### Federal Register / Vol. 47, No. 120 / Tuesday, Tune 22, 1982 / Rules and Regulations

ENVIRONMENTAL PROTECTION
AGENCY

40 CFR Part 712
[OPTS-82004F; FRL 2039-7]

Chemical Information Rules; Manufacturers Reporting; Preliminary Assessment Information

AGENCY. Environmental Protection Agency (EPA). ACTION: Final rule.

SUMMARY: This final Preliminary Assessment Information rulerequires chemical manufacturers (including certain producers and importers) to submit information on approximately 250 chemicals. The information sought from manufacturers includes data on the quantities ofchemicals manufactured, the amounts directed to certain classes ofuses, and the potential exposures and environmental releases associated with the manufacturer's own and his immediate customers' processing ofthe chemicals. The information collected under this rule will answer a critical need for basic data that can be used in setting priorities for testing chemicals and for assessing risks associated with chemicals. EFFECTIVE DATE: 

### This regulation becomes effective on July 22, 1982.

FOR FURTHER INFORMATION CONTACT. Forfurther information on thisrule, or to obtain copies ofthe Manufacturer's Reporting Form, contact: Douglas G. Bannerman, Acting Director, Industry Assistance Office (TS-799], Office of Pesticides and Toxic Substances, Environmental Protection Agency, Rm. E-511B, 401 M St., SW,Washington, DC 20460, Toll-free: (800-424-9065), In Washington, DC: (554-1404), Outside the USA: (Operator-202-544-1404).

SUPPLEMENTARY INFORMATION: OMB ControlNumber: 2000-0420.

I.Introduction

Proposed amendments to this final rule arepublished elsewhere in this issue ofthe Federal Register.

EPA proposed a rule under section 8(a) ofthe Toxic Substances Control Act (TSCA) to obtain general use and
exposure data on 2,226 chemical substances published in the Federal Register ofFebruary 29, 1980 (45 FR 13646). More than 150 written comments

were received on the proposal and several meetings were held with members ofthe public. The Agency also received a petition from the Chemical Manufacturers Association requesting that the Agency provide dossiers and other information on the 2,226 chemicals for purposes ofpublic comment. EPA responded to the petition in the Federal Register ofApril 28, 1980 (45FR 28173). This preamble explains the final rule's provisions and addresses by topic the changes EPA has made to simplify, clarify, and reduce the burden of the rule. A document titled "Responses to Individual Comments" responds to substantive comments individually.This document is available to the public in the administrative record ofthis rulemaking and is considered to be incorporated byreference here. Some
comments are not discussed because changes in the final rule,particularly changes in subject chemicals, have made the issues moot.

After considering comments, the Agency has changed certain provisions and significantly reduced the number of chemicals. The changes to the provisions will reduce the burden of reporting without greatly decreasing the value ofthe information that the rule will collect on each chemical. Also in
response to comments, the Agency has added explanatory material to clarify the requirements. Because of these changes, the Agency has changed the format ofthe final rule. Therule is now arranged in three Subparts. Subpart A contains general provisions applicable
to the entire Part. Subpart B contains reporting requirements forchemical manufacturers. Subpart Cwill contain the chemical processors' reporting requirements proposed separately today.This arrangement should allow manufacturers and processors to more easily identify the provisions to which they are subject.

Elsewhere in thisissue ofthe Federal Register,EPA is proposing three amendments to this final rule. One amendment is the plan for follow-up reporting by processors. Another change wouldrequire reporting automatically within 60 days on chemicals recommended for testing under section 4 ofTSCA by the Interagency Testing Committee (ITC).The third change would make about 50 additional ITCrecommended chemicals subject to reporting under this rule.These chemicals were listed in ITCreports 5 through 9.

A. Rule Design:Two Part Reporting
The final rule anticipates two rounds ofreporting. In the first round, manufacturers ofchemicals listed in § 712.30 ofthe rule must submit Preliminary Assessment Information Manufacturer's Reports. The reports must be submitted to EPA within four months ofthe effective date of the rule.

