgating a standard approach to gathering information on the manufacture, importation, and processing ofchemical substances and mixtures under section 8(a) ofthe Toxic Substances Control Act (TSCA). This standard approach, or model rule, titled the Comprehensive Assessment Information Rule (CAIR), establishes uniform reporting and recordkeeping requirements and a list of questions from which specific information requirements will be assembled on a substance-by-substance basis. This rule will be used to obtain information needed by EPA and other Federal agencies to support the
assessment and regulation ofchemical substances and mixtures. EPA is also establishing specific reporting requirements for 19 substances at this time. Future additions ofsubstances will be made through amendments to this rule announced in the Federal Register. DATES: In accordance with 40 CFR 23.5 (50FR 7271), this rule shall be promulgated for purposes ofjudicial review at I p.m. eastern time on January 5,1989. This rule shall become effective

on February 6, 1989.
FOR FURTHER INFORMATION CONTACT. Michael M.Stahl, Director, TSCA Assistance Office (TS-799), Office of Toxic Substances, Environmental ProtectionAgency, Rm. EB-44, 401 M St., SW., Washington, DC 20460. Telephone: (202) 554-1404. Hearing Impaired: TDD (202) 554-0551.
SUPPLEMENTARY INFORMATION: In this rulemaking, EPA is establishing a standard approach to gathering information on the manufacture, importation, and processing of substances. This standard approach, or model rule, is called the Comprehensive Assessment Information Rule (CAIR). It establishes uniform reporting and recordkeeping requirements that can be adapted to specific substances and a standardized reporting form. Thisrule will reduce duplicative reporting by industry and conserve EPA resources.

Public reporting burden forthis collection ofinformation is presented in chart form inUnit XII.C. ofthis preamble. These estimates include time forreviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection ofinformation. To locate a respondent's burden estimate on the chart, identify the substance's Chemical Abstract Service (CAS) Registry Number and the respondent category forwhich the report is being submitted, and locate the corresponding range. Send comments regarding the burden estimate or any other aspect ofthis collection of information, including suggestions for reducing this burden, to Chief, Information Policy Branch,PM-223, U.S. Environmental Protection Agency, 401 M St., SW., Washington, DC 2040; and to the Office ofInformation and Regulatory Affairs, Office ofManagement and Budget, Washington, DC 20503, marked "Attention: DeskOfficer for EPA"

I.

Authority
Section 8(a) ofthe Toxic Substances Control Act (TSCA) authorizes the Administrator ofEPA to promulgate rules thatrequire manufacturers, importers, and processors ofchemical substances and mixtures (referred to hereafter as substances or chemical substances) to maintain records and submit information on such substances

as the Administrator may reasonably require.Failure to comply fully with any provision ofa section 8(a) rule is a violation ofsection 15 ofTSCA and subjects the violator to penalties under TSCA sections 16 and 17.

II. Background
A. Proposed Rule
The proposed rule was published in the Federal Register ofOctober 7, 1986 (51 FR 35762). Recognizing the wide scope ofthis rule and the comment period overlap with another major reporting rule, the Agency extended the
comment period for an additional 60 days (for a total of150 days) to allow sufficient time forthoughtful comment.

Extensive comments were received from thepublic during this time period. A briefdiscussion ofthese comments and the changes made to the rule in response to these comments is found in each section ofthepreamble that addresses that particular aspect ofthe rule.

TheAgency has also prepared a more detailed discussion ofthe comments and EPA responses in a document titled "Response to Comments" that is in the public record for this rule.Also included in this record are theresults ofa pre-test ofthe reporting form conducted by the Agency during the comment period. B.Description of

Rule

The CAIR has generic reporting and recordkeeping requirements and a standard list ofquestions.The main objective ofthe CAIR is to obtain
necessary information in a timely fashion while conserving industry and EPA resources. The CAIR will accomplish this objective by: (1) reducing duplicative reporting by industry, (2)reducing familiarization time for industry responding to reporting requirements, and (3) reducing Agency

resources needed to develop information-gathering rules and process thedata reported.

It isEPA's intention to amend the CAIR from time-to-time through regular notice and comment rulemaking for purposes ofadding substances to the rule. Unless absolutely necessary, no other changes will be made to the regulatory text or the CAIR form. Amendments will identify the substances forwhich there is an information need, the information requested, theretrospective period covered by therule, and the categories ofpersons who must provide the information. Only those questions and reporting requirements listed in the amendments must be complied with. For example, EPA may require manufacturers and processors of substance "X" to respond to all of the questions in Section Iplus questions 2.03, 3.05, and 4.05 in the reporting form, while manufacturers and processors of substance "Y" might be required to

answer all ofthe questions in Section 1 plus questions 2.03, 5.06, 7.03, and 7.05. Hereafter, when discussing amendments to the CAIR, the Agency is referring to amendments that will add chemical substances to the rule butnot alter any other parts ofthe regulatory text,unless otherwise stated.

C.Intentof Rule

EPA is promulgating the CAIR as an improved method for gathering and maintaining information on substances relevant to chemical risk identification, all stages ofrisk assessment, and control action functions. By using a uniform format and set ofquestions, both EPA and industry can reduce time and resources usually associated with the varying formats oftraditional chemical-specific rules. In the same way, errors in reporting and interpretations ofthe type of data being requested can be reduced through experience with a modelrule. The standardized format proposed in the CAIR will allow EPA to have a single data base for easy storage and retrieval, 

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and will allow industry the same benefit.

Generally, regulatory agencies gather information to support the assessment and management ofchemical risks through a lengthy and costly process. First, an agency determines that a particular substance under certain circumstances maypresent a risk to health or the environment. The agency then gathers readily available information about that substance to determine possible courses ofaction. This informationmay support a determination that regulatory action is appropriate, but precise information is usually needed to determine whether and towhat degree regulation is required. Since this information is held by chemical substance manufacturers, importers, and processors and is not publicly available, the agency must use its statutory authority to gather the information.

This requires that the agency draft and issue a proposed rule, review public comments, draft and issue a final rule, and establish and maintain a data base

on thereported information. During this time the agency must either delay taking risk management action or take action without complete information. Because each information-gathering rule usually has unique reporting requirements, the agency also has to respond to numerous questions following each new rule's promulgation.

Information-gathering rules may also be costly to the companies submitting the information. Foreach proposed rule, potential respondents review the requirements and, ifnecessary, submit
comments. Following promulgation, the companies familiarize themselves with the final reporting requirements, locate the information in company files, complete the reporting forms, and submit them to the agency.

EPA's experience with model rules has shown that model rules offer several advantages for both EPA and respondents. ForEPA, the advantages

are: (1)the time to promulgate an amendment that adds chemical substances to a model rule is onequarter to one-third the timeneeded to publish a chemical-specific rule; (2) Agency review can concentrate on the need for information and the information request since reporting and recordkeeping requirements are standardized; (3) more efficient handling and review ofcompleted forms due to standardization; and (4) a single, universally accessible data base is possible for storage and retrieval of information.

For respondents, model rules offer the advantage ofcertainty. No matter the substance, many ofa respondent's reporting and recordkeeping obligations

are standardized, including the use of the same reporting form. This reduces familiarization time and reporting costs. Also, EPA's experience with a model rule has shown that as respondents repeatedly use a form, correct errors, and resubmit the form, significantly fewer errors occur. Thus, with model rules, the cost to respondents of resubmitting reporting forms is reduced. It also ensures that the Agency can
access a complete and accurate data base more quickly, rather than waiting for corrections to be made.

D. The CAIR andOtherSection (a) ModelRules

EPA designed this rule by building on its experience with two existing section 8(a) regulations: the TSCA Inventory Update Rule (IUR) (40 CFR Part 710, Subpart B; 51 FR 21438; June 12, 1986) and the Preliminary Assessment Information Rule (PAIR) (40 CFRPart 712; 47 FR 26992; June 22,1982). The TSCA IUR requires manufacturers and importers ofcertain chemical substances to provide EPA with basic identification, production, and sitelimited status information every 4 years. Questions requesting the same information havebeen added to Section 1ofthe CAIR reporting form and would be answered by persons subject to the CAIR.EPAhas included an exemption in the IUR to ensure that a company reporting for the CAR would nothave to report for the IUR (40 CFR 710.35). Under this exemption, persons who mustreport forthe CAIR are not required to submit subsequent fUR reports so long as the CAIR reporting occurred no more than Iyear prior to the period forwhich IURreporting is required.

The Agency also designedthe CAIR reporting form to include questions similar to those in the PAIR. Three basic differences existbetween the PAIR and the CAIR: (1)only manufacturers and importers are subject to the PAIR, whereas processors are alsopotentially subject to the CARl; (2) under thePAIR, respondents are required to answer every question in the PAIR (EPA Form 7710-35), whereas the CAIR listsonly the specific questions (from the entire form) that mustbe answered; and (3) whereas thePAIR form contains only basic questions on production, use, and exposure that can support preliminary"
assessments ofchemical substances, the CAIR includes more detailed information designed to support all' stages ofassessments.

Substances are added to the PAIR by (1)notice and comment rulemaking or (2)adding a substance to the rule automatically without notice and
comment and requiring reporting within 90 days. Only substances identified by the Interagency Testing Committee (ITC) under TSCA section 4(e) are added automatically.

Under the CAIR, any EPA program office requesting basic PAIR-type information on a substance can use the CAIR to gather this information. Such additions ofsubstances will be made through regular notice and comment rulemaking. TheAgency is planning to amend the CAR, at some future date, to add the ITC automatic reporting provisions. EPA will at that time withdraw the PAIR. However, until that time,ITC identified substances will continue to be added to the PAIR.

Although not issued under the authority ofTSCA section 8(a), the Superfund Amendments and Reauthorization Act (SARA) Title III, section 313 rule which was published in the Federal Register ofFebruary 16, 1988 (53 FR 4500), has some similarities to the CAIR. Like the CAM,the SARA section 313rule requires manufacturers, importers, and processors to report exposure-related information on listed substances. Unlike the CAIR, SARA section 313 requires annual reporting on every substance listed in the rule unless

a substance is removed from therule. To minimize theburden on companies that may have to report for both rules, EPA has purposely staggered the reporting periods for the first round ofreporting and will seek ways tominimize reporting overlap in the future. Further, any substance listed on the SARA section 313 rule and also on the CAIR, will not be subject to duplicative reporting. That is, those questions on the CAIR that directly overlap questions on the SARA section 313rule will not be asked under the CAIR for any substances that are on both rules. Data received on those substances which are
on both rules will be shared between EPA's Office ofToxic Substances (OTS) and EPA's Office ofSolid Waste and Emergency Response (OSWER), as well

as EPA's Office ofAir and Radiation and Office of Water.

Also, ifEPA has collected accidental release information under the Agency's Accidental Release Information Program

on a substance being considered for the CAIR, questions which are duplicative ofor similar to that information will not be askedunder the CAIR. In addition, EPAwill consider whether the information requested, ifnot already available, could be gathered more efficiently or accurately Under the No. 246 / Thursday, December 22, 1988 1 Rules and Regulations 51699 Federal Register / Vol. 53,

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Accidental Release Information Program than under the CAIR. 111. The Final Rule
A. An Overview

To be consistent between other TSCA section 8(a) rules and the CAIR, EPA consolidated and incorporated many requirements found in other parts ofthe CFRinto Part 704.Part 704provides the framework for all section 8(a) rules and is amended as follows: The current general provisions for all TSCA section 8(a) rules apply to all section 8(a) chemical-specific rules and,unless otherwise stated, to the CAIR. Subpart A ofPart 704 contains the general reporting and recordkeeping provisions. Subpart B listschemical-specific section 8(a) rules. The regulatory text that specifies the general provisions of the CAIR is located in Subpart C, and Subpart D contains thereporting period deadlines and a matrix thatlists the substances forwhich there is an information need, the information requested for each substance, theperiod covered by the rule, thepersons who
must provide the information, exemptions added or removed, and the effective date ofthe final rule.

The sub-units under Unit B below correspond to the requirements in the CAIR matrix (SubpartD ofthe rule). Each sub-unit describes a requirement in the rule, and the last subunit explains how these requirements are listed in the matrix. Directions for obtaining the CAIR reporting form and instructions

are givenin Unit F. B.ReportingRequirements
1. Who Must Report

For the 19 substances listed in this final rule, and whenever EPA adds a substance to the rule, the Agency states who is required toreport on each substance (manufacturers, importers, and/or processors) and which previous years are covered by therule. Manufacturing activities are all those activities at one site which are necessary to produce a listed substance and make it ready for sale oruse as the listed substance, including purifying and importing a substance. Processing activities, on the otherhand, Include (1)

use ofa listed substance after its manufacture to make another substance for sale oruse, (2) repackaging of the listed substance, or (3)purchasing and preparing the listed substance for use or distribution in commerce. Therefore, under the CAIR, all ofthe steps involved in making a CAIR listed substance, including adding stabilizers and additives, which are necessary to get the substance "out the door" or ready for

use, are considered part of manufacturing. Persons who are required to report must answer the CAIR reporting form questions only for the activity that is designated in the rule. For instance, if EPA were to require manufacturers ofa substance to report, then a person who both manufactures and processes the substance would nothave to answer the CAIR questions forboth activities, only for the manufacturing activity; however, ifboth were required, the company would report on both activities using the

same form.

For some ofthese listed substances, EPA is requiring processors other than the original manufacturer or importer to report. However, sincemany manufacturers, importers, and
processors market the listed substances to these "customers" under names other than a systematic oreasily recognizable chemical name (i.e., the substances are sold under trade names), persons who buy andprocess the substance under a trade name may notrealize that the substance is listed on the CAIR and that they are required to report. Under the CAIR, EPA considered two approaches forgathering information from
customers who process a listed substance. Thefirst approach wasto list the substances in the Federal Register by chemical name and require all processors ofcertain substances to report.Under this option, however, the Agency would expect to receive reports from only those persons whoknow or
can reasonably ascertain that they are processing the listed substance. EPA has therefore chosen to adopt the second approach.

This reporting/notification mechanism, listed in §704.208 ofthe CAIR, requires thosepersons who manufacture, import,or process a listed substance and distribute that substance under a trade name, to do one ofthree things: report fortheir customers who process the listed substance; notifytheir
customers that the trade name substance is listed by EPA and that the
customers mustmeet EPA reporting requirements; orprovide EPA with the trade name.

Persons mayreport for their
customers whoprocess a listed substance onlyifthey can supply the requested information. Suchreporting is due no later than thereporting period deadline for that substance listed in §704.223(a). All reporting requirements that apply to a customer who processes the listed substance would then apply to the person submitting the report on behalfof the customer. Such persons are liable forinformation they report incorrectly on their customers' activities just as the customers would be for reporting incorrectly on their own activities.Persons who sell a listed substance under a trade name and who

are either unable to report for their
customers or who choose not to do so

are required to comply with one ofthe other options.

Manufacturers, importers, or processors may choose to notify, in writing, their customers who are subject
to reporting andinform them of the specific section in Subpart D that identifies the substance and the processor reporting requirements. The
customers whoprocess the substance prior to the effective date ofthe listing of the substance must be notified by certified mail no later than 30 days after the effective date ofthe listing ofthe substance. The customers must then report to EPAwithin the time period specified in §704.223(b) of thereceipt of thenotification. Persons who notify their
customers of theirreporting obligation must also inform them of the date such reporting is due, and the citation ofthe Federal Register that promulgated the reporting requirements on the listed substance.

Manufacturers, importers, or processors who do not wish to report for their customers ornotify them oftheir reporting obligations must, by I day after the effective date ofthe rule listing the substances, submit theirtrade

names to EPA (to the same address as the reporting forms). These submissions
must contain, at a minimum, the company's name and address, the address and telephone number of the company's technical contact, the chemical name and CAS number of the substance as listed in the rule, and the trade names under which the substance is marketed. The submitter must indicate that the submission is in response to a CAIR Federal Register notice.

Once the trade names are received, EPA will issue a technical amendment adding the trade names to thefinal rule. This amendment will be published in the Federal Register within4 weeks after the rule has become effective, and the processors ofthese trade name substances would then have to submit their reports by the deadline specified in the reporting period for that amendment.

The following diagram graphically depicts the reporting schedule foreach of the three customer reporting/ notification options. Since thereporting period for the substances listed in this final rule is 90 days from the effective date ofthe final rule, the 90-day period is used in the example. Future amendments may have different reporting periods.

ILLNG CODE 5SO-50-

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SCHEDULES FOR CUSTOMER REPORTING/NOTIFICATION OPTIONS



### Persons Who Choose To Report For Their Customers:



## Publication
Date Effective
Date

------------------------------ 90 Days----------

(2) Persons Who Choose to Notify Their Customers:



## Publication Date Effective
Date Notify 

## Customers 

## Customers Report



## I---------------I---30 Days---- I--90 Days------- I

Persons Who Choose To Submit Trade Names To EPA:



### Publication
Date Submit Trade
Names EPA Publishes Trade Names 

## Customers Report

I--Effective Date + 1 day--l--4--Weeks-- ----- 90 Days----- I

BILLING COO 6560-50-C 

## (1)

Reports Due



## (3) 61701

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.In theproposed CAIR, EPA requested comments on this customer reporting/ notification mechanism and suggestions foralternate information gathering approaches. No substantive suggestions for an alternative mechanism were received. Therefore, the Agency will use the scheme as proposed. Tominimize the burden ofthis requirement, the Agency has extended the time period for notifying customers forthose persons who choose this option.The proposed rule had set a 10-day time limit; this final rule extends the periodto 30 days. EPA will reevaluate thisprovision and may reduce orfurther extend the 30-day period for subsequent CAIR iterations.

Persons who choose the customer notification option, but who cannot meet the deadline, mayrequest an extension oftime.Extension requests mustbe in writing,justify the needfor the extension, and be postmarked no less than 5days prior to the notification deadline.

Some commenters to theproposed rule suggested that the definition of "customer" was too broad in that it includes disposal facilities and persons who purchase articles.These commenters felt that such persons should notbe included under the CAIR and thatmanufacturers and processors should notbe responsible for notifying themor reporting for them.The Agency has decided to leave the definition as proposed. Since persons who import or process a listed substance as part ofan article are exempt from this rule, the persons who sell these articles are not responsible fornotifying their customers whoprocess the articles.

The Agency does not agree that persons who operate disposal facilities should be excluded from CAIR reporting; processing ofthe listed substances at a disposal facility can present a significant potential for exposure about which EPA orother agencies may require information.

2. Exemptions From Reporting

Persons who manufacture, import,or process a listed substance are subject to this ruleunless they meet one ormore of the standard exemptions setforth in §§704.5 or 704.210. The following persons are exempt, unless the exemption is made inapplicable on a substance-by-substance basis: (1)small manufacturers (total annual parent sales

are less than 40 million dollars and the company manufactures less than 100,000 pounds at a plant site, ortotal annual parent company sales less than 4 million dollars); (2] processors and importers of articles; (3) manufacturers, importers, and processors ofsubstances that are manufactured, imported, orprocessed solely as impurities or byproducts; (4) manufacturers, importers, and processors ofresearch and development substances; and (5) manufacturers of nonisolated intermediates. Whenever EPA intends to change any or all of these exemptions for reporting on a particular substance, the Agency will

use notice and comment rulemaking and the change in the exemption will be noted in the matrix in Subpart D of the CAIR. Two new exemptions, which are discussed below, havebeen added to 

### §704.210 in Subpart C.

EPA, underthe CAIR, is requiring processors toreport; however, processors who are either small or are solely repackagers would be exempt from reporting. A processor is exempt if (a)total annual parent company sales

are less than 40 million dollars and the company processes less than 100,000 pounds ofa listed substance at a plant site; or (b) ifa processor has total annual parent company sales of less than4 million dollars. These sales and volume limits are the same limits EPA

uses to define smallmanufacturers. Like the small manufacturer exemption, EPA intends to revise the sales figures periodically based on the Producer Price Index forChemicals and Allied Products.

The small processor exemption uses the same size limitations as the small manufacturer exemption because: (1) in the aggregate, forthe chemical industry in general, the sales and quantities produced orprocessed are approximately the same for manufacturers and processors, and (2) many manufacturers are also processors and therefore are potentially subject to CAIR reporting foreither orboth activities. Consistent standards for both willresult in an insignificant information loss and will minimize confusion forrespondents.

EPAis also exempting processors who

are solely repackagers. A repackager is defined as a person who buys a listed substance or mixture, removes the substance or mixture from the container in which itwas bought, and transfers this substance, as is,to another container for sale. The Agency has determined that requiring such reporting would greatly expand the scope ofCAIR (i.e., the numberof persons who must report) without significantly adding to the quality ofthe data reported. Persons who engage in processing activities other than repackaging must report. Moreover, since repackagers, by definition, are preparing a substance for further use, those persons who buy the repackaged substance and process it further will still be required to report, unless they are users of the substance. Thus, EPA, in most cases, will be able to track a.substance through commerce,
even ifrepackagers do not report.The Agency will re-evaluate this exemption in the future to determine whether it excessively limitsthe reporting of significant data.

Ifany ofthe exemptions stated above

are changed in the rule fora particular listed substance, the Agency will indicate this by listing the exemption citation in the matrix and preceding it with a minus sign 

### (e.g., "- §704.210"). Exemptions that are added for the first time to the CAIR will be listed inthe matrix next to the substances to which they apply and will be indicated by the citation preceded with a plus sign.
3. Coverage Period

As with the other requirements described in Unit IIL.B. ofthe preamble, the dates when a company was engaged in manufacturing, importing, or processing a CAIRlisted substance will help determine whether the company has to report or not.The dates mustbe during a complete corporate year that occurred during the "coverage period" identified with each substance in Subpart D. The coverage period is a time span that is Iday less than 2 years; thus, no company can have more than

one complete corporate year in any one coverage period.

An example ofhow the coverage period works is as follows. EPA issues a CAIR amendment with an effective date ofNovember 7, 1989; the rulerequires manufacturers ofchemical Ato report. The coverge period is from November 8, 1987 to November 6, 1989. Ifa company has a corporate year from January Ito December 31 and begins manufacturing chemical.A on May 27,1989, the company does not have to report. Even though the company was making the CAIR substance during the coverage period, no manufacturing activity occurred during the complete corporate fiscal year which falls within the coverage period (January 1,1988 to December 31, 1988).

With each substance added to the CAIR, EPA will identify one or more coverage periods. When more than one coverage period is identified with a substance, the most recent coverage period will be listed first,the next most recent second, etc. The most recent coverage period loosely corresponds to what EPA called "current reporting" in the proposal; the other periods were called "past reporting." Many commenters to theproposed rule stated

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that requiring reporting on activities that occurred in past years (i.e., past reporting) would be difficult for some companies since (1)theymay have gone out ofbusiness, and (2)personnel who

were engaged in these activities and files on these activities may no longer be available.

EPAhas decided to continue its requirement as proposed, although in a different formatfor coverage periods. Although EPA will continue torequire reporting on some substances with past coverage periods, persons subject to these past requirements would only be responsible for completing Section Iof the CAIR reporting form; however, any question on the CAIR form may be asked forcurrentcoverage periods. Further,companies that were engaged in reportable activities for more than one coverage period, would only be required to report for the most recent coverage period. In addition,EPA will include no

more than two past coverage periods, plus the current coverage period, for any
one substance, thereby minimizing the burden on companies subject to past or multiple coverage periods.

The Agency decided to keep some past reporting in the CAIR since ifall such reporting were eliminated, batch manufacturers that didnot produce a listed substance during the current coverage period would notbe required to report, and the degree ofpast exposure would be underestimated.

For thepurposes ofthe CAIR, EPA requires reporting only ifpersons currently manufacture orprocess chemical substances for commercial purposes. Thus, companies that manufactured orprocessed a listed substance in the past,butwho are not manufacturing or processing any chemical substances as ofthe effective date of therule or rule amendment listing a substance, are not subjectto reporting. Companies that are subjectto the rule who engaged in reportable activities only during a past coverage period are to report only that information known to them or reasonably ascertainable by them. Thus,

some companies that cannot reconstruct data for past reporting can state that the data are unknown.

In the proposed rule EPA included requirements not only for activities that occurred in thepast but also for activities that may occur in the future. Many comenters questioned the Agency's ability to determine now what its information needs will be in the future. Further, they argued that EPA should first review the data submitted during the initialreporting period before requiring subsequent reporting. The Agency agrees. EPA will wait to propose subsequent reporting until after initial reporting requirements arereceived and reviewed. Ifsubsequent reporting is deemed necessary, EPA will propose and promulgate these requirements.

The Agency believes that waiting to issue additional reporting requirements until initial data have been submitted will be beneficial to all parties. Under the proposed approach, many years may have elapsed between the proposal of additional reporting requirements and the date when actual reporting is required, For example, some substances in the October 7,1986,proposal had +5 designations. This means that ifthe effective date forinitial reporting was October 1,1988, future reporting would notbe due until 90 days after October 1, 1993. During the period between the proposed and final rule, new information may become available to the Agency orthe public that might lessen oreliminate the needforthe CAIR data.
4. Question Selection

The question selection section ofthe rule specifies which questions from the CAIR reporting from mustbe answered for specific substances. Each person subject to the rule need only answer those questions designated forhis orher substance.

The question selection requirement will always include Section I ofthe reporting form. Other questions and sections ofthe form willbe requested on
an as-needed basis. These requirements will be listed in the CAIR matrix by the section orquestion number from the CAIR reporting form. Whenever the question selection lists a section in the CAIR form, each person subject to that requirement must answer allparts of that section. A question selection listing might be as follows: 1, 2all, 3 all,4.01, 4.05, 5 all.The 1, 2all, 3 all, and 5 all, refer to entire sections ofthe CAIR form; the4.01 and 4.05 refer to specific questions in Section 4 ofthe form. 5. Reporting Period
All persons subject to the rule must reportno later'than the dates specified in §704.223(a) of Subpart D ofthis rule, Processors who are notified oftheir reporting obligation by their chemical suppliers must report within the time period identified in 

### §704.223(b).

Persons who cannot meet a reporting deadline can request a reasonable extension. These requests must be in writing with ajustification for the extension request, and they must be received by EPA within: 30 days after the effective datelisting the substance

or30 days after receiving notice from a chemical supplier ofthe processor reporting obligations. Some commenters suggested that EPA provide longer reporting periods because the CAIR reporting period could overlap with that of section 313 of SARA. Since the CAIR becomes effective after the close ofthe first section 313 reporting, no overlap exists.

Other commenters requested more time to report than the 60 days proposed for this rule because ofthe resource intensive nature ofCAIR reporting. The Agency has considered the comments received on the length ofthe reporting period and has decided to set a 90-day
response periodfor the substances listed in today's rule. Since the 90-day response period starts when the rule becomes effective, and the rule isnot effective until 44 days aftertoday's Federal Register publication date, respondents willhave several months to prepare their CAIR reports. However, if necessary, the Agency mayrequire a shorter response period (e.g., 60 days) in

some cases in the future. The reporting period for each CAIR amendment will be specified in the paragraph preceding the CAIR matrix ( 704.223).
6. Use of the CAIR Matrix

The CAIR matrix in Subpart D ofthis rule lists all ofthereporting requirements and any changes to the standard CAIR exemptions that may apply to eachlisted substance. The matrixlists substances, persons who
mustreport, exemption modifications,
coverage period, questions selected for reporting, and the effective date. The following sample matrix was developed
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SAMPLE MATRIX

CAS No. and chemical Who must reprt xmton de Coverage period Qluestions selectedEfetv Exemptions added (+), eid usin se Effetie

name removed

- date

56-78-9 ChemicalA.... M,X/P, I,P

.............. 5/4/86 to 5/2/88

..... 1,2.01, 2.11, 2.12, 3.04, 4 all, 6.03, 5/3/88 7.01, 8.01.

............... . M

...... 5/4/85 to5 2/87..... I

............................................................... 5/3188 2-3-5 ChemicalB

....... . .................... 5/4/86 to 5/2/88

..... 1, 2.01, 2.04 thru 2.06, 9.04 thru 5/3/88 9.07, 10.06.

M= Each Person Who Manufacturad the Substance for Commercial Purposes. I Each Person Who Imported the Substance forCommercial Purposes. P= Each Person Who Processed the Substance for Commercial Purposes. X/P = Each Person Who Manufactured, Imported, or Processed the Substance for Commercial Purposes and Distributed the Substance under a Trade Name.

As one can see from this matrix, each of the four reporting requirements is a colwun heading.The other column headings are the identification forthe listed substance (CAS Number and Chemical Name), and the effective date ofthe final rule listingthe substance. The first steppotential respondents should take is to look at the chemical list.Iftheyhave not manufactured, imported, or processed any ofthe listed substances during theprevious 3 complete corporate fiscal years, they do not have toreport for the CAIR. If,on the other hand,they have engaged in

one ofthose activities, they must read further.

The first variable that excludes a company fromCAIR reporting means that company isnot subject to reporting

on that substance.For example, ifa company processes a listed substance, but upon reading column 2learns that only manufacturers and importers are required to report, that company is not subject to reporting on that-substance.

The coverage period is the last variable that determines whether a company mustreport ornot. The company would determine the complete corporate fiscalyear which falls within each coverage period identified in the matrix and whether itengaged in a subject activityduring each coverage period. The company would then report for the most recent complete corporate fiscal year during which it engaged in a subject activity. Ifthe company did not engage in a subject activity during any coverage period, it need notreport under the CAIR. For example, using the sample matrix, suppose a company has its corporate fiscal year from January 1 through December 31, and manufactured Chemical A from August 13, 1986to May 27,1987. The company's complete corporate fiscal year which falls within the coverage period (May 2, 1986-April 30, 1988) was January 1, 1987 to December 31,1987. The company must therefore report as a manufacturer of Chemical A from January 1,1987 to May 27, 1987. Forthis activity the company is responsible for the reporting requirements in the next column (1, 2.01, 2.11, 2.12, etc.). Even though the
company also manufactured Chemical A in a past coverage period (May 2, 1985 to April 30, 1987), the company does not need toreport its activity during that period. A company need only report for the most recent reporting year applicable to them.

C. Levels of Effort

In response to the many questions and
comments received on the four "levels ofeffort" setforth in the proposed rule, and a concern for lessening the burden placed on the reporting public, EPA is eliminating the "levels ofeffort" requirement and willrequire persons to report information that is "known to or reasonably ascertainable by" them as defined in § 704.3. The "levels ofeffort" concept was conceived by the Agency to spell out more specifically what level of effort companies would need to meet their reporting obligation. However,

some commenters stated that this scheme was less clear than the "known
to orreasonably ascertainable by" standard used in previous rules. Thus, the latter standard has been-adoptedfor thisrule.

D. Recordkeeping

Under § 704.11, persons subject to the requirements ofthe rule must retain: a copy ofeach report submitted, supporting materials sufficient toverify

or reconstruct the report, and a copy of all notices sent to customers who are required to report, with return receipt cards. The report submitted to EPA and its supporting material must be retained for a period of3 years from the date of the submission ofthe report. Notices submitted to customers, including return receipt cards, must be retained 3 years from the date they were sent to the
customers. Some commenters stated that requiringrecords tobe kept more than 2
years would place a severeburden on many companies. Further, therecords that must be kept, (as set forth in the proposed rule in §704.11(b)-"all supporting material and documentation used by the person to complete each report") were viewed by the
commenters as too inclusive and

resource intensive to maintain.

EPA has reviewed the typical schedules for compliance inspections to determine the appropriate length oftime CAIR records must be retained so that they will be available during an inspection. Based on this analysis, the Agency has determined that a period of 3 years is necessary. However, the Agency has revised §704.11 to specify the retention only ofthose records mentioned in the first paragraph ofthis Unit.

E. Confidentiality

Section 14(a) ofTSCA allows a'person who submits information to EPA to assert a claim ofconfidentiality, if release of the information would reveal trade secrets or confidential commercial

or financial information. Under the CAIR, claims ofconfidentiality canbe asserted only at the time information is submitted and only in the manner specified in §704.219. Detailed instructions and a substantiation form for asserting and substantiating confidentiality claims underthis rule are contained in Appendix II of theCAIR Form. EPA's procedures for processing and reviewing confidentiality claims are set forth at 40 CFRpart 2,Subpart B.

Any submitter who claims information on a submission as confidential is required to provide two copies ofthe submission: a complete copy ofthe form, including all information claimed as confidential, and

a "sanitized" copy from which all confidential information has been

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### Federal Register / Vol. 53, No. 246 / Thursday, December 22. 1988 / Rules and Regulations 51705

deleted. EPA willplace the submitter's sanitized copy in thepublic file.

Therulerequires submitters to substantiate all confidentiality claims, by answering questions contained in Appendix 11 ofthe CAIR form. Rather than providing a separate substantiation for each reporting item claimed as confidential, submitters may organize the claimed information into categories, (e.g., production volume or submitter identity) and submit a single substantiation foreach category. In addition to answering questions pertaining to the individual categories, submitters are required to answer questions pertaining to all confidentiality claims asserted.

Asis detailed in the instructions in Appendix IIofthe CAIR Form, each question is claimed as confidential by identifying the appropriate category of confidentiality. Only those categories identified as confidential by submitters have to be substantiated. The substantiation questions outline the analytic process the submitters should go through before asserting a claim of confidentiality, helping the submitter to focus on relevant issues.

Commenters have stated that this requirement isburdensome, and thatthe effortrequired tocomplete reporting forms and the accompanying substantiation would be laborious. EPA recognizes the effortnecessary for reporting but does not find theburden

onerous and therefore has not altered therequirement. EPArequires up-front substantiation ofonly the six categories of confidentiality claims rather than separate substantiation foreach and every reporting item.This willminimize thereporting requirement while providing adequate substantiation.