The manufacturer's report includes items on the use ofa manufacturer's 

### chemical byhis customers, when the customers are also processors ofthe chemical. However, manufacturers may report "unknown" fortheir processorcustomers' uses either when manufacturers do not know the customers' uses to within ±50percent accuracy, or when theinformation is subjectto a secrecy agreement between themanufacturer and customer.

The Agency will aggregate the
customer use data for each chemical. If manufacturers report customer uses unknown forover 20 percent ofthe total amount ofa chemical manufactured and imported, theAgency plans to initiate a second roundofreporting, this time by processors, in orderto complete its
assessments. As noted above, the procedures forthis second round of reporting are proposed forcomment in a separate notice today.
B.Purpose oftheRule
The information collected under this rulewill answer a critical need forbasic data that canbe used in setting priorities for testingchemicals and for assessing risks associated with chemicals.

For the majorityofthechemicals presently listed,ITChas recommended that EPApropose testing rules. Under TSCA section 4, within 12 months of ITC'srecommendation, EPA must initiate rulemaking fortesting orpublish

a notice explaining why a testrule is not necessary. Information onpotential exposure is needed for the decision. Unfortunately, available exposure information has rarely been adequate fora decision. As a result, EPA has had problems making the decisions required by statute. This rule will allow testrule decisions to be based on more complete and accurate potential exposure data.

A fewchemicals on therule were identified by public notices of substantial risk under TSCA section 8(e). Forthe listed 8(e) chemicals, EPA doesnot have sufficient exposure information to determine the extent of risks presented. When this rule provides the exposure data, EPAwill be able to evaluate and recommend appropriate action for these 8(e) substantial risk notices.

We have changed the focus ofthefirst edition of the rule to serve onlythe most immediate needs for assessment,oftest candidates and 8(e) reports. Therefore,

we eliminated from therule those chemicals proposed for purposes of general problem identification. These include chemicals proposed because of their high production volume, chemicals which theITC has been unable to completely evaluate because oflack of 26992

### Federal Register / Vol. 47, No. 120 / Tuesday, June 22, 1982 / Rules and Regulations

exposure data, and a smallnumber of chemicals from other sources described in thenotice ofproposed rulemaking. 

### I. Who MustReport
A. PersonsIncluded

1.Manufacturers. The term "manufacture" underTSCA includes importing and producing as well as manufacturing activities. Persons must report on each listed chemical substance that theymanufactured forcommercial purposes inthereporting period specified for the chemical. Discussion of the application ofthis rule toproducers and importers follows.

2.Producers-Miners andoilrefiners. Questions were asked duringthe comment period aboutthe application of this rule to mining ofchemical substances. The concern was that listed chemical substances are present in mined substances in variable or undefined concentrations and that a single chemical substance maybe reported as "manufactured" more than

once in the stream ofcommerce. Commenters felt thatit must be made clear precisely at what pointthey are "manufacturing" a specific chemical substance that is present in a mined substance. We have provided clarification both here and in the rule.

Any method ofextraction, refinement,

orpurification ofthemined substance to make itmarketable as a listed chemical substance is to be regarded as "manufacture of alisted chemical substance" for thepurposes of thisrule. Anundefined or variable concentration mixture notintended formarketing as a listed chemical is not subject to this rule.

In general terms, mining canbe regarded as extracting a substance from the atmosphere, earth, orsea. Themost

common methods are digging ores and drilling oil.Many persons mine complex substances containing listed chemicals in undefined or variable concentrations, but do notrefine the mined substance in order to extract a particular chemical substance for use orsale. Some ofthe chemicals subject to this rulemay be present in and produced from these complex precursor substances. However, because EPA has excluded undefined, variable composition substances from the listofchemicals subject to this rule, production ormining oftheundefined, variable composition precursor is not tobe reported. Only subsequent steps devoted to production ofthelisted chemical are reportable.