Commenters questioned thevalidity ofrequiring up-front substantiation of confidentiality claims. Commenters stated that TSCA section 14(c)L) contains no authority for requiring upfront substantiation ofconfidentiality claims.Section 14(c)[) allows submittersto designate data as confidential and provides for separate submission ofsuch data.While section 14(c)(1) does not specify substantiation, it does provide fordesignation ofclaims in writing and "in such manner as the Administrator may prescribe," contemplating requirements involving

more thanjust an assertion ofa claim. EPA is committed to thepublic disclosure ofas much nonconfidential information collected underthe rule as possible. Requiring up-front substantiation ofconfidentiality claims and continued close scrutiny ofsuch claims through the established claim review process willensure that as much information as possible is releasable. Public interest in the information generated by this rulejustifies this approach. Up-front substantiation obviates the need forfollow-up substantiation by submitters resulting from EPA review orFreedom of Information Actrequests.

I Ifa company fails to submit a sanitized copy ofits submission,EPA will notify the company by registered mail. The respondent will have 30 days from the date ofreceipt of the notice letter to submit therequired second
copy. Ifthe Agency does not receive the requested sanitized version, EPAwill place the confidential copy ofthe submission in thepublic file on the 31st day after the submitter'e receipt of. EPA's letter.Ifno claim of confidentiality accompanies a document

or the claimis unaccompanied by the required substantiation at the time it is submitted to EPA, the company will be notified thatthe unsanitized copy will be placed in thepublic file.

EPA will attempt to provide the public with sufficient and informative access to information collectedunder this rule while protecting submitters' valid proprietary interests. This willbe accomplished by: (1) disclosing to the public all reported information not claimed as confidential; and (2) releasing nonconfidential aggregates of confidential information when possible.

The proposed rule specified that the sanitized copy of a confidential submission provide "generic" information foreach item claimed confidentiaL Commenters on the proposed rule expressed concern over the practicality ofa generic information requirement, pointing out the difficulty ofdevising generic descriptions of confidential data that would be meaningful to the public without revealing sensitive information. EPA
agrees that the difficulties ofsuch reporting are considerable and outweigh the limited usefulness ofgeneric information. EPAhas dropped this requirement.

Commenters also expressed concern

overthe potential forreleasing confidential business information (CBI) when sharing information obtained under CAIR within EPA and with other Federal agencies. EPA's security procedures under TSCA have adequately protected against release of confidential material during the Agency's 10-year administration of TSCA. All confidential data collected under the rule are subject to the requirements ofthe TSCA Confidential Business Information Security Manual and EPA's regulations at 40 CFR Part 2, Subpart B. EPA is also working with the participating agencies and will ensure that proper physical and procedural securityplans are inplace toprotect confidential information collectedunder therule. Also, before any transfer ofCBI material,EPA will clear any individual who needs access to TSCA CBI information.

The final requirements forclaiming CAIR data as CBI are summarized as follows:

1. Make assertions for claims of confidentiality atthe time information is submitted.

2. Signthe confidentiality certification
statement on the CAIRreporting form.

3. Provide EPAwith two copies ofthe submission (one complete confidential version and one "sanitized" nonconfidential version).

4.Mark the box on each question of the formwith the appropriate letter(s) representing thecategory ofinformation the claimis intended toprotect.

5.Provide complete, detailed answers to substantiation questions for each of the categories ofinformation claimed (see step 4 above), as well as to general questions thatmust be answered for all claims.

F. The CAZI Reportn Form
EPAhas compiled a comprehensive list ofquestions in the CAIR reporting form consistent with the information types listed In TSCA section 8(a)(2). Since many kinds ofinformation willbe neededto supportthe variety of chemical risk identification, assessment. and control action functions ofEPA and other Federal agencies,these questions
vary in the type ofinformation elements and comprehensiveness. For each listed substance, EPA willask only those

- questions that arepertinent to planned risk identification, assessment, or control actions for that substance. Persons subject tothe CAIR must

answer only those questions listed for the substance in thematrix in Subpart D ofthe rule.

The reporting form is divided into 10 sections, each section containing a list of specific questions. The form covers: plant site information; chemical identification; production, processing, and importation volumes; physical/ chemical properties; environmental fate data; economic and financial information; manufacturing and processing information; waste generation and management; worker exposure; and environmental release.

The reporting form alsoincludes detailed instructions including sample

answers. There are tables for converting numeric responses to metric units, and a glossary that defines key terms. Since

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### / Rules and Regulations

the proposal, the Agency has clarified

some definitions and added some others.

Section I ofthe formmust be completed by all respondents; the remaining parts are to be completed as specified in Subpart D ofthe rule. Questions in Section 1 ask forbasic information, forexample: plant site classification, respondent identification, and substance identification. Section 1 also contains questions forpersons who sell orbuy trade name products and a certification statement forpersons who had previously submitted information requested in Subpart D.

Companies that voluntarilysubmit information to EPA orother Federal agencies are encouraged to use the CAIR form.Ifthe substance they are reporting on is later added to the CAIR, these companies may be exempt from resubmitting the previously reported information. The companies would still be required to complete and submit Section I ofthe CAIR reporting form. However, the companies would be exempt from reporting any other data that werepreviously submitted, provided: that the previously submitted data are no more than 3years old as of the effective date ofthe substance's addition to the rule, the data are still complete and accurate, and a copy of theprevious submission is attached. Persons who use this exemption must sign the statement in Section I that certifies that the previously reported data meet therequirements set forth in the exemption.

At times, CAIR maybe used to require reporting on the same substance more than once. Some respondents may have little orno change to report in the second submission; these companies can
use the same exemption discussed above forvoluntary reporting. Such respondents need only complete Section 1ofthe reporting form, specify the date ofthe previous submission, and certify that thedata are still complete and accurate. This exemption will eliminate duplicative reporting and reduce the burden on companies subject to reporting more than once on a listed substance.

The Agency has revised the form based on public comments. In general, EPA has made the form easier to complete by eliminating complex and unnecessary questions, However, questions that arelikely to be asked in the future, though not requested in this iteration, remain on the form.The Agency has added clarifying language to the form to assist the respondent, and has also revised the instructions and glossary to add more sample answers and definitions. CAIR forms and instructions maybe obtained by telephoning the TSCA Assistance Office at (202) 554-1404, or by writing to the TSCA Assistance Office (TS-799), Office ofToxic Substances, Environmental ProtectionAgency, 401 M St., SW., Washington, DC 20460.

Some commenters were concerned that EPA will not have the staffto respond to the many questions the commenters anticipate will be asked during the reporting period. EPA assures the public that this willnot occur. Persons who have general questions concerning the rule orreporting form may call the TSCA Assistance Office at (202) 554-1404.TDD: (202) 554-0551. The Agency has also established a CAIR Office staffed by persons who can
answer technical questions on the requirements ofthe rule and the reporting form. When necessary, the TSCA Assistance Office will refer callers to the CAIR Office.Further, the questions ofgeneral interest asked duringthis time, and EPA's responses, will be summarized in a "Question and Answer" document. This document will be included with each CAIR form the Agency sends out starting with the second iteration ofthe CAIR.

IV. Substances listed in this Final Rule

Two program offices in EPA and three other Federal agencies nominated 47 substances for theproposed rule. After thoroughly reviewing the candidates,
two agencies have removed their requests, and EPA has reduced its own list ofchemical candidates. Therule

now contains 19 substances. The

reasons forwithdrawal ofsubstances, a summary of the concerns for the remaining substances, and how the requested information will be used follows. The substances are listed in Subpart D, §704.225, of theregulatory text.These are substances for which: (1) the agencies know or suspect cause adverse health or environmental effects yetlack current exposure data; (2) the agencies believe data gaps are significant; and (3) the agencies place a priority on the need for the requested information to complete assessments of the substances. The substances and the offices that nominated them are listed in Table I in thisUnit ofthe preamble. Additional background information on the substances is in the public record for thisrule.

Literature searches were undertaken for the information requested by the offices that nominated substances for thisrule. A listingofthe substances, along with the information requests, was sent forreview to each office in EPA and other Federal agencies participating in the CAIR's development. These offices searched their records for information on the substances; however, the searches did not provide the needed information.

The following offices and agencies nominated the substances included in thisfinal rule: EPA's Office ofAir and Radiation (OAR), EPA's Office ofToxic Substances (OTS), and the National Institute for Occupational Safety and Health (NIOSH). A total of23 nominations were made by these offices; however, since 4 ofthese nominations

were multiple nominations (i.e., substances nominated by two offices), 19 substances are listed in thisrule. Table I ofthisUnit ofthe preamble lists the 19 chemical substances.

The 19 substances listed in this rule include 7hazardous substances regulated under the Comprehensive Environmental Response, Compensation, and Liability Act of1980 (CERCLA). CERCLA requires persons who are in charge ofvessels or facilities,
to immediately notify the National Response Center ((800) 424-8802 or (202) 426-2675) when hazardous substances

are released in quantities that are equal
to orgreater than thereportable quantities (RQs). (See CERCLA section 103 and 40 CFR Part 302; 50 FR 13456, April4, 1985; 51 FR 34534, September 29, 1988.) CERCLA hazardous substances

are listed in Table 302.4-List of Hazardous Substances and Reportable Quantities (50FR 13475 and 51FR 34541).

The Agency received many comments

on the Federal government's justification forrequesting reporting for

some ofthe substances. Forthe final rule, the Agency has added additional background material on why the substances are listed in therule, and what the requesting offices intend to do with the CAIR reported data.

The Consumer Product Safety Commission (CPSC)nominated eight substances forthe proposed CAIR but dropped one substance (Urea,N-(4- chlorophenyl)-N'{(3,4-di-chlorophenyl}-. CAS No. 101-20-2) when it was determined that,although the substance

was on the TSCA Inventory, itpresently had no known TSCA uses and will subsequently be removed from the Inventory. CPSC dropped their remaining substances because of unexpectedly high costs to industry for compliance with CAIR, and because information gathered under the PAIR, the Federal Insecticide, Fungicide, and Rodenticide Act, and possibly, SARA, though not as detailed as CAIR information, will probably be sufficient for their needs.

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The Occupational Safety and Health Administration (OSHA)had requested information on seven chlorinated solvents listed in the proposed CAIR when it was preparing a Notice of Proposed Rulemaking for one ofthem, Methylene Chloride (DCM). Because of the length ofthe CAIR rulemaking
process and the current limitations on the scope ofthe evolving rule. OSHA proceededwith a survey ofDCM. This
survey included questions about the other chlorinated solvents frequently used as substitutes for DCM. Through its
survey, OSHA compiled the material needed forits analysis ofDCM. Thus, it has withdrawn its nomination ofthe

seven chlorinated solvents.

NIOSH has requested information on

one ofthe substances listed in the CAIR-4,4'-Methylenebis(-2- cbloroaniline) (MBOCA) (CAS No. 101- 14-4). MEOCA is aknown animal carcinogen. Potential for occupational
exposure exists because MBOCA is widely used as a curing agent in the production ofcast polyurethane articles. oTs has promulgated a chemicalspecific TSCA section 8(a) rule on MBOCA requiring notice to EPA ofthe initiation of any manufacture ofMBOCA in the U.S. However, that rule will not provide the information NIOSH needs concerning exposures from current uses ofimported MEOCA. All ofthe questions NIOSH requested pertain to identifying the number ofworkers exposed, degree of exposure, and extent ofmedical and environmental monitoring. This information is useful to NIOSH in identifying worker groups suitable for epidemiologic study andtor notification and screening programs. The extent ofMBOCA use is difficult to characterize because not all polyurethane manufacturing plants use MBOCA, and those that do, use it in a variable proportion oftheir products. Although efforts have been made by OSHA. NIOSI, and EPA to characterize the extent ofexposure to MBOCA, estimates ofnumbers ofworkers exposed have been very uncertain. The degree ofworker exposure at facilities that use MBOCA in the manufacture of polyurethane products is also difficult to estimate because there is no centralized data collection of environmental and medical monitoringresults.

NIOSH can use the data collected under CAIR to identify sites for several types ofoccupational health research studies, including industrial hygiene
surveys, surveys on the efficacy of monitoring techniques, epidemiologic studies, and identification ofsites for an Industry-wide exposure registry.The CAIR data will also be usedin formulating NIOSH recommendations for limitingoccupational exposure to MBOCA. Given the potential for continued worker exposure in the processing ofMBOCA, NIOSH believes that an ongoing and comprehensive
assessment ofworker exposure to MBOCA is warranted.

EPA's Office ofAir Quality Planning and Standards (OAQPS) of the Office of Air and Radiation has requested information on five ofthe substances listed in the CAIR. They are four Toluene Diisocyanates (TDI isomers): Benzene, 1,3-diisocyanato-2-methyl- (CAS No. 91-08-7), Benzene, 2,4- diisocyanato-1-methyl- (CAS No. 584- 84-9), Benzene, diisocyanatomethyl- (CAS No. 1321-38-6), Benzene, 1,3- diisocyanatomethyl- (CAS No. 26471- 62-5); and Chlorine (CAS No. 7782-50- 5). The TDIisomers as a group of compounds present potential health
treats and have large production volumes. All ofthe substances nominated are volatile and can be absorbed through the respiratory tract. Human effects that result from exposure to these substances can include potential carcinogenic, teratogenic, or mutagenic responses; extreme eye, lung, and mucous membrane irritation; or neurotoxic effects. The toxicity ofthese substances and their high level of production has raised conterns about the potential forhuman health effects from ambient air exposure. OAQPS needs detailed production and exposure information to determine whether these substances present anactual threat to human health.

Benzene, 1,3-diisocyanatomethyl- (CAS No. 26471-62-5) has been classified as a GroupB2 carcinogen basedupon the EPA Guidelines for Carcinogen Risk Assessment, September 24, 1988 (51 FR 33992). This classification indicates that there is sufficient evidence ofcarcinogenicity from animal studies. The potential health effects, other than cancer, associatedwith
exposure to.TDI isomers include respiratory effects (irritationf inflammation ofthe respiratory tract, pulmonary hypersensitivity, lung function decrements), dermal sensitization, and skin andeye irritation. The potential health effects associated with exposure to chlorine are eye and respiratory irritation atlower concentrations and pulmonary edema leading potentially to death at higher concentrations.

The data developed through reporting under the CAIR willbe used to develop the exposure and risk analyses for these substances, thereby supporting, decisions on the need toregulate these substances underthe Clean AirAct (CAA).

OAQPS has dropped two ofthe substances (ammonia and propylene oxide) it nominated in theproposed rule because CAA regulatory evaluations are

now essentially complete for these substances. In addition, OAQPS has dropped styrene because ofthe high
costs to industry associated with reporting on this substance and the high number ofburden hours which would be utilized.

OTS had requested information on 23 ofthe substances listed in theproposed CAIR. The substances had been nominated by two different divisions of OTS. Four ofthe substances were also
among the group nominated by OAQPS.

The 17 substances nominated by the Exposure Evaluation Division(ELD) have been dropped from this final rule. The substances fell under three categories: (1)fertilizers widely found in ground water, (2) volatile organic compounds found inground water,and (3) some chlorinated solvents.

The fertilizers have been eliminated from thisrule because these substances

are no longer ofhigh priority to EED. While EEDremains concerned about the exposure potential ofthese substances, the resources maynot be available to properly assess CAIR data ifitwere reported.

Data on the volatile organic compounds will probably be available followingSARA section 313 reporting. It islikely that this information will be sufficient to meet theneeds ofEED, thus negating the need forCAIR data.

The SARA section 313 rule will also provide data needed byEED in their
assessment ofthechlorinated solvents. Further,data submitted tothe Office of Air and Radiation under section 114 of the CAA has provided significant information onthe majorpoint sources ofthe chlorinated solvents. In addition, the chlorinated solvents project is expected to be completed before the data are expected under the CAIR. Finally, CAIR addresses manufacturers and processors, not theusers of substances who are ofmostinterest to the solvents project.

If,after the review ofthese alternative

sources. EED decides that additional CAIR data areneeded. EPAwill review and promulgate reporting requirements and questions, or a subset ofquestions, listed in theproposed rule.

TheExisting ChemicalAssessment Division (ECAD) ofOTShad nominated 18 ofthe oTs substances. ECAD has decided to withdraw one chemical substance, acid orange 7,because other higherpriority effortsprecluded further

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work on this substance at this time.The 17 remaining substances fall within 5 groups, the first group includes acetamide (CAS No.60-35-5) and Broenner's acid (CAS No. 93-00-5). Acetamide is a known animal carcinogen, and Broenner's acid may contain the impurity betanaphthylamine, a known human carcinogen. Preliminary assessments had been conducted forboth acetamide and Broenner's acid, buttoo little exposure-related information was available to proceed with an assessment.Human and environmental risk is largely unknown dueto the lack ofavailable exposure data. Itis for this

reason that EPA has requested such a broadrange ofinformation on these substances. Should subsequent assessments ofthese substances indicate potential risks, OTS will consider regulations to reduce identified risks where necessary.

The second group consists ofcertain substances found in human adipose tissue. These four substances are phenanthrene (CAS No. 85-4n-8); ethanol, 2-chloro-, phosphate (3:1) (CAS No. 115-96-8); pyrene (CAS No. 129-00- 0); and dimethyl disulfide (CAS No624- 92-0). These substances have come to the Agency's attention through the systematic screening ofchemicals identified in human tissue samples and other environmental media. The widespread exposure demonstrated by these data fromthe National Human Monitoring Program, coupled with known information on'the toxicity of these substances, warrants investigation ofthe possible sources of contamination. Manufacture, process, and useinformation needed to complete risk assessment of these substances is
not available through other sources; the CAIR data will enable the exposure assessment to proceed without further delay. The exposure assessment, in turn, is a component ofthe broader risk
assessment process conducted to determine ifrisk reduction alternatives need to be considered. These risk assessment and risk management. activities will resultin some type ofrisk reduction under TSCA, referral to another Agency program office or Federal agency, or a drop from further consideration because oflow exposure potential, orlow priority for other

reasons.