For example, persons who manufacture a chemical substance such

as "sweetened naphtha, 64741--87-3," but do not refine the naphtha to produce "hexane, 110-54-3" would notreport on hexane. Only theproduction of "hexane" as an isolated product mustbe reported-not previous production of

more crude, complex substances such as the naphtha fromwhich hexane is extracted.

3.Importers.Persons mustreport on any chemical substance listed in §712.30 that they imported in bulk for commercial purposes during the reporting period.

Importers shouldreport chemical substances imported in bulk in any grade ofpurity, in aqueous solution, or containing additives (such as stabilizers

orother chemicals) to maintain the integrity orphysical form ofthe substance. Thisdoes not include formulated mixtures oftwo ormore chemicals that are not additives.

The chemicals thatmust bereported

are thosethat are marketed and used as
a chemical listed in §712.30. Such chemicals were identified by name and CAS number on theInventory regardless ofpurity and mustbe reported for this rule as chemical substances. The additives, forexample, are merely to enhance the ability to use the single major component chemical, as with antioxidants. Itis still the chemical substance per se that is beingmarketed and used, and that must be reported for thisrule.

EPA interprets TSCA to provide that importers ofmixtures are importers of any chemical substance contained in such mixtures. Alternatively, to the extent that suchproducts may technically be considered mixtures as defined underTSCA, EPAhas determined that effective enforcement of TSCA requires us to obtain data on such products. This is because a chemical substance in aqueous solution or containing additives is used as the chemical substance per se, and such products may account for a substantial amount ofexposure to thechemical.

B.ExemptionsFromReporting

Most ofthe comments supported the exemptions to reporting in the proposed rule.The proposed exemptions have been adopted. In addition, thefinal rule contains an exemption suggested by commenters to exclude reporting on the manufacture ofless than500 kilograms annually at a plant site.The Agency estimates that thisexemption will exclude about 170reports. Excluding reports ofthese small production quantities will not affect assessment of the chemicals and so will relieve an unnecessary reporting burden.
III. Reporting Form forManufacturers

A facsimile ofthe Manufacturer's Report-Preliminary Assessment Information form appears in §712.28. The data reporting section ofthe form (Section IV) has two parts: Part A: Plant Site Activities and Part B: Chemical Substance Processing by Customers. Pioduction, processing, and use at each single domestic manufacturing site must be reported on Part A, including the number ofworkers, uses, and process types employed, and quantities ofthe chemical that are or are not recovered. Part B ofthe form applies to the processing ofthe chemical by others. Part B will account forthe quantity of chemical that is distributed from the manufacturing plant site. Altogether, the form identifies where a chemical is made and in what quantities, how many workers are potentially exposed during manufacture, processing, and use at the manufacturing plant site, what likely environmental releases exist, and what quantities are used in various categories ofuses both by the manufacturer and as the chemical moves into commerce.

In PartA, items I and 2 ask fortotal quantities ofthe chemical imported and domestically manufactured. Item 3

covers quantities lost during manufacture. Items 4, 5, 6, and 7 askfor quantities, worker-hours, and number of workers associated with enclosed, controlled release, and open process categories. Item4 covers manufacture of the chemical; item 5 covers on-site use

as a reactant; item 6 covers on-site nonreactant use; and item7 covers on-site preparation ofproducts. Item 8 asks how much ofthe chemical the manufacturer makes intoproducts to be used by industry orby consumers; these products include the chemical itselfand mixtures containing the chemical, articles with somerelease ofthe chemical possible, and articles with no release. All of the above Part A items

concern the manufacturer's own activities and use ofhisown products.

Part B concerns the activities ofthe manufacturer's immediate customers (processors). Item 9 parallels item 8 of Part A; it asks how much ofthe chemical the customer makes into products to be used by industry orby consumers in various forms.Item 10 asks for the trade name(s) under which the manufacturer markets the chemical to his customers. This item is only tobe answered ifthe manfacturer reports thathis customers'

uses are unknown formore than 20 percent ofthe quantity ofchemical manufactured and imported. Item 11 asks the manufacturer to estimate, based upon hisgeneral knowledge of industry practices, the quantity ofthe chemical that is processed by his
customers in enclosed, controlled, or open processes, respectively. 

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A. ReadilyObtainable Data TSCA section 8(a) authorizes EPAto require information that is "known to or reasonably ascertainable by"the respondent. This is defined at §712.3(g)

as "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, or could obtainwithout unreasonable burden." Forpurposes ofthis section 8rule, the Administrator has determined that a lesser standard should apply.

The rulerequires persons to report data that are readily obtainable by management and supervisory employees responsible for manufacturing, processing, distribution, technical services, marketing, and other related activities. These knowledgeable people

are responsible for providing estimates and associated accuracy levels forthe data elements on theform. The comments supported this standard.

B.Accuracy forReporting The proposal discussed options for the accuracy to be required for reporting quantities of a chemical under the rule. Asthe proposal stated,exact numbers will not be required. We consider that permitting estimates tobe reported will provide data sufficient for the purposes ofthis rule and will make the reporting easier. Comment was requested on various options for the required accuracy. These were: accuracy of ±50 percent forall quantities; accuracy of ±10percent or ±20percent on a person's own activities and ±50percent

on others' activities; or allowing respondents to specify the accuracy. We have decided that the accuracy should be related to the activity reported. For most ofPart A oftheform, dealing with

a manufacturer's own activities, estimates mustbe the best estimates fromreadily obtainable data,but no specific accuracy range willbe required. For items 3b, 3c, and 3drelating to losses during manufacture, accuracy mustbe specified by the respondent. For PartBof theform, dealing with processor-customers' activities, quantities mustbe reported within ±50 percent.

We are persuaded that manufacturers mustroutinely know their own production efficiencies and quantities in order to control their costs and price theirproducts. Thus, when manufacturers report about their own activities, thebest estimate from readily obtainable data wouldbe sufficiently accurate. There is no need for the company to expend further effort to report more exactly. Forexample, itwill be legitimate for a company to report figures based on design capabilities ofa process. Thus ifa process is planned to utilize orproduce a certain quantity per

..run" or per unit time, oris planned to produce a certain quantity ofproduct from a defined quantity offeedstock material, then the company may assume that the design quantities are the actual quantities, and not attempt to account for variations.

Most ofthe companies who commented favored the broadest possible limits on accuracy ofquantities reported. Except for the questions relating to losses during manufacture and customer activities, companies simply endorsed broad limits without discussion. They cited no specific difficulties in reporting on quantities going into and coming out oftheir own production processes. One commenter in fact said, "Ifwe do it, we know it." The Agency has concluded that reporting on the basis ofreadily obtainable data will
not impose significant burdens.

Based on review ofcomments and our intention to ease the reporting burdens, the final rule allows estimates for worker-hours and numbers ofworkers,

as well as for quantities of the chemicals
to which workers will be exposed. The estimates for worker-hours and number ofworkers should be based on readily obtainable data.

Items 3a, 3b, 3c, and 3d deal with losses during manufacture of the chemical. Comments said lack of measured data presented a serious difficulty in meeting the proposed level ofaccuracy for quantities reported on question 3a. For the final rule, manufacturers may calculate the total loss for question 3a by finding the differences between the quantities theoretically manufactured, and quantities actually used or sold. For items 3b, 3c, and 3d, we have decided to allow respondents to simply tell us the accuracy of the quantities reported.The following difficulties were cited for reporting the destiny of losses: many times the amounts lost are very small,

on the order ofparts per million, and a 10 percent or 50percent difference would be insignificant or unmeasurable; routine methods for analyzing emission

or effluent amounts do not exist in most cases; and in some cases there are multiple sources ofloss that would make calculations extremely difficult. We have concluded that by allowing companies themselves to specify the accuracy ofthe figures, based on readily obtainable data, we will receive the estimates we need, without imposing unnecessary burdens. Companies are not required to conduct monitoring to comply with thisrule; they may answer this item by mass balance estimates.