The third group consists offour substances: hydroxylamine (CAS No. .7803-49-8) and three ofits salts (CAS Nos. 5470-11-1,10039-54, and 10040- 00-1). The toxic properties of hydroxylamine are documented in OTS' Chemical Hazard Information Profile (CHIP) document (September 11, 1984). These include hematologic, genotoxic, and developmental effects. Exposure may occur during many possible uses of hydroxylamine and its salts. The best documented use is in color developer solutions, but the National Occupational Hazard Survey (NOHS) lists a wide variety ofindustries with potential hydroxylamine exposure. EPA has not been able to document actual use orthe extent ofuse ofhydroxylamines outside chemical processing, photo developing, and laboratory research. Furthermore, the Agencyhas little information on the amount ofhydroxylamines in these known uses. Concern is warranted since the possible uses ofhydroxylamines as antioxidants, for example, could cause widespread exposure.

The CAIR is intended to obtain information that verifies some ofthese suspected uses (or verifies that these

uses arenot widespread). The CAIR will alsoprovide some information on amounts and concentrations ofthe hydroxylamine compounds in various
uses, and exposure data. This information can be used to focus the Agency's efforts on hydroxylamine uses with highest exposures and determine whether these uses maypresent an unreasonable risk.

Preliminary risk evaluations were conducted by ECAD on the fourth group: semicarbazide (CAS No. 57-56-7), semicarbazide hydrochloride (CAS No. 563-41-7), and 1,1,2,2-tetrabromoethane [CAS No. 79-27-6). Semicarbazide and semicarbazide hydrochloride present carcinogenic, teratogenic, and acute health concerns. Onlylimited production, exposure, and use data are available for these two substances. Two manufacturers and oneimporter have been identified,but these substances are apparently produced for captive use by

a number of companies. In addition, little Information is available on the number ofprocessors, their employees, and extent ofemployee exposure. Three

useshave been reported, but other potential uses have been identified. These other uses may involve exposures ofa greater magnitude or by a different route than thoseuses known to exist. Tetrabromoethane alsoraises carcinogenic health concerns in addition to causing acute and chronic liver, kidney, and lung effects. Until recently, production was nearly 5 million pounds peryear, with nearly all used as a catalyst orcatalyst initiator inthe oxidation ofp-xylene to produce terephthalic acid. Production has reportedly decreased substantially during the last2 years, which mitigates the risk case. The information required in the CAIR will confirm this change in production needs and provide information on the use pattern.

Risk assessments are planned for the fifth and final group: the TDI isomers. These are the same substances nominated by OAQPS, and include two individual TDIisomers and two CAS numbers formixed TDI isomers. Exposure toTDI has been associated with carcinogenic, respiratory, immunologic, dermal, and neurologic effects as Well as isolated reports of hematologic and gastrointestinal symptomology. It is apparent that the observed effects are directly related to the exposure concentration, length of exposure, and the route ofexposure.

OTS in coordination with OAQPS, NIOSH, and CPSC, has substantial

concern forpersons exposed to TDI in several situations. First,persons residing in the vicinity ofTDI manufacturing, processing, and use facilities maybe exposed to fugitive TDI emissions. Accordingly, OAQPS is issuing CAA section 114 letters toTDI manufacturers to obtain emissions information. OTS and OAQPS intend to share these data. CAIR questions to TDI producers thatwill be addressed through CAA section 114 letters have been withdrawn. Emissions data from non-producers (importers and processors) will continue to be sought through CAIR.

Clearly theprojected regulatory endpoints, ifany, forTDI cannot be suggested until all the data are available and analyses have beenmade. The extremely broad spectrum of applications forTDI-containing materials mandate that EPA perform detailed risk/benefit analyses regarding the TDIisomers. These, ofcourse, require information that onlyindustry

can provide.

The second exposure ofconcern to OTS and NIOSH is occupational exposure toTDI through processing or
useofTDI-containing materials. OTS will be sharing these CAIR-generated data with NIOSH. As appropriate, the American Conference ofGovernmental Industrial Hygienists (ACGIH) and OSHA will be advised ofsignificant 

### findings.

Lastly;both CPCS and oTs share interests in consumers potentially exposed toTDI through home use of publicly available consumer goods containing this diisocyanate. These products include sealants, coatings, adhesives, foam insulation, and polyurethane finishes. Any information obtained will be shared with CPSC.

The chemical list which cites the offices that nominated the substances follows.

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### Federal Register / Vol. 53, No. 246 / Thursday, December 22,. 1988 / Rules and Regulations '51709

TABLE I-CHEMICAL LIST

Federal = 9 [ who must repoWt Coverage period O sselected

EPA/OTS/ECAD

....................
EPA/OTS/ECAD

....................
EPA/OTS/ECAD

.................... EPA/OTS/ECAD

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

EPA/OAR I

............................. EPA/OTS/ECAD

.................... M, X/P, I, P4

M, I

M, X/P, I,P M, X/P, I,P

M, I X/P, P M, X/P, I,P

EPA/OTS/ECAD

.................... IM,I

NIOSH

...................................
EPA/OTS/ECAD

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

EPA/OTS/ECAD

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

EPA/OTS/ECAD...................

EPA/OAR

...............................
EPA/OTS/ECAD

.................... X/P, P

M, I

M, I
M,X/P, I,P

M,I x/P, P M,X/P, I,P

EPA/OTS/ECAD

.................. M,I

EPA/OAR

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

EPA/OTS/ECAD

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

EPA/OTS/EAD

....................
EPA/OAR

.......................
EPA/OTS/ECAD

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

EPA/OTS/ECAD

....... ;

.......
EPA/OTS/ECAD

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

EPA/OAR

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

EPA/OTS/ECAD

.................... M,I X/P. P M,X/P, I,P

M,X/P, I,P

M

M,

X/P, I,P

M,X/P, I,P

M,X/P, I.P

M,I X/P, P M,X/P, I,P 2/8/87-2/5/89

.................
2/8/87-2/5/89

............. 2/8/87-2/5/89

.................. 2/8/87-2/5/89

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

2/8/87-2/5/89.

...... 2/8/87-2/5/89

. ...... 2/8/87-2/5/89

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

2/8/87-2/5/89

.......... .......
2/8/87-2/5/89

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................. Hydraz/necatboxaride (CAS No. 57-56-7) 1, 2.08, 2.12, 2.13, 9.02,

9.03, 9.08. Acetamide (CAS No. 60-35-5) 1, 2.01, 2.04 thru 2.06, 2.08, 2.12 thin

2.14, 2.17, 3.04, 9.04 th 9.07. Ethane 1, 1,2,2tefrabromo. (CAS No. 79-27-6) 1, 2.08, 2.12, 2.13. Phenanthrene (CAS No. 85-01-8) 1,2.01, 2'03, 2.05 thru 2.08, 2.11

thru 2.14, 2.16, 2.17, 9.02, 10.05, 10.06. Benzene, 1,3-dfisocyaneto-2-me0A.(CAS No. 91-08-7)

1,2.05 thru 2.07, 2.11, 4.01, 7.03 thru 7.08, 10.02, 10.08. 1, 2.04 thru 2.09, 2.11 thru 2.16, 3 all, 4.01 thru 4.05, 5 all, 6.05, 7.01,

7.05, 7.06, 8.01, 8.05, 8.08, 6.23, 9.01 thru 9.15, 9.19, 9.20, 9.22, 10.01, 10.02, 10.05, 10.09 thru 10.16, 10.23. 2-Naphthalenesulfonlc acid, 6-amino. (CAS No. 93-00-5) 1, 2.01,

2.04 thru 2.06, 2.08, 2.11, 2.12, 2.17, 3.04, 4.01, 9.07, 10.05, 10.06. Benzeneamine, 4,4'-methylenebis[2-chloro- (CAS No. 101-14-4) 1,

9.01, 9.03, 9.06, 9.08, 9.12, 9.15. Ethan, 2.choro., phosphate(3:1) (CAS No. 115-96-8) 1,2.01, 2.03,

2.05 thru 2.08, 2.11 thru 2.14, 2.16, 2.17, 9.02, 10.05, 10.06. Pyrene(CAS No. 129-00-0) 1, 2.01, 2.03, 2.05 thru 2.08, 2.11 hru

2.14, 2.16, 2.17, 9.02, 10.05, 10.08. Hydrazinecarboxamde, monohydrochlorlde (CAS No. 563-41-7) 1,

2.08, 2.12,2.13, 9.02, 9.03, 9.06. Benzene, 2,4-ocyanato-1-mthy. (CAS No. 584-84-9) I 1, 2.05 thru 2.07, 2.11, 4.01, 7.03 thru 7.08, 10.02, 10.08. 1, 2.04 tthu 2.09, 2.11 thru 2.16, 3 all, 4.01 thru 4.05, 5 all, 6.05, 7.01,

7.05, 7.08, 8.01, 8.05, 8.06, 8.23, 9.01 thru 9.15, 9.19, 9.20, 9.22, 10.01, 10.02, 10.05, 10.09 thru 10.16, 10.23. DIsulfide,dYmethyl (CAS No. 624-92-0) 1, 2.01, 2.03, 2.05 thru 2.08,

2.11 thru 2.14,2.16,2.17,9.02, 10.05, 10.08. Benzene, ditsocyanatomethyl-(CAS No. 1321-38-) 1 1, 2.05 thru 2.07, 2.11, 4.01, 7.03 thru 7.08, 10.02, 10.06, 10.08. 1, 2.04 thru 2.09, 2.11 thru2.16, 3 all, 4.01 thru 4.05, 5 all, 6.05, 7.01,

7.05, 7.06, 8.01, 8.05, 8.08, 8.23, 9.01 thru 9.15, 9.19, 9.20, 9.22,

- 10.01, 10.02, 10.05, 10.08, 10.08thrum10.16, 10.23. Hydroxy/amne, hy&ohde (CAS No. 5470-11-1) 1,2.07, 2.12 thru

2.14, 3.04, 6.03 thin 6.05, 9.01. Chlorne(CAS No. 7782-50-5) 1, 2.05 thru 2.07, 2.11, 4.01, 7.03 thru

.7.08, 10.02, 10.08. Hydroxylamne (CAS No. 7803-49-8) 1, 2.07, 2.12 thru 2.14, 3.04,

6.03 thin 6.05, 9.01. Hydroxy/amine, sulfate (2:1) (CAS No. 10039-54-0) 1, 2.07, 2.12 thru

2.14, 3.04, 6.03 thru 6.05, 9.01. Hydroxylamine, suffate (1:1) (CAS No. 10046-00-1) 1, 2.07, 2.12

thru 2.14, 3.04, 6.03 thru 6.05, 9.01. Benzene ,3.dlsocyanatomethy- (CAS No. 26471-62-5)

1, 2.08 thru 2.07, 2.11, 4.01, 7.03 thru 7.06, 10.02, 10.08, 10.08. 1, 2.04 thru 2.09, 2.11 thru 2.16, 3 all, 4.01 thru 4.05, 5 all, 6.05, 7.01,

7.05, 7.08, 8.01,'8.05, 8.08, 8.23, 9.01 thru 9.15, 9.19, 9.20, 9.22, 10.01, 10.02, 10.05, 10.08, 10.09 thru 10.16, 10.23.

'EPA/OAR = Environmental Protection Agency-.Office of Air and Radiation.

EPA/OTSECAD = Environmental Protection A of Toxic Substances-Eing Chemical Assessment Division. 'NIOSH = Naional Institute for Oc Sfety a Heath.

4 M = Each PersonWho Manufactured the Substance for Commerciel Purposes. I = Each Person Who Imported me Substance for Commercial Pu P = Each Person Who Processed the Substance for Commercial =-es X/P

- Each Person Who Manufactured, Imported, or Processed the Substance for Commercial Purposes and-Distributed the Substance under a Trade Name.

V. CAIR Information Management

EPA has developed a data base to store all of thereported CAIR information in a manner that allows EPA to determine easily whether the required data have already been collected under the CAMR, to produce reports in standard formats, and to protect proprietary information. The data base is an essential component of CAIR information management. Offices considering the development of information-gathering rules will be able to check the CAIR data base before requesting the information from

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industry. This procedure will help reduce duplicative requests, Further, reported data willbe available quickly and in an appropriate format for the user's review.

Commenters on the proposed rule expressed concern about EPA's ability to manage the quantity ofdata that the CAIR will generate. EPAplans to devote substantial resources for the implementation ofthe CAIR. While the CAIR will produce a significant amount of data, EPA has the necessary systems and personnel to process thevolume of data generated by the CAIR. EPAhas experience with processing large amounts ofdata from the TSCA section 8(a) PAIR, and JURreporting, and will be able toboth process CAIR data and make it available as needed.

VI. The CAIR andOther InformationGathering Mechanisms

The comprehensive nature ofthe CAIR and the reporting form allow EPA in many instances to gather information' for offices in EPA and otherFederal agencies. However, the CAIR is not being promulgated as a replacement for all other information-gathering regulations, norhas any other office delegated its information-gathering authority to theCAIR. The CAIR willbe used only when it is appropriate and is the most efficient means togather information. Other agencies or EPA offices will usetheir own authority under circumstances such as: (1) the substance ofinterest cannot be regulated under TSCA (e.g., the substance is not a "chemical substance"

or "mixture" as defined in section 3 of TSCA); (2) the information being sought could be gathered more efficiently using another authority; or (3)the information being sought ismore specific and detailed than would be elicited by the questions in the CAIR reporting form. Therefore, while other offices within EPA and other agencies will consider utilizing the CAIR for informationgathering, EPA does not expect the CAIR to be a replacement for all datagathering regulations.
VIi. Implementation ofthe Rule
A. TheNeed forInformation
Prior to listingthe 19 substances in this rule,EPA searched for the requested information to determine ifthe information was already available. Each office and agency involved in developing the CAIR searched for this information in their data bases and the public literature; they were, however, unable to locate therequested Information listed in Subpart D ofthis rule. EPA has established a formal process whereby each office oragency that wants to add a substance to the CA1R must submit detailed nomination material to oS (the nomination material for the substances in this final rule consist ofmemoranda tothepublic record with relevant support documents). The nomination must include: why the informationis needed, howthe nominating office will use the reported data, and any other pertinent information the Agency deems necessary. OTSwill then determine whether the substance is a potential candidate forthe CAIR.

Substances that pass OTS' initial screening will be submitted to an inter. agency, government-wide workgroup for review.As was donefor the substances in thisfinal rule, the workgroup (made up ofrepresentatives from program offices in EPA and otherFederal agencies) reviews the list ofsubstances and information requests. Ifneeded informationis available, the requesting office is notified and the substance withdrawn from the list ofpotential candidates for addition to the CAIR. Comments provided by the public on the chemical substance nominated in a proposed rule may also lead to the withdrawal ofthe substance or revised information requests.
-B. Budgeting forBurden
EPA has prepared an information collectionrequest that estimates the reporting burden that the CAIR would impose. The Paperwork Reduction Act requires EPA to collect information from thepublic in the least burdensome way and to summarize, for theOffice of Management and Budget's (OMB) review, information collection activities and their associated burden. Aspart of thisprocess, an Information Collection Budget (ICB)is developed that estimates the total numberofburden hours the Agency will impose on thepublic during the next fiscal year.

CAIR is included in this budget process.In June ofeach year, each program office participating in CAIR will submit an ICB profile to the Information and Regulatory Systems Division (IRSD) inEPA's Office of Policy,Planning andEvaluation. This profile will contain the estimated number ofsubstances on which the program expects to request data, the total burden hours associated with the request, and, ifpossible,the names of the substances involved. Based onthis profile, each program office will have a CAIR line item on the ICB containing that office's total burden hours for CAIR requests.Making each EPA office accountable forthe burden they impose through the CAIR will ensure that they

use the rulejudiciously.

For the substances listed in thisfinal rule, the 01'Shas budgeted for the" burden hours forits substances along with the substances added by NIOSH. (OAR has accounted for its own substances.) in the future, each EPA office that adds a substance to the CAIN will account forthe burden hours as described above while other agencies that add substances to CAIR will
account for theburden hours in their

own ICB.

Some commenters suggested that the CAIR will dramatically increase the government-wide reporting burden placed on industry each year and, in an effort to reduce this effect, EPAshould not continue with the CAIR. EPA does
not agree with these commenters' conclusionsregarding theincreased reporting burden.First,ifEPA did not continue with the CAIR, the burden hours allocated for therule would be available elsewhere in theAgency for

use.Thus, there would be no net difference in theburden placed on industry by EPA Ifthe CAIR is or is not promulgated. Second, theAgency has developed CAIR as an efficient information-gathering tool that should require less burden to comply with over timethan separate rules gathering the

same information. That is,more information can be collected at the same

orless costusing theCAIR than using individual information-gathering rules.

C.Assistance forSubmitters
Giv6n the comprehensive nature of

some questions in the CAIR reporting form, EPA is committed to providing technical assistance to companies reporting forthe CAIR. Besides the instruction document that accompanies thereporting form, companies will be able to contact EPA or its contractor for assistance. An assistance office has been established to answer questions regarding the CAIR and willbe staffed by a team ofinformation specialists who

are thoroughly familiar with the rule requirements andreporting form.

For the second iteration ofCAIR, the Agency will compile and distribute a summary of "Questions and Answers" asked by submitters. The Agency has also developed a brochure that explains how the CAIR operates. Copies of this brochure are available from the TSCA Assistance Office.

D. Evaluation

To ensure that the CAIR meets its objectives ofproviding timely, reliable, useful, and non-duplicative data while Imposing aminimum burden on

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industry, EPAhas and will continue to evaluate the CAIR. The Agency has conducted a review ofthe final rule package to assure that there is adequate documentation tojustify each information request.

The Agency has also reviewed the effectiveness ofthe nominating process in meeting the requirements of the Paperwork Reduction Act. Since the nomination process is standard forOTS, this review involved all OTS ICRS, including the CAIR. It is also the Agency's intention to evaluate the data submitted under theCAIR byreviewing forms for apparent inconsistencies and surveying submitters to determine problem areas.

Finally, a survey ofdata users both withinEPA and at other agencies that nominated listed substances willbe conducted. Interviews with a sample of

users willbe conducted to assure that the data submitted meet the needs ofthe

user.A special report will be prepared that will examine any problem with timeliness ofdata receipt and determine ifthe levels ofprecision and specificity havebeen met.
VIII. Public Participation

EPAbelieves that thepublic review that occurred duringthe development of this rule was important. TheAgency actively sought publicinput early in the developmental stages of therule and metwith all organizations requesting a meeting.Two general public meetings

were held in July of1985 to discuss an early draft ofthe rule and reporting form. Constructive comments helped EPA refine the rule to make it more understandable and effective. After further revisions, the CAIR reporting form was circulated again for public review in December 1985. Again, more constructive comments were made,and many were adopted.

EPA issued a notice on January 24, 1986 (51 FR 3251), asking for participation in a pretest ofthe reporting form. The purpose ofthe pretest was two-fold: (1)to test whether the questions are easilyunderstood, and (2) to estimate thereporting burden associated with answering questions. The Agency had hopedmany volunteers would participate. However, fewer applied than were expected. Therefore, the Agency does not viewthe results of this pretest as representative ofthe entire industry. The pretest did, however, provide extremely valuable "hands-on" data that were used in making changes to the form and for determining the economic impact of this rule.

After publication ofthe proposed rule (51 FR 35762), EPA extended thepublic comment period. The Agency appreciates all ofthe comments that have been made, and this final rule, reflects EPAs consideration ofthose comments.
IX. Alternatives Considered

Before and during the development of the CAIR, the Agency considered three major alternative approaches for meeting its information-gathering objectives: (1)issuing chemical-specific TSCA section 8(a) rules, (2) issuing the CAIR list ofquestions as guidelines for incorporation in chemical-specific rules, and (3) developing a three-tier approach to reporting (ofwhichparts of CAIR would comprise the firsttwo tiers). After review ofthese approaches, the Agency decided to develop the CAIR as proposed.

Chemical-specific rules, unlike the CAIR, canbe tailored to meet very specific needs. However, as discussed above,these rules are costly for EPAto establish and implement, and for industry to respond to.Ifspecific information is needed that is beyond the scope ofCAIR, theAgency always has the option ofissuing a chemical-specific rule for that substance.

A variation ofthe chemical-specific option would be the issuance of the CAIR list ofquestions as guidelines. Whenever an information need arose, questions from the guidelines could be chosen and incorporated into a chemical-specific rule. An advantage of this option is that the guidelines could be modified as necessary without notice and comment.

TheAgency has determined that such

an option would be less desirable than issuance ofa model-rule because many of the efficiencies offered by a model rule would be diminished orlost. There would be a diminished incentive to use the questions exactly as they are written.The additional variability industry would face with such minor changes would impose substantial costs to industry in responding to each chemical-specific rule. Also, chemicalspecific rules would require substantial additional space in the Federal Register since the questions would have to be stated in full rather than simply specified by number underthe CAIR.

Furthermore, there is no need to issue CAIR questions as guidelines. Many of the questions were taken from existing government forms previously used to collect information from industry. There has alsobeen much cooperation with industry representatives in developing theform so that thequestions willboth provide the information needed to EPA and be in the terminology used by industry.EPA does not anticipate that a major refinement ofthe questions will be necessary after promulgation ofthis final rule. Moreover, should the need arise, EPA can develop a TSCA section 8(a) chemical-specific rule with questions tailored to the unique characteristics ofthe requesters.

The last optionthat many commenters suggested was that EPA consider gathering information according to the stage ofassessment ofa substance. That is, for substances in the early stages of assessment, request onlybasic information like that found in the PAIR. If,following analysis ofthereported data,the Agency finds that additional information is needed, a more detailed substance-specific rule would be used.

EPAdoes not believe a tiered reporting approach is necessary or appropriate; in fact, such a reporting scheme could be counterproductive since it could involve two or three separate complete rulemakings that would be costly to EPA in terms of Agency resources and delays in obtaining the needed information. Whereas a tiered reporting approach might be feasible ifthe CAIR was solely

an OTS rule, the applicability ofthe CAIR to other program offices within EPA other than OTS, as well as to other Federal agencies, makes a tiered reporting approach impractical. The broad range oftopics covered by the CAIR is one ofthe primary benefits derived fromthe rule. An office or agency can choose specific questions on the CAIR according to its particular stage ofassessment.

X. Economic Analysis

A. Methodology

EPAhas conducted in-depth studies to estimate the amount of secretarial, technical, and managerial time needed
to respond to each question in the reporting form. These studies are located in the publicrecord forthis rulemaking.

The response times were derived from three major sources. One source was the set ofFederal personnel experienced in preparing questionnaires that contained questions similar to those in the reporting form. Another source was Federal agency documents that described and analyzed questionnaires that contained questions similar to those in thereporting form. The last source
waspersons in private industry and industry research organizations who performed surveys with questionnaires similar to the CAIR form. These persons provided estimates ofthe time required to respond to certain parts ofthe reporting form. The Agency also used a Federal Register / Vol. 53,

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pretest ofthe CAIR form to determine the time required to complete various questions on the reporting form.

The question-specific reporting burden was estimated for each of three distinctlabor categories: managerial, technical, and secretarial. Mean reporting times and variances were then calculated for each labor category. Applicable wage rates were then multiplied by the time estimates and the results were summed to establish the estimated reporting costper question. Combining the cost per question for all the questions required ofeach type of respondent yielded both a mean reporting cost and a 90-percent confidence level cost range.This procedure was followed for each chemical substance listed in Subpart D. The mean reporting costs (i.e.. unit costs) were further multiplied by the estimated numberofrespondents for each substance to determine the direct reporting cost oftherule.

EPA used the 1987update ofthe TSCA Inventory data base as its primary source ofplant sites that manufacture and/or import CAIR-listed substances. This provided the latest site
counts forall CAIR substances except chlorine. (Chlorine, an inorganic chemical, was not included in the Inventory update.) Additional data

sources were consulted to establish site count estimates forchlorine and to double-check estimates for the remaining CAIR substances. The Agency reviewed the following sources, among others: ChemicalEconomics Handbook, DirectoryofChemical Producers, Importersof Benzenoid Chemicalsand Products,Synthetic OrganicChemicals,ChemicalProducts Synopsis, MillionDollar Directory MarketIdentifiers,and the Census Bureau's Censusof Manufacturers. Articles fromrecent trade magazines andjournals, as well as contacts with a variety ofindustry personnel, were also used to identify plant sites.

To identify theplants that process the substances, data were collected on the downstream uses ofeach listed substance for which processor reporting is required. All those facilities that were strictly end users oflisted substances

were not considered tobe processors for this rule.

The final step associated with developing the site estimates was to determine the number of "unique sites"; that is,those sitesthat must report. Since a site with multipleprocesses may be required to report for more than one substance, it is most important notto count that site more than once. Adjustments ofsiteestimates were based on an examination ofthe specific identities and chemical operations of expected submitters.

Once site estimates were established, estimating a per substance cost for each respondent type was then a simple
matter.The estimated number ofsites
perrespondent category was multiplied by the appropriate estimated reporting
cost per substance. In turn, thereporting costs per substance were summed to provide the total direct reporting cost of the rule.

Reporting sites alsoincur a variety of indirect reporting costs.These involve such activities as familiarization with therule and its reporting requirements, the establishment and maintenance ofa recordkeeping system, notifyingEPA and/or customers of any tradenames, the cost ofsubstantiating any information claimed to be confidential, and the miscellaneous costs associated with reviewing, copying, and mailing the completed CAIR reporting form. In each
case, research wasconducted to determine the appropriate unit cost (per report or per site) ofeach indirect cost category. (Two sets ofunit costs were established in this analysis, one for a respondent answering a large number of questions and the other for a respondent answering a smallnumber of questions.) After unit costs were multiplied by the appropriate numberof sites and reports, theresults were summed toproduce the total indirect reporting cost ofthe rule.

The final step in determining the total cost ofthe rule wasto estimate the cost incurred by firms that must assess whether they are required to report. Two steps were required to calculate this compliance determination cost. The first step was to identify the number of sites that areexempt from reporting requirements. The second stepwas to estimate the cost ofmaking a compliance determination.

Those sites that do not manufacture, import, orprocess a listed substance are obviously not covered by theCAIR. The

sameis true ofthose sitesthat only use
a CAIR substance. While keeping these points in mind, the listof CAIR substances wasreviewed to determine the setofStandard Industrial Classification (SIC) codes likely to contain the sites subject to CAIR reporting or be exempt from reporting. The establishment counts in SIC 28, 29, 516, 2295,2515, 3069, 3086, and 5198 were tallied, and the sum was then reduced by the number ofsites listed as small businesses having annual sales under $4 million. (These sites are also exempt from CAIR reporting requirements.) The adjusted sum was further reduced by the estimated number ofsites that would report in the initial reporting period. A totalof14,855 exempt sites

was ultimately established.

The second step was to estimate the unit cost ofcompliance determination. A variety ofindustry and Agency sources
were consulted to establish a range of time (required by labor category) needed to determine that reporting is notrequired.The time estimates were thenmultiplied by appropriate labor
rates to provide a range ofcompliance determination costs. A unit cost of$33
per site was selected from the range after it was determined to be most applicable. (Itwasnecessary to allocate to the form familiarization cost category the compliance determination cost incurred by a site that mustreport under the CAIR. Since thereview ofreporting requirements that makes up a compliance determination is also a necessary part ofform familiarization. this allocation was done to prevent double counting ofcosts.) Theexempt ,site count was thenmultiplied by the unit cost ofcompliance determination to provide the final cost component ofthe CAIR.

Performing the set ofcalculations described above yields an estimated total cost for the 19 currently listed substances of$2.3 million. These costs

are broken down into direct reporting costs, indirect reporting costs, and compliance determination costs. The total direct reporting costis estimated to be $1.23 million.The total indirect reporting cost is estimated to be $560,788. The total compliance determination costis estimated to be $490,215 forthe 14,855 sites exempted from reporting requirements.

Based on theinformation collection requirements in this rule and the set of CAIR listed substances, theAgency calculated the expected costs ofa typical responding site that would incur all possible costs. (Not all sites will incur such costs as CBI substantiation and trade name notification, Moreover, these expected costs are averages and may not actuallymatch the cost ofa specific site.Thus, the costs presented below will be somewhat different from those derived by dividing total line item costs by the numberofresponding sites

or supplied reports.)

perreport.

150hours to gather and report the requested information

......................... $5,092
17houra to substantiate CBI claims

........... $ 8hoursto conduct trade name notification

.... .............. $360 11 hours to establish and file the records that support a reporting .effort

.............. $38 1.5 hours to incur miscellaneous costs (mailing, etc.)

.............................................. $70

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### Rules and Regulations 51713

persite:
43 hoursforrule and form familiarization

..................... $1,490
EPA assumes thai theper site costs will be incurred one-time only for those respondents that submit two ormore reports per site in any givenreporting year. Only theper report costs will be incurred for each report submitted by a responding site. EPA further assumes that sites which must report in a following year will incuronly a portion ofthe initial reporting year's per site
costs.This Is dueto the expected increase inrule familiarization and understanding as thereports are prepared over a period of time.This may in fact notbe entirely true in those cases in which a respondent must answer a small number ofquestions and, as a result, may not learn the entire reporting form.


### 8.EPA AdministrativeCosts

EPA will incur a variety ofcosts to process and maintain the information provided under the CAIR. This section briefly describes the costs associated with the Agency's administration ofthis rule.

EPA has developed a system to process and maintain the CAIR information. The major tasks in this overall effort areperforming a feasibility study, and developing a data entry system, data base system, andtracking system. The initial system design and development costs are estimated tobe $445,000. There will be an additional
cost of$65,00Y for the development of standardized reports forCAIR data

users.

EPA also expects to incur costsassociated with entering and processing data for the initial 19 chemicals, administrating the CAIR information office, and several otherprojects. These activities are estimated to cost $444,000.

In addition to the costs shown above, EPA willincur staffcosts for these rulerelated activities. Approximately 5.4 full-timeequivalents (FTEs)will be required in theimplementation ofthe initial CAIR. At$32,000 per FrE, the total of5.4 FTEs will costEPA $172,800.

Thus, it is assumed that EPA's expenditures for the development and implementation ofthis final rule willbe roughly $954,750 plus a total of$172,800 in staff costs.This yields a total cost to EPA of$1,127,550.

C.Responseto CommentsonEconomic Analysis

A variety of comments were received

on the proposed CAIR. Among these
comments were a set that specifically addressed cost estimates. In general, these comments all argued thatEPA's
cost estimate was considerably below the costindustry officials believed would be incurred.Listed below are the majorcomments addressing economic issues and the EPA response. More detailed responses can be found in the rulemaking record.

Anumber ofcommenters statedthat the unit labor rates EPA used were far below the levels found in industry today. It was argued that hourly wages
were too low and that labor overhead should also be included in cost estimates. Itwas also argued that the

use of only three labor categories (managerial, technical, and clerical) tended to bias downward the' cumulative cost of the work performed by all the different types ofpersonnel involved infilling out the CAIR reporting form. TheAgency agrees with these general
comments and has taken two major steps to address the concerns. First,EPA factored inflation levels since March 1984 into the set ofwage rates used to cost out the proposed CAIR. The unit labor costs were based on March 1984 data and,therefore, needed to be updated. Second, the Agency realized that industry responses to government health and environmental reporting requirements tend to be prepared by senior level personnel from a variety of backgrounds (financial, legal, and operational). Thus, the Agency used different and more senior labor cost categories from Bureau ofLabor Statistics data in establishing thenew unit labor rates for the economic analysis. These two major adjustments resulted in hourly wage rate increases of 27.3, 35.3, and 11.2 percent for managerial, technical, and clerical personnel, respectively.

The Agency does not agree that labor overhead should be factored into the cost estimates. The allocation ofany overhead expenses to CAIR reporting activities is an arbitrary exercise. This is especially true because the indirect reporting costs thatmight be classified

as overhead are addressed as separate line itemsin the cost estimates prepared forthe final rule. As an illustration, the indirectreporting costs associated with the establishment of a support document recordkeeping system arenow shown as

a distinct line item in the economic analysis.

Other commenters argued that EPA underestimated the total number of chemical processors that might be subject to reporting requirements, and thereby further underestimated the possible total cost ofthe rule. As an illustration, it was argued that the count used by EPA forthe number ofammonia processors and solvent processors was too low. Commenters also argued that EPA's site counts fornon-sample substances were low in some cases.

The Agency agrees with these
comments ingeneral. The Agency chose

a group ofsample substances to be representative, in terms of manufacturing operations, ofthe set of substances currently listed on the CAIR. The Agency conducted a comparison of the sample and non-sample substances and determined that the samples are representative of the total set in terms of chemical type, annual production volume, and the number of manufacturing sites.

The analysis prepared for the proposed CAIR estimated a total of roughly 298,000 processing sites forthe 15 sample substances. Follow-up work using additional primary and secondary data sources resulted in an increase in the count ofprocessing sites to roughly 308,700 sites.With respect to the site counts forthe non-sample substances, these estimates were derived from the data collected on the sample substances. Thus, they were only to be representative, not specific. The adjustments made to the site counts for the sample substances should result in

more accurate site counts fornonsample substances.

Some commenters believed that EPA underestimated the time and effort required to complete theCAIR reporting form. They argued that far more time would be required to collect data from scattered squrces, to coordinate form analysis and response efforts between different personnel, and to actually develop responses to various questions

on the form. With respect to this last issue, commenters argued that EPA failed to account for the additional reporting burden incurred byfirms that do multiple processing ofCAiR substances, have multiple work areas, or have multiple emission points. It was also argued that these firms would ostensibly be required to provide multiple responses to various questions

on the reporting form.