The accuracy of reporting customer activities under item 9 of the proposed form received the greatest attention from commenters. Most commenters felt that quantities ofa chemical processed by individual customers inenclosed, open, or controlled release operations would be beyond theirknowledge in
most cases. Furthermore, the proposed item 9 asked for quantities of chemicals by customer use and process category in

a combined matrix. This simultaneous accounting forquantities would have required a customer-by-customer accounting, followed by sorting and aggregating quantities into 16 matrix boxes. In the view ofmost companies, this complicated accounting together with their lack ofknowledge of
customer processes would have resulted in frequent reporting ofquantities as "unknown."

We have changed the reporting of
customer activities in response to difficulties described in comments. The final form has two items, 9 and 11, to

cover customer activities. Item 9now asks for quantities by customer use within ±50percent accuracy. Commenters indicated that this could be done. Where respondents cannot report within ±50 percent, orwhere they have

a secrecy agreement with the customer, they may report "unknown." Item 11

now asks forthe respondent's estimate ofthe kinds ofprocesses generally used for the chemical.

In general, manufacturers should report information on their customers'

uses to the extent that this information is known. Manufacturers are not required to obtain additional information from customers for this rule.

C.ReportingWorker-Hours, Numberof Workers,andQuantities:Items 4-7

As a result ofcomments, EPA has simplified reporting ofworker-hours, number ofworkers, and quantities by process category under items 4-7. Only the workers directly assigned to the manufacturing, processing, and use of' the chemical should be counted. Maintenance workers should be counted only ifthey are directly assigned to and

are a regular part of a process.

When answering the items on workerhours ornumber ofworkers, respondents must (i) identify the process category (enclosed, controlled release,

or open) with which the worker spends the most time, and (ii) determine the number ofworkers involved with a given process category. For multiprocess operations, workers operating more than

one process category should be listed

### Federal Register / Vol. 47, No. 120 / Tuesday, June 22, 1982 / Rules and Regulations

only once-under the process category with which they work most of thetime. This should avoid double counting of workers.

Worker-hours need not be calculated from detailed production records, but may be based on design factors.That is, worker-hours may be estimated from the plant's production ofa given chemical and the design number of employees needed toachieve that production.

-

The final rule simplifies reporting by requiring the total number ofworkers involved in each process category, and deleting the proposed distinction between full andpart-time workers. The number ofworkers should include employee turnover, and will not necessarily correspond to worker-hours. Include all employees who workon a given chemical's production or processing, regardless ofthe length of time ofemployment.

Instructions have been clarified regarding items on the quantity ofa chemical that goes through each process category. Chemical production could involve a single process ora multiprocess operation, a split stream involving different processes, or two separate streams involving different processes (e.g., one stream might be for

a reagent grade chemical and another for a technical grade). The instructions discuss how to handle reporting in these differing circumstances.

D.Preparation and Usesof Manufacturer's Products: Items 7and8
The form has been revised to identify

more clearly the distinct activity of onsite product preparation (making a product containing the manufactured chemcial). Item7 in the final rule applies only to plant sites that both manufacture and process a chemical. Ifa manufacturer ofa listed chemical also produces a formulated mixture or other industrial or consumer product containing the chemical, he must report the chemical quantities, number of workers, and process categories in this question.

Item 8asks for the quantities ofthe substance incorporated into various use categories ofproducts produced by the manufacturer at the reporting site. This item alsoincorporates proposed question 12 on export of the chemical substance (as the chemical oras part of

a product).