The Agency agrees with these points. As a result, additional cost line items

were added to account for the activities that had not been considered in the proposed rule's economic analysis. The

new cost line items are compliance determination, review and mailingof the final reporting form, collection and calculation ofdata required by CAIR form questions, and several other miscellaneous costs associated with form preparation. In addition, revisions

were made to the estimated costs for CBI substantiation, form familiarization,

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recordkeeping, and trade name notification. The result ofthese changes, plus the revised site counts and unit labor rates mentioned above, was an increase in the estimated total cost from $3.27 million to roughly $23.9 million. However, this cost was then reduced significantly by factoring inthe exemptions used in the final rule and by the change in the number ofsubstances

on the rule from 47for theproposed rule to 19 forthis final rule.

XI. Rulemaking Record

The following documents constitute the major documents in therecord for this rule (docket control number OPTS82013C). All documents, including the index to the complete record, 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-G004, 401 M Street, SW., Washington, DC 20460. The record includes butis not limited to the following information:

1.Federal Register Notices: (April4, 1985; 50FR 13391), (June 17,1985; 50FR 25095), (January 24,1986; 51 FR 3251), (February 28,1986; 51 FR 7120), and (December 19, 1986; 51 FR 45486).

2. Transcript ofpublic meeting held on July 17,1985.

3. Transcript ofpublic meeting held on July30, 1985.

4. Minutes ofmeetings held with the Chemical Manufacturers Association, the Synthetic Organic Chemical Manufacturers Association, and the American Petroleum Institute.

5.Copy ofmemorandum and CAIR reporting form circulated to the public forreview on December 9,1985. 6. CAIR reporting form response times and labor costs analysis, Centaur Associates, April 21, 1986.

7.Economic analysis ofthe CAIR. 8. Comments received on earlier drafts ofthe CAIR preamble and reporting form.

9. Background information on substances appearing in the proposed and final rule.

10. Proposed Rule October 7,1988; 51
FR 35762.

11. "Comments received on the proposed rule.

12. CAIR Pretest Summary Report, Science Applications International Corporation, March 20, 1987.

13. Correspondence with and from the publicregarding CAIR.

14. Minutes ofmeeting held with Industry,environmental, and labor organizations on February 26,1986.

15. Minutes ofmeeting with representatives fromthe Chemical Manufacturers Association, the Office of Management and Budget, and the Environmental Protection Agency held

on August 6, 1987.

16. Response to Comment document. 17. Final CAIR Reporting Form and Instructions.

XII. REGULATORY ASSESSMENT REQUIREMENTS
A. Executive Order12291

Under Executive Order 12291, EPA mustjudge whether a rule is "major" and therefore requires a Regulatory Impact Analysis. The Agency has, determined that this final rule is not "major" because it does nothave an effect of$100million ormore on the economy. EPA also anticipates that this rule will nothave a significant effect on competition, costs, orprices. This rule

was submitted to the OMB for review as required by Executive Order 12291. B. RegulatoryFlexibility Act

Under the Regulatory Flexibility Act, 5 U.S.C. 605(b), EPA certifies that this rule will nothave a significant impact on a substantial number ofsmall businesses. Smallbusinesses are defined inthis rule and are exempt fromreporting except under certain circumstances defined in TSCA.

C.Paperwork Reduction Act

The information collection requirements in this rule were submitted forapproval to the Office of Management and Budget (OMB)under the Paperwork Reduction Act of1980, 44 U.S.C. 3501 et seq.andhave been assigned OMB control number 2010- 0019.

Public reporting burden for this collection ofinformation is estimated to vary as presented in the following chart. These estimates include time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection ofinformation. To locate a respondent's burden estimate on the chart, identify the substance's CAS number and the respondent category for which the report is being submitted, and locate the corresponding range. Send comments regarding theburden estimate or any other aspect ofthis collection of information, including suggestions for reducing this burden,to Chief, Information Policy Branch,PM-223, U.S. Environmental Protection Agency,401 M Street, SW., Washington, DC 20460; and
to the Office ofInformation and Regulatory Affairs, Office of Management and Budget, Washington, DC 20503, marked "Attention: Desk Officer forEPA."

CAIR REPORTING BURDEN FOR BOTH QUESTION-SPECIFIC AND GENERAL COSTS (RANGE IN HOURS)

Oiem~~caI 

# I II M nacturer I Importer/ Chemical name CAS No. Manufacter Importer P roces re/ m 

## 4

. processor processor

orazneCaa.Xamloe

........................................ Ethane, 1,1,2.2-tetrabromo-

...................................... 57-6-7... 60-35-6

......... 7274-6.
Pr"Urnaww rw
............. ................ . ........................ 85-0!-8

......... Benzene, 1,3.disocyanato-2-methy

.................. ...... . 91-08-7

......... 2-Naphthalenesulfonic acid, 6-amino

.......... 93-00-5. Benzeneamine, 4,4-methyee l

................. 101-14-4..... Ethanol, 2.chloro-, phosphate (3:1)

......... ................. ....... 118-9-8

....... Pyrene

................... ..... ......... .... . 129-00-0..... Hydrazinecarboxamide, r.onohydrochod.d.... 563-41-7. Benzene, Z4-disocyanato-1-methyl-

..................... Disutfide, lirnethyl

.................... ..... .................... .. ............. ..... . 24-92..0.-.... dilsocyanatomethyl

.... .. ............................ ................. Hyoroxytamine, hydochlore

..................... Clodrine... .a.. ....... ,. ......... ................... Hydroxylamlne, sulfate (2:1).. Hydr0xytamlne, sulfate(1:1). 1321-38-6

..... 5470-11-1. 7782-50-5. 7803-49-8..... 10039-54-0... 10046-00-1- 39-47 45-57 37-41 40-47 194-231

44-54

NA 40-47 40-47 39-47 194-231

40-47 19-233

37-42 5-79 37-42 37-42 37-42 39-47 45-57 37-41' 40-46 98-114 44-54

NA 40-46 40-46 39-47 98-114 40-46 100-116

38-43

NA 38-43 38-43 38-43 '41-49 NA 37-41 40-48 268-316 NA 47-60

NA NA 41-49 268-316 NA 270-320

38-43

NA 38-43 38-43 38-43 44-56 61-79 37-42 44-54 403-466

55-72 55-72 44-54 44-54 44-56 403-466

44-54 407-471

39-44 91-128 39-44 39-44 39-44 Benzene, 41-50 51-65 37-41 41-49 266-315

48-61 47-60 41-49 41-49 41-50 268-315

41-49 269-318

38-43

NA 38-43 38-43 38-43 °°,o

. o.. .......- .. o. °

. , ............. ,....

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## I-Vol. 53, No. 246 / Thursday,..December 22, 1988 /Rules and Regulations

CAIR REPORTING BURDEN FOR BMT QUESTION-SPECIFIC AND GENERAL COSM (RANGE INJ-(OIRS)-Conflnued

Chemical name

Benzene, 1,1.-disocyanatomethyl-.

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

Listof Subjects in40CFR Part 704

Chemicals, Environmental protection, Hazardous materials, Reporting and recordkeeping requirements.

Dated: October 27,1988.
Lee M. Thomas, Administrator.

Therefore, 40 CFR Part.704 is amended as follows:

1. The authority citation forPart 704 continues to read as follows:

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

PART 704-REPORTING AND RECORDKEEPING REQUIREMENTS

2.By revising the Part heading toread

as setforth above.
Subpart A-General Reporting and Recordkeeping Provisionsfor Section 8(a) Information-Gathering Rules

3.By revising the Subpart A heading
to read as set forth above.

4. By revising 

### I § 704.1, 704,3, and 704.5 to read as follows:
§704.1 Scope.

(a)This Part specifies reporting and recordkeeping procedures under section 8(a) ofthe Toxic Substances Control Act (TSCA) formanufacturers, importers, andprocessors ofchemical substances and mixtures (hereafter collectively referred to as substances) that are identified in Subpart B orD ofthis Part. Thereporting and recordkeeping provisions in Subpart A ofthis Part apply throughout thisPart unless revised in anyother subpart.

(b)Subpart B ofthis Part sets out chemical-specific reporting and recordkeeping requirements under section 8(a) ofTSCA.

(c] Subpart C ofthis Part sets out the general reporting provisions forthe Comprehensive Assessment Information Rule (CAIR). CAIR standardizes certain section 8(a) rules by:providing a set of uniform questions for EPA and other agencies to usein assembling specific reporting requirements; requiring the submission of information on a standard reporting form; and establishing uniform reporting and recordkeeping provisions that supplement thereporting and recordkeeping provisions in Subpart A ofthis Part. CAIR provisions apply only to those persons who manufacture, CAS No. Manufacturer

.2"471-62-6.. 196-233

import, orprocess a substanceidentified in Subpart D of this Part during the time period forwhichreporting Is required.

(d)Subpart D of thisPart contains a matrix that identifies the substances for which EPA requires reporting under Subpart C. thepersons who mustreport the information to EPA, theinformation that must be reported, the coverage period (asthatterm is defined in § 704.203), and the effective date ofthe final rule.
§704.3 Definitions.

All definitions as set forth in section 3 ofTSCA apply inthis Part.In addition, the following definitions are provided forthe purposes ofthis Part.

"Annual" means the corporate fiscal year.

"Article" means a manufactured item (1)which is formed to a specific shape

or design duringmanufacture, (2) which has end use function(s) dependent in whole or inpart upon its shape or design during end use, and (3) which has either"

no change ofchemical composition duringits end use or only those changes ofcomposition which have no commercial purpose separate from that ofthe article, and that result from a chemical reaction that occurs upon end

use ofother chemical substances, mixtures, or articles; except that fluids and particles are not considered articles regardless ofshape ordesign.

"Byproduct" means a chemical substance produced without a separate commercial intent during the manufacture, processing, use, or disposal ofanother chemical substance(s) ormixture(s).

"CASNumber" means Chemical Abstracts Service Registry Number.

"Coproduct" means a chemical substance produced for a commercial purpose during the manufacture, processing, use, or disposal ofanother chemical substance ormixture.

"Customer" means any person to whom a manufacturer, importer, or processor directly distributes any quantity ofa chemical substance. mixture, mixture containing the substance or mixture, or article containing the substance ormixture, whether or not a sale is involved.

"Domestic" means within the geographical boundaries ofthe'50 United States,including the District of

- Columbia. the Commonwealth .ofPuerto Importer Processor

100-116 270-32

Rico,the Virgin Islands, Guam, American Samoa, the Northern-Mariana Islands, and any other territory or possession ofthe United States.

"Enclosed process" means a manufacturing or processing operation that is designed and operated so that there is no intentional release into the environment ofany substance present in the operation. An operation with fugitive, inadvertent, oremergency pressure reliefreleases remains an enclosed process so long as measures
are taken to prevent worker exposure to and environmental contamination from the releases,

"EPA"means the United States Environmental Protection Agency.

"Import" means to import for commercial purposes.

"Import for commercial purposes"

means to import with the purpose of obtaining an immediate or eventual commercial advantage forthe importer, and includes the importation ofany amount ofa chemical substance or mixture. If a chemical substance or mixture containing impurities is imported forcommercial purposes, then those impurities also are imported for commercial purposes.

"Import in bulk form" means to import

a chemical substance (other than as part ofa mixture orarticle) in any quantity, in cans, bottles, drums, barrels, packages, tanks, bags, or other containers, ifthe chemical substance is intended toberemoved from the container and the substance has an end

use or commercial purpose separate from the container. "Importer" means (1) anyperson who imports any chemical substance orany chemical substance as part ofa mixture

or article into the customs territory of the United States, and includes:

(i) The person primarily liable for the payment ofany duties on the merchandise, or

(ii) An authorized agent acting on his behalf (as defined in 19 CFR 1.11).

12) Importer also includes, as appropriate:.

(i)The consignee. (ii) The importer ofrecord. (iii) The actual owner ifan actual owner's declaration and superseding bondhave been filed in accordance with 19 CFR 141.20. 51715

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### No. 240 / Thursday, December 22, 1988 / Rules and Regulations

(iv)The transferee, iftheright to draw merchandise in a bonded warehouse has been transferred in accordance with Subpart Cof19 CFR Part 144.

(3) For the purposes ofthis definition, the customs territory ofthe United States consists ofthe 50 States, Puerto Rico, and theDistrict ofColumbia.

"Impurity" means a chemical substance which is unintentionally presentwith another chemical substance.

"Intermediate" means any chemical substance that is consumed, in whole or in part,in chemical reactions used for the intentional manufacture ofother chemical substances ormixtures, or that is intentionally present for the purpose ofaltering the rates of such chemical reactions.

"Known to orreasonably ascertainable by"means all information in a person's possession orcontrol, plus all information that a reasonable person similarly situated might be expected to possess, control, or know.

"Manufacture" means to manufacture forcommercial purposes. 

### .

"Manufacture forcommercial purposes" means: (1] To import, produce, or manufacture with the purpose ofobtaining an immediate or eventual commercial advantage for the manufacturer, and includes among other things, such "manufacture" of any amount Ofa.chemical substance or mixture:

(i)Forcommercial distribution, including for testmarketing.

(ii) For use bythe manufacturer, including use forproduct research and development, oras an intermediate.

(2)Manufacture for commercial purposes also applies to substances that

are produced coincidentally during the manufacture, processing, use, or disposal ofanother substance or mixture, including both byproducts that

are separated from that other substance

or mixture and impurities that remain in that substance ormixture. Such byproducts and impurities may, or may not, in themselves have commercial value.They are nonetheless produced forthe purpose of obtaining a commercial advantage since they are part ofthe manufacture ofa chemical product for a commercial purpose.

"Manufacturer" means a person who imports, produces, or manufactures a chemical substance. Aperson who extracts a component chemical substance from a previously existing chemical substance or a complex combination ofsubstances is a manufacturer ofthat component chemical substance.

"Non-isolated intermediate" means any intermediate that is not intentionally removed from the equipment in which it is manufactured, including the reaction vessel in which It is manufactured, equipment which is ancillary to the reaction vessel and any equipment through which the substance passes during a continuous flow process, butnot including tanks orother vessels in which the substance is stored after itsmanufacture. Mechanical or gravity transfer through a closed system Is not considered tobe intentional removal, but storage or transfer to shipping containers "isolates" the substance by removing it from process equipment in which Itis manufactured.

"Own or control" means ownership of 50 percent or more of a company's voting stock or other equity rights, orthe power to control the management and policies ofthat company. A company may own or control one ormore sites. A company may be owned or controlled by a foreign or domestic parent company.

"Parent company" is a company that

owns orcontrols another company.

"Person" includes any individual, firm,company, corporation, joint venture,partnership, sole proprietorship, association, or any other business entitr; any State or political subdivision thereof; any municipality; any interstate body; and any department, agency, or instrumentality oftheFederal Government.

"Possession or control" means in the possession or control of any person,or of any subsidiary, partnership in which theperson is a generalpartner,parent company,or any company or partnership which the parent company
owns or controls, if the subsidiary, parent company, orother company or partnership is associated with the person intheresearch, development, testmarketing, or commercial marketing ofthe substance in question. Information is in thepossession or control ofa person ifitis:

(1)In the person's own files including files maintained by employees ofthe person in the course oftheir employment.

(2) In commercially available data bases to which the person has purchased access.

(3)Maintained in the files in the

course ofemployment by other agents of theperson who are associated with research, development, test marketing,

or commercial marketing ofthe chemical substance in question.

"Process" means to process for commercial purposes.

"Process for commercial purposes"

means thepreparation of a chemical substance ormixture after Its manufacture fordistribution in commerce with the purpose ofobtaining



### animmediate oreventual commercial advantage for theprocessor. Processing ofany amount ofa chemical substance

or mixture is included in this definition. Ifachemical substance ormixture containing impurities is processed for commercial purposes, then the impurities alsoare processed for commercial purposes.

"Processor" means anyperson who processes a chemical substance or mixture.

"Production volume" means the quantity ofa substance which is producedby amanufacturer, as measured inkilograms or pounds.

"Propose to manufacture, import, or process" means that a person hasmade

afirmmanagement decisionto commit financial resources forthe manufacture, mport,or processing ofa specified chemical substance or mixture.

"Site" means a contiguous property unit.Property divided only by apublic right-of-way shall be considered one site.There maybe more than one plant

on a single site.The sitefora person whoimports a substance is the site of the operatingunit within the person's organization which is directly responsible forimporting the substance and which controls the import transaction andmay in some casesbe theorganization's headquarters office in theUnited States.

"-Smallmanufacturer or importer"

means amanufacturer orimporter that meets either ofthe following standards: (1) Firststandard. Amanufactureror importer ofa substance is smallifits total annual sales,when combined with thoseofitsparent company (ifany), are less than $40 million. However, ifthe annual production or importation volume ofa particular substance at any individual site owned orcontrolled by the manufacturer orimporter is greater than45,400 kilograms (100,000 pounds), the manufacturer orimporter shall not qualify as smallfor purposes of reporting onthe production or importation ofthat substance at that site, unlessthe manufacturer or importer qualifies as small under standard (2)of this definition.

(2) 

### Secondstandard. Amanufacturer

or importerofa substance is small ifits total annual sales, when combined with those ofits parent company (ifany), are less than $4million,regardless ofthe quantity ofsubstances produced or imported bythat manufacturer or importer.

(3) Inflationindex.EPA shall make

use ofthe Producer Price Index for Chemicals andAllied Products, as compiledby the U.S. Bureau ofLabor 51716.

- 

### Federal Register / Vol. 53,-

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### / Rules and Regulations 51717

Statistics, forpurposes of determining the need to adjust the total annual sales values and for determining new sales values when adjustments are made. EPA may adjust the total annual sales values whenever theAgency deems it necessary to do so, provided that the Producer Price Index for Chemicals and Allied Products has changed more than 20 percent since either the mostrecent previous change in sales values or the date ofpromulgation ofthis rule, whichever is later.EPA shall provide Federal Registernotification when changing the total annual sales values.

"Small quantities solely for research and development" (or "small quantities solely for purposes of scientific experimentation or analysis or chemical research on, oranalysis of,such substance or another substance, including such research or analysis for the development of a product") means quantities ofa chemical substance manufactured, imported, or processed or proposed tobe manufactured, imported,

or processed solely forresearch and development that are not greater than reasonably necessary for such purposes.

"Substance" means either a chemical substance ormixture unless otherwise indicated.

"Testmarketing" means the distribution in commerce ofno more than a predetermined amount ofa chemical substance, mixture, article containing that chemical substance or mixture, ora mixture containing that substance, by a manufacturer or processor, to no more than a defined number ofpotential customers to explore market capability in a competitive situation during a predetermined testing period prior to the broader distribution ofthat chemical substance, mixture, or article in

commerce.

"Total annual sales" means the total annual revenue (indollars) generated by the sale of all products ofa company. Total annual sales must include thetotal annual sales revenue ofall sites owned

or controlled by that company and the total annual sales revenue of that company's subsidiaries and foreign or domestic parent company, ifany.

"TSCA"means the Toxic Substances Control Act, 15 U.S.C. 2601 et seq. §704.5 Exemptions.

A person who is subject to reporting requirements for a substance identified in this Part is exempt from those requirements to the extent that the person and that person's use of the substance is described in this section. This section is superseded by any TSCA section 8(a) rule that adds to, removes, or revises the exemptions described in this section.

(a)Articles.Aperson who imports, processes, orproposes to import or process a substance identified in this Part solely as part ofan article is exempt from the reporting requirements ofthis Partwith regard to that substance.

(b) Byproducts.A person who manufactures, imports, or proposes to manufacture or import a substance identified in thisPart solely as a byproduct is exempt from thereporting requirements ofthis Part.

(c)Impurities.A person who manufactures, imports,processes, or proposes tomanufacture, import, or process a substance identified in this Part solely as an impurity is exempt from thereporting requirements ofthis Part. (d) Non-isolated intermediate. A person who manufactures orproposes to manufacture a substance identified in this Part solely as a non-isolated intermediate is exempt fromthe reporting requirements ofthis Part.

(e)Researchanddevelopment A person who manufactures, imports, processes, orproposes to manufacture, import, orprocess a substance identified in this Part only in small quantities solely for research and development is exempt from the reporting requirements of this Part.

(f)Smallmanufacturers and importers.Small manufacturers and importers are exempt from the reporting requirements of this Part.

5.By revising the section heading for § 704.7to read as follows: §704.7 Confidential businessInformation claims.

6. By adding §§704.9, 704.11, and 704.13 to read as follows: §

704.9 Where to send reports. Reports must be submitted by certified mail:to: TSCA Document Processing Center (TS-790), Office of Toxic Substances, U.S. Environmental Protection Agency, Room L-100,401 M St., SW., Washington, DC 20460, ATTENTION: 8(a)Reporting. §704.11 Recordkeeplng.

Each person who is subject to the reporting requirements of thisPart must retain the following records for 3 years following the creation orcompilation of the record.

(a)A copy ofeach report submitted by the person in response to the requirements ofthisPart. (b)Materials and documentation sufficient to verify orreconstruct the values submitted in the report.

(c)Acopy ofeach notice sentby the
person,return receipt requested, to that person's customers for the purpose of notifying theircustomers ofthe customer's reporting obligations under this Part.

(d)All return receipts signed by the person's customers who received the notice described in paragraph (c) ofthis section. (Approved by the Office ofManagement and Budget under OMB control number 2010- 0019) §704.13 Compliance and enforcement.

Violators ofthe requirements of this Part may be subject to civil administrative penalties up to $25,000 per day ofviolation orcriminal prosecution, as provided in sections 15 and 16 ofTSCA. In addition, under section 17, EPA may seekjudicial relief
to compel submission ofrequired information.

7.By amending Subpart Bas follows:
Subpart B-Chemical-Specific Reporting and Recordkeeping Rules

a. By revising theheading for Subpart B to read as set forth above. §§704.03,704.85,and 704.142 [Redesignated as

### §9 704.43,704.45and 704.102].

b.By redesignating existing §§704.83, 704.85, and 704.142 under Subpart B as §§704.43, 704.45, and 704.102 respectively. 

### §9 704.195 and 704.205 [Removed].

c.By removing §§704.195 and 704.205. 8.By adding Subpart Cto read as follows: Subpart C--CAIR: Comprehensive Assessment Information RuleGeneral Reporting and Recordkeeping Provisions

Sec. 704.200. Overview ofCAIR provisionsSubparts Cand D. 704.203 Definitions. 704.205 Limitations onreporting requirements. 704.206 Personswho mustreport. 704.207 Information to bereported. 704.208 Distribution ofsubstances under a trade name. 704.210 Exemptions. 704.212 Questions selected. 704.214 Coverage period. 704.215 Reporting period. 704.216 How to obtaina CAIRreporting form. 704.217 How to submitcompleted CAIR reporting forms.,

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Sec. 704.219 Confidential business information claims.
§704.200 Overview of CAIR provisionsSubparts Cand D.

Although the provisions in Subpart A ofthis Part apply to all ofPart 704, EPA
may in Subpart C and D ofthis Part modify the Subpart A provisions ofthis Part for the purposes ofrequiring reporting and recordkeeping provisions

on specified substances. In the event of

a conflict between the provisions of Subparts A and C ofthis Part, the provisions ofSubpart Cof this Part shall
govern. Subpart C ofthis Part explains the reporting and recordkeeping provisions for persons who manufacture, import, or process the substances identified in Subpart D of this Part. Subpart D ofthis Part identifies: the substances for which EPA requires the reporting ofinformation under CAIR; the persons who are required to submit the information; the questions from the CAIR reporting form that must be answered; the time period

on which to report; and the effective date ofthe final rule. The text of Subpart D ofthis Part is setout in a matrix format and uses symbols to identify

somereporting requirements. These symbols are explained in § 704.206. In addition to the matrix, Subpart D also identifies when all reporting forms must be submitted.
§704.203 Definitions.

All definitions as set forth in section 3 ofTSCA and § 704.3 apply in this Subpart. In addition, the following definitions are provided for the purposes of this Subpart.

"Coverage period" means a time-span which is I day less than 2 years, as identified in Subpart D, and is the timespan which a person uses to determine his/her reporting year. Subject manufacturing or processing activities
may or may not have occurred during the coverage period.

"Manufacturing activities" means all those activities at one site which are necessary to produce a substance identified in Subpart D ofthis Part and make it ready for sale or use as the listed substance, including purifying or importing the substance.

"Processing activities" means all those activities which include (1) preparation ofa substance identified in Subpart D of this Part after its .manufacture to make another substance for sale oruse, (Z)repackaging of the identified substance, or (3) purchasing and preparing the identified substance for use or distribution incommerce... "Repackager" means a person who buys a substance identified in Subpart D ofthis Part or mixture, removes the substance or mixture from the container in which itwas bought, and transfers this substance, as is, to another container for sale.

"Reporting Period" means the time period during which CAIR reporting forms are to be submitted to EPA.

"Reporting Year" means the most recent complete corporate fiscal year during which aperson manufactures, imports, or processes the listed substance, and which falls within a coverage period identified with a substance in Subpart D of thisPart.

"Small processor" means a processor that meets either ofthe following standards:

(1)First Standard. Aprocessor of a substance is small ifits total annual sales, when combined with those ofits parent company (ifany), are less than $40 million. However, ifthe annual processing volume ofa particular substance at any individual site owned

or controlled by the processor is greater than 45,400 kilograms (100,000 pounds), the processor shall not qualify as small for purposes ofreporting on that substance at that site, unless the processor qualifies as small under standard (2) ofthis definition.

(2) Secondstandard. A processor ofa substance is small ifits total annual sales, when combined with those of its parent company (ifany), are less than $4 million, regardless ofthe quantity of substances processed by that processor.

(3)Inflationindex.EPA shall make

use of the Producer Price Index for Chemicals and Allied Products, as compiled by the U.S. Bureau ofLabor Statistics, for purposes ofdetermining the need to adjust the total annual sales values and for determining new sales when adjustments are made. EPA may adjust the total annual sales values whenever the Agency deems it
necessary to do so, provided that the Producer Price Index for Chemicals and Allied Products has changed more than 20 percent since either the most recent previous change in sales values or the date ofpromulgation ofthis rule, whichever is later. EPA shall provide Federal Register notification when changing the total annual sales values. 

### §704.205 umitatuons on reporting requirements.

The following limitations apply to the reporting and recordkeeping requirements ofSubpart D ofthis Part.



### (a)Reporton TSCA-regulable quantities. A person must report on only thequantityof a substance that is defined as a chemical substance under TSCA section 3(2).

(b) Chemicalsubstances fromnatural

sources.A manufacturer ofa chemical substance which is mined orextracted fromminerals, ores, petroleum, natural gas, quarried nonmetallic minerals (including extraction ofsalts from
seawateror brines), coal, or atmospheric gases, orfrom any other natural source, must report only about the manufacturing steps taken, and the

uses of,that substance, and not about production ofthenatural source material orother crude precursors derived from thenatural source material. 

### §704.206 Persons who must report.



### (a) General requirements. Manufacturers, importers, and
processors must report on each substance identified in Subpart D of this Partif: they are designated in Subpart D

as a person who must report on the substance, they manufactured, imported,

or processed the substance during the coverage period designated in Subpart D for which reporting on that substance is required, and they are not otherwise exempt.

(b)Symbolsfordesignating persons whomust report. EPA will designate who must report on each substance identified in Subpart D ofthisPart by using the following symbols: (1)"M" means each person who manufactured the substance for commercial purposes.

(2) "I"means eachperson who imported the substance for commercial
purposes.

(3) '7" means each person who processed the substance forcommercial

purposes.

(4) "X/P" means eachperson who manufactured, imported, or processed the substance forcommercial purposes and distributed the substance under a tradename.

(c) Special provision forimporters. When two ormore persons are involved in a particular Import transaction ofa substance identified in Subpart D of this Part, and two or more ofthese persons meet the definition of "importer" for this transaction, theymay determine among themselves who should comply with the CAIR reporting and recordkeeping requirements forthe substance andhave thatperson list thenames ofthe other importers who were involved in the transaction. Ifnone of thepersons involved comply with the CAIR reporting and recordkeeping -requirements for that substance, then EPAwill hold each ofthese persons liable for their failure to comply.

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(d)Dual designations. Ifa person is engaged inmore than one activity (e.g., manufacturing and processing) at the

same site for a substance identified in Subpart DofthisPart and both activities are listed, then that person must comply with the reporting requirements forboth activities.
§704.207 Information to be reported.

(a) The CAIR reporting form is comprised of10 sections. Each section contains specific questions which pertain to the subject matter found in that particular section.There is a set of instructions which accompanies the CAIR reporting form. The instructions consist of: specific directions and sample answers relating to certain form questions based on two reporting scenarios, conversion tables, and a glossary which defines key terms. The following is a description ofthe information contained in each section of the CAIR reporting form.

(1)Section 1: General Manufacturer, Importer, andProcessor Information. Respondent Identification Reporting Status Certification Statements Corporate Data Mixture Identification

(2) Section 2: Manufacturer, Importer, andProcessorVolume,andUse. Respondent Activities Quantity Manufactured, Imported, and

Processed Quantity Exported Quantity Stored on-site Product Types Transportation off-site Customer Use

(3)Section 3:Processor RawMaterial Identification. Quantity Used and Price ofListed

Substance Transportation to Site Listed Substance in the Form ofa

Mixture (4) Section 4:Physical/Chemical Properties. Purity ofListed Substance MSDS Exists/Submitted Physical State ofListed Substance Particle Size ofListed Substance Fire,Explosion, and Other Hazard Data Shipment Restrictions

(5) Section 5:EnvironmentalFate. Rate Constants andTransformation

Products Partition Coefficients

(6) Section 6:Economicand Financial Information. Company Type Product Types/Product Markets Commercially Available Substitutes Production Costs Product Sales (7) Section 7:Manufactureand Process Information.
Process Block Flow Diagrams Unit Operation Equipment Types Process Stream Description and

Characterization (8) Section 8:Residual Treatment, Generation,Characterization, Transportation, andManagement. Residual Treatment Block Flow

Diagrams Unit Operation Equipment Types Process Stream Description and

Characterization Residual Management Methods Residual Handling Instructions/

Restrictions Storage or Treatment inTanks and

Waste Piles Storage, Treatment, or Disposal in

Containers Residual Handling Burning in Boilers and Incinerators Storage, Treatment, or Disposal in Land

Treatment Sites and Surface Impoundments Disposal in Landfill Cells and Injection

Wells (9) Section 9: WorkerExposure. Employment and Potential Exposure

Profile Records Maintained forWorkers Job Titles by Labor Category Exposure Characterization

- Process Block Flow Diagram with

Associated Work Areas Description ofWork Areas and Worker

Activities Work Place Monitoring Programs Personal/Ambient Air Monitoring Medical, Monitoring Tests Engineering Controls Equipment/Process Modifications Personal Protective Clothing and Safety

Equipment Respirator Maintenance Activity and

Training Programs Work Practices Housekeeping Tasks Medical, Leak, Spill, Worker Safety, and

Health Plans (10) Section 10: Environmental Release. Plant Location Meteorological Conditions Groundwater Below Plant Site Routine Releases Quantity ofListed Substance Released Control Technologies Point Source Emissions Emission Characteristics Equipment Leaks and Detection Pressure Relief Devices with Controls Raw Material, Intermediate, and Product

Storage Emissions NPDES, POTW, and Non-point

Discharges Releases to Soils, Groundwater, and Drinking Water Spills and Other Non-routine Releases Weather Conditions, Date and Time of

Release Method ofRelease and Quantity

Released Cause andResult ofRelease Authorities and Population Notified Personal Injuries and Casualties Release Prevention Practices Repairs and/or Preventative Measures

(b) [Reserved]
§704.208 Distributionof substances underatrade name.

(a)The X/P designation requires each person who manufactured, imported, or processed a substance identified in Subpart D of thisPart for conunercial purposes and who distributed the substance under a trade name to do one ofthe following.

(1)Tradenamelist. Submit toEPA a list ofall trade names under which the person distributes the substance. Submissions must have a postmark date

no later than I day after the effective date ofthe final rule listing the substance in Subpart D ofthis Part. Trade name lists mustbe submitted by certified mail to: TSCA Document Processing Center (TS-790), Office of Toxic Substances, Environmental Protection Agency, Room L-100, 401 M St., SW., Washington, DC 20460, ATTENTION: CAIR Trade Name List. Include the date ofthe Federal Register notice you are subject to, the substance
name, CAS number, trade name(s) associated with that substance, the company's name, address and telephone number, and the address and telephone number ofa technical contact. EPA will issue all submitted trade names in a Federal Register notice in orderto notify all processors of these trade name substances of their CAIR reporting and recordkeeping obligations.

(2) Customerreporting.Submit to EPA

a CAIR reporting form that answers the processor's reporting requirements for each customer who would be required to report ifthe customer knew it was processing the listed substance. Persons may only choose to report for their customers ifsuch persons can supply all ofthe information requested. Persons reporting on their customers' activities

are liable forinformation reported incorrectly just as they are for reporting incorrectly on theirown activities. Reporting is due no later than 90 days after the effective date of the final rule listing the substance in Subpart D of this Part.

(3)Customer notification.Notify each customer who would be required to Federal Register / Vol. 53, No. 246 / Thursday, December 22, 1988 / Rules -and Regulations 51719

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### 51720 Federal Register / Vol. 53, No. 246 / Thursday, December 22, 1988 / Rules and Regulations

report ifthe customer knew they were processing the listed substance, of the specific section in Subpart D of thisPart which identifies the substance and the processor reporting requirements. The
customer notification must be sent by certified mail, return receipt requested, within 30 days ofthe effective date of the final rule that added the substance
toSubpart D ofthis Part.The notification must specify which questions from the form mustbe answered, on which tradename. substances, when the reports are due, the citation and date ofthe final rule that added the substance to Subpart D, and where to send the reports. Customers must report within the time period indicated in §704.223(b).

(b)Notificationextensions.Any
person who chooses tonotify their
customers oftheir reporting obligations, but cannot meet the notification deadline, may apply for a reasonable extension oftime.Requests for extensions must be made in writing, contain a justification for such a request, and be addressed to: TSCA Document Processing Center (TS-790), Office of Toxic Substances, U.S. Environmental Protection Agency, Room L-100, 401 M St., SW., Washington, DC20460, ATTENTION: CAIR customer notification extension. Extension requests mustbe postmarked no later than 5 days before the notificationdeadline.

(c) [Reserved] 

### §704.210 Exemptions.

The reporting exemptions set out in §704.5 apply to CAIR reporting requirements. This section contains additional exemptions from reporting that also apply to CAIR reporting requirements. EPA may modify exemptions for CAIR reporting requirements for specific substances by specifying the modification in Subpart D of this Part.

(a) Repackager. Aperson who is solely a repackager as defined in §704.203, and does not engage in any other processing activities, is exempt from the reporting and recordkeeping requirements ofthis Subpart.

(b) Smallprocessor. A person who qualifies as a small processor as this
term is defined in J704.203 is exempt from the reporting and recordkeeping requirements ofthis Subpart.

(c)Previoussubmissionof data.(1)

### A submitter who previously provided information on a substance identified in Subpart D of this Part to EPA or another Federal agency on a CAIR reporting form qualifies for a partial exemption from current reporting requirements for that substance and site ifthe person previously reported voluntarily or pursuant to previous reporting and recordkeeping requirements ofthis Subpart. The previously submitted report must have covered a complete corporate fiscal year that ended no more than 3 years before the effective date of the current reporting requirements for the substance, and the data on the previously submitted CAIR formmust be current, accurate, and complete for the reporting year determined using the
coverage periods specified in Subpart D ofthis Part.

(2) Ifthe submitter qualifies forthis partial exemption because the submitter previously submitted information voluntarily to EPA or another agency, then that person may, in response to a specified reporting requirement on a substance identified in Subpart D of this Part, submit only a completed Section'l ofthe CAIR reporting form and a copy of the previous submission. To use this partial exemption, the person must sign the certification set out in Section 1of the CAIR reporting form that pertains to the use of this exemption.

(3) Ifthe submitter qualifies forthis partial exemption because the submitter previously submitted information to EPA pursuant to reporting requirements ofthis Subpart, then that person may, in
response to a specified reporting requirement on a substance identified in Subpart D ofthis Part, submit only a completed Section I ofthe CAIR reporting form and indicate the date of and the technical contact for the previous submission. To use thispartial exemption, the person must sign the certification set out in Section 1 ofthe CAIR reporting form that pertains to the

use ofthis exemption.
§704.212 Questionsselected.

(a)Designated questions.Each person who is required toreport on a substance identified in Subpart D of this Part must

answer only the CAIR reporting form questions designated in Subpart D. A CAIR reporting form and instructions

can be obtained from the TSCA Assistance Office as outlined in § 704.216.

(b)Specifying the questions.(1) The questions selected will always include Section 1ofthe CAIR reporting form.

(2) Other questions selected will be specified by section or question number (e.g., 3 all or3.01 and 3.02).

(i)Whenever the questions selected specify a section of the CAIR reporting. form followed by the word "all," each
person who is required to report on the identified substance must answer all parts ofeach question within the section. (ii)Whenever the questions selected specify a question from the CAIR reporting form, each person who is required to report on the identified substance must answer all parts ofthe question. (c) Onereport persite.Each person who is required to report on a substance identified in Subpart D ofthis Part must report therequired information separately for each site at which that person manufactured, imported, or processed the substance.

(d)Activitieson which to reportEach person who is required to report on a substance identified in Subpart D ofthis Part mustreport the required information for each activity which

occurs at the site.If a person is engaged inmore than one activity (e.g., manufacturing and processing) at the

same site with respect to the substance, such person is only required to report on the activity or activities specified in Subpart D. Ifa person is required to report on more thanone activity for the

same substance, such person must report on all specified activities on the

same form.
§704.214 Coverage period.

(a) Each person who is required to report on a substance identified in Subpart D of this Part must comply with the reporting requirement for the coverage period designated in the Subpart D matrix.

(b)EPA will specify for each reporting requirement the coverage period on which the information mustbe reported.

(c) Activities which occurred during a coverage period are reportable ifthey occurred during thereporting year.

(d) Persons who were engaged in reportable activities in more than one coverage period mustreport only on the
mostrecent coverage period in which the activities occurred.
§704.215 Reporting perod.

(a) When reportsaredue.(1 Persons who are required to report on a substance identified in Subpart D ofthis Part,including those who choose to report for their customers who process the identified substance, must submit their completed CAIR forms during the reporting period identified in §704.223(a).

(2) Persons who were notified by a supplier that reporting is required on a trade name substance, must submit their completed CAIR forms during the reporting period identified in §704.223(b).

(b)Reportingextensions.Persons who
cannot submit their reports by the deadline as specified in 

### §704.223 may

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## / Rules and Regulations 51721

apply fora reasonable extension of time. Requests for extensions mustbe made in writing, contain ajustification for such requests, and be addressed to: TSCA Document Processing Center {TS790), Office ofToxic Substances, U.S. Environmental Protection Agency, Room L--100, 401 M St., SW., Washington, DC 20460, ATrENTION: CAIR reporting extension. Extensionrequests must be postmarked no later than 30 days after the effective date oftheaddition ofa substance or mixture to Subpart D of thisPart or30 days after notificationby

a supplier as described in J704.208.
§704.216 Howto obtaina CAIR reporting form.

CAIR forms and instructions may be obtained by telephoning orwriting the TSCA Assistance Office. Phone Number (202) 554-1404, TDD (202)554- 0551. Address: TSCA Assistance Office (TS-799), Office ofToxic Substances, Environmental Protection Agency. 401 M St., SW., Washington, DC 20460. §704.217 How tosubmit completed CAIR reporting forms.

(a) Eachperson who is required to report on a substance identified in Subpart D ofthisPart may submit their reports from the individual sites or through the companyheadquarters. However, a separate report must be submitted for each substance ateach site at which theperson engages in one
ormore ofthe activities for which EPA is requesting information.

(b) Submitters must send their completed forms to: TSCA Document Processing Center (TS-790), Office of Toxic Substances, U.S. Environmental Protection Agency, Rm. ,-100,401 M St., SW., Washington, DC 20460. ATTENTION: CAIR Reporting.
§704.219 Confidential business information claims.

(a) Submitters may assert a Confidential Business Information (CBI) claim forinformation submitted In EPA onlyif: the claim is asserted in accordance with this section; and release ofthe information wouldreveal trade secrets or confidential commercial

orfinancial information, as provided in section 14(a) ofTSCA. EPA will place all information not clained as confidential in themanner described in this section in the publicfilewithout further notice totherespondent (b) Submitters who assert a CBI claim for submitted information mustprovide EPA with two copies oftheir submission. The first copy must be complete and contain all information being claimed as confidential. The second copy must contain only information not claimed as confidential. EPA willplace the second copy ofthe submission in the public file. Failure to furnish a second copyof the submission when information is claimed as confidential in the first copy will be considered a presumptive waiver ofthe claim of confidentiality. EPA will notify the submitter by certified mail that a finding ofa presumptive wavier of the claim ofconfidentiality has been made. The submitter has 30 daysfrom the date ofreceipt ofnotification to submit the. required second copy. Failure to submit the second copy will cause EPAto place the first copy in the public file.

(c) Submitters may assert CBI claims only at the time a completed CAIR form is submitted and only in the specified

manner.

(1) Submitters must clearly mark all information claimed as confidential. Submitters can claim information submitted on a reporting form as confidential by placing in the CBI box. which is adjacent to the question, the letter orletters that indicate the category of the information, as enumerated in paragraph (e) of this section, which isbeing claimed confidential. Respondents who claim information submitted on continuation sheets to the form as confidential must do soby writing the word "Confidential" at the top ofthe page on which the information appears and by placing brackets ([ ]) around the information claimed confidential.

12) [Reserved] (d)Submitters must substantiate all claims ofconfidentiality at the time the submitter asserts the claim (i.e., when the reporting form is submitted). Failure
to provide substantiation of a claim at the time the submitter submits the reporting form will result in a waiver of the confidentiality claim, and the information may be disclosed to the public without further notice to the submitter.

(e) EPA has identified six information categories as those which will
encompass all claims ofconfidentiality:
Submitter identity=h. Substance identity=i, Volumemanufactured, imported, or

processed=j, Use information=k, Process information=l, and Other information=m. Submitters who assert a CBlI claim on the reporting form must mark the letter

orletters (hthrough m) that represent the appropriate category(ies) of confidentiality for theinformation in the box adjacent to the question. Confidentiality claims for information

on continuation sheets are asserted by placing the appropriate letter(s) inthe margin by the information claimed confidential.

(f)Submitters who assert any CBI claims must substantiate all claimsby completing all applicable portions ofthe CBI substantiation form found in Appendix IIofthe CAIR reporting form.

9. Subpart D is added to read as follows:
Subpart D-CAIR Specific Reporting and Recordkeeping Requirements

Sec. 704.220 Chemical substance matrix requirements. 704.223 Reporting period. 704.225 Chemical substance matrix by CAS .registry number.

§704.220 Chemical substance matrix requirements.

For each substance listed in the matrix in §704.225, EPAhas identified thepersons who must report on that substance by means ofthe symbols M, I. P,and X/P.An-explanationofthese symbols is givenin §704.206 ofSubpart C ofthis Part.These designated persons mustrespond to all of the matrix's reportingrequirements. All of the CAIR reporting and recordkeeping requirements areexplained in Subpart C ofthis Part. Persons who are required to report must comply with Subpart C of this Part. §704.223 Reporting period.

(a) Reports must be submitted to the Agency no latter than 90 days after the effective date ofthe final rule listing the substance in §704,225, except as described in § 704.223(b).

(b) Personssubject to X/P designations and who chose to notify their customers, must inform their customers that reports are due within 90 days ofreceipt ofnotification.

§ 704.225 Chemical substance matrix by CAS registry number.
The following codes are used in this section.

M =Each Person who Manufactured the Substance for Commercial Purposes

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1=Each Person who imported the Substance for Commercial Purposes P=Each Person who Processed the Substance for Commercial Purposes X/P=Each Person who Manufactured, Imported, or Processed the Substance for Commercial Purposes and Distributed the Substance under a Trade Name (a)List of Chemicals.

ExempWho lions CAS No. chemical name must added Coverageperiod Questions selected Effective date removed

_____________ _________________________________ 

## -)

______________________ ______________________ _____(-)_____

Hydrazinecarboxamide

..........................
Acetamide (Ethanamide).......................

79-27-6

.......... Ethane, 1,1,2,2-tetrabromo-

.............
85-01-8

.... Phenanthrene

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

Benzene, 1,3-diisocyanato-2-methyl-

(2,6-Toluene dilsocyanate).

2-Naphthalenesulfonic acid, 6-amino.

(Broenner's acid).

Benzenamine, 4,4'-methylenebis[2-

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

(Tds(2-chloroethyl) phosphate). X/P, P.I......

M,I...........

M,I...........I

X/P, P



### .........

Pyrene (Benzo~def]phenanthrene)

...... M.I

. ..... 91-08-7

.........

93-00-5

........

101-14-4

......

115-98

........

129-00-0

........

563-41-7

........

584-84-9

...... X/P, P
......... 57-56-7

.........
60-35-5

......... M,X/P, I,P. M,I

.........

M,X/P,

I,P. M,X/P,

I,P. 2/8/87-2/5/89

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2/8/87-2/5/89 1,2.08, 2.12, 2.13, 9.02, 9.03, 9.06 1,2.01, 2.04 thru 2.06,

2.08, 2.12 thru 2.14, 2.17, 3.04, 9.04 thru 9.07

1,2.08.2.12, 2.13

1,2.01, 2.03, 2.05 thru

2.08, 2.11 thru 2.14, 2.16, 2.17, 9.02, 10.05, 10.08 1, 2.04 thru 2.09, 2.11

thru 2.16, 3 all, 4.01 thru 4.05, 5 all, 6.05, 7.01, 7.03 thru 7.06, 8.01, 8.05, 8.06, 8.23,

9.01 thru 9.15, 9.19, 9.20, 9.22, 10.01, 10.02, 10.05, 10.08 thru

10.16, 10.23 1, 2.04 thru 2.09, 2.11

thru 2.16, 3 all, 4.01 thru 4.05, 5 all, 6.05, 7.01, 7.05, 7.08, 8.01, 8.05, 8.06, 8.23, 9.01 thru 9.15, 9.19, 9.20,

9.22, 10.01, 10.02, 10.05, 10.09 thru 10.16,

10.23 1,2.01, 2.04 thru 2.06, 2.08, 2.11, 2.12, 2.17, 3.04, 4.01, 9.07, 10.05,

10.08 1, 9.01, 9.03, 9.06, 9.08,

9.12, 9.15 1,2.01, 2.03, 2.05 thru

2.08,2.11 thru 2.14, 2.16, 2.17, 9.02, 10.05, 10.06 1, 2.01, 2.03, 2.05 thru

2.08,2.11 thru 2.14, 2.16, 2.17, 9.02, 10.05, 10.06 1,2.08, 2.12, 2.13, 9.02,

9.03, 9.06

1, 2.04 thru 2.09, 2.11

thru 2.16, 3 all, 4.01 thru 4.05, 5 all, 6.05, 7.01, 7.03 thru 7.06, 8.01, 8.05, 8.06, 8.23,

9.01 thru 9.15, 9.19, 9.20, 9.22, 10.01, 10.02, 10.05, 10.08 thru

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2/6/89 Hydrazinecarboxamide, monohydrochloride (Semicarbazide hydro- chloride). Benzene, 2,4-dlisocyanato-1-methyl..

(2,4-Toluene diisocyanate). M,X/P, !,

P.

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Who EnP

CAS No. Chemical name m dded Coverage period Questions selected Effective date report removed

Disuffide, dimethyl (Dimethyl disulfide).

Benzene, diisocyanatomethyl- (Un-

specifictoluene dilsocyanate).

Hydroxylamine, hydrochloride (Hydroxylammonium chloride).

Chlorine

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

Hydroxylamine (Oxammonium)

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

Hydroxylamine, sulfate (2:1) (Hydroxylammonium).
Hydroxylamine, sulfate (1:1) (Hydroxylamine acid sulfate).

Benzene, 1,3-diisocyanatomethyl

(Toluene disocyanate). M 

### ., . ..... .................

X/P, P

.............. 624-92-0

........

1321-38-6

......

5470-11-1

......

7782-50-5

.....

7803-49-8

......

10039-54-0

..

10046-00-1...

26471-62-5...

M.I........................ M,I

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9.22, 10.01, 10.02, 10.05, 10.09 thru 10.16,

10.23 1, 2.01, 2.03, 2.05 thru

2.08, 2.11 thru 2.14, 2.16, 2.17, 9.02, 10.05.

10.06 1, 2.04 thru 2.09, 2.11

thru 2.16, 3 all, 4.01 thru 4.05, 5 all, 6.05, 7.01, 7.03 thru 7.06, 8.01, 8.05, 8.06, 8.23,

9.01 thru 9.15, 9.19,

9.20, 9.22, 10.01, 10.02, 10.05, 10.06, 10.08thru 10.16, 10.23 1, 2.04 thru 2.09, 2.11

thru 2.16, 3 all, 4.01 thru 4.05, 5 all, 6.05, 7.01, 7.05, 7.06, 8.01, 8.05, 8.06, 8.23, 901 thru 9.15, 9.19, 9.20,

9.22, 10.01, 10.02, 10.05, 10.06, 10.09 thru

10.16, 10.23 1,2.07, 2.12 thru 2.14,

3.04, 6.03 thru 6.05, 9.01 1,2.05 thru 2.07, 2.11,

4.01, 7.03 thru 7.06, 10.02, 10.08 1,2.07, 2.12 thru 2.14,

3.04, 6.03 thru 6.05, 9.01 1, 2.07, 2.12 thru 2.14,

3.04, 6.03 thru 6.05, 9.01 1,2.07, 2.12 thru 2.14,

3.04, 6.03 thru 6.05, 9.01 1, 2.04 thru 2.09, 2.11

thru 2.16, 3 all, 4.01 thru 4.05, 5 all, 6.05, 7.01, 7.03 thru 7.06, 8.01, 8.05, 8.06, 8.23,

9.01 thru 9.15, 9.19, 9.20, 9.22, 10.01, 10.02, 10.05, 10.06, 10.08 thru 10.16, 10.23

1,2.04 thru 2.09, 2.11

thru 2.16, 3 all, 4.01 thru 4.05, 5 all, 6.05, 7.01, 7.05, 7.06, 8.01, 8.05, 8.06, 8.23, 9.01 thru 9.15, 9.19, 9.20, 9.22, 10.01, 10.02, 10.05, 10.06, 10.09 thru

10.16, 10.23

(b) lReserved] FRDoc. 88-26445 Filed 12-21,-88; 8:45 am]
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M, X/P,

I,P. 

## M

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

M, X/P,

1,P.

M,

X/P, I,P. M,X/P,

t,

P.
X/P, P

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

..........

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