Commenters thought we should differentiate between institutional and industrial uses to better judge exposures. We do not believe that this degree ofdifferentiation will contribute
to the evaluation ofa chemical without

more information on the manner ofuse ofthe chemical. Therefore, for the 

### purposes ofthis rule, "industrial" and "institutional" products are treated in the same manner.

Commenters said the definition of

consumerproducts should have the

same exemptions as listed in the Consumer Product SafetyAct (15 U.S.C. 2052(a)(1)(D)) (CPSA). We have not adopted this suggestion. Our purpose in citing CPSA is simplyto help differentiate between consumer and industrial products. Thus, the CPSA definition, without its exemptions, is included in the rule toguide manufacturers in categorizing their products.
E.CategorizingUses UnderItems8and 9


### Items 8 and 9 differentiate products intoarticles containing listed chemicals

versus products that are chemical substances ormixtures. Articles are further differentiated into those designed so that there is no release of the chemical during normal use, versus articles that may allow direct user contact with the chemical during normal

use. In evaluating exposure potential, chemicals in "articles with norelease" will be considered as having potential exposure onlyduring disposal or mishandling of the article.

One commenter said that fabrics with dyestuffs retained on them shouldbe considered as articles containing chemicals. We agree.These would generally be "articles with some release" sincethe chemical dyestuffs would be indirect contact with the user. F.CustomerUses:Items9.10, and11

Items 9 and 11 ask the manufacturer to estimate thequantities ofthe chemical that his customers incorporated into various categories of products, exported, consumed as reactant, and processed by various categories ofprocess. The manufacturer is to basehis estimates on his knowledge ofthemarket for the products and his customers' roles in that market.

Ifmanufacturers do not know how all quantities ofthe marketed chemical are used by customers, orifa use is subject to a secrecy agreement with the customer, the amount may bereported

as "unknown". Ifthemanufacturer reports that more than 20 percent ofthe total quantity manufactured and imported has unknown uses, in question 10he mustprovide the trade names under which he marketed the "unknown" amount. TheAgency, as discussed below, will use the trade

names for processor reporting, ifit becomes necessary forthat chemical. G.Follow-upReporting Nearly every industry comment requested that EPA eliminate the proposed requirement to submit customer listsfor purposes offollow-up reporting on customer data that are unknown tomanufacturers. Commenters cited several difficulties with the approach, including their own confidentiality concerns and the burden ofmaking up thelists when there are many customers. In addition, some pointed to thepotential burden for all concerned, including EPA, ofhaving follow-up proceed bymailing ofletters back end forth. This would be difficult, especially when manufacturers have customer addresses fordeliveries rather than addresses for technical contacts.

TheAgency sees merit in many ofthe comments on theproposed approach and is proposing a different one ina separate proposed rule elsewhere in this issue oftheFederal Register. The separate notice describes thenew proposal and discusses the comments already received on processor reporting. In general, under the new approach, the Agency would aggregate the manufacturers' reports on a chemical. If "unknown" uses are reported for more than 20 percent ofthe aggregate quantity manufactured and imported, the chemical willbe the subject offollow-up reporting by processors. Themarket

names forthe chemical willbe taken from the responses to question 10 ofthe manufacturers' reporting forms.These

names willbe published, and processors ofthe chemicals under these names will report about them. This approach is based on commenters' suggestions that EPA should specify criteria that would triggerfollow-up reporting, and that EPA shouldpublish trade names on which processors must report inorder to protect the confidentiality ofchemical product composition.

H. TimeAllowed ToReport

For thefinal rule, we based the time allowed toreport on comments, changes inprovisions ofthe rule and form, and the significantly decreased number of chemicals subject to reporting. From available data, we estimate the average and median number ofreports fora manufacturing site now to be 2.8 and 2, respectively. The maximum number of reports from any site is expected to be 35;the site with 35 reports has over$1 billion sales annually. Based on these data, four months from the effective date ofthe rule should allow enough time for reporting.

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## / Rules and Regulations

. ReportingPeriod

The Agency received comments saying thatrecords ofdata to be submitted under thisrule are often kept by a corporate fiscal year that does not coincide with the calendar year, and that it would be difficult for these companies to report by calendar year as originally proposed. To reduce this aspect ofthe reporting burden, EPA has changed the reporting period in the final rule. A company should report a chemical's production during the company's most recent complete corporate fiscal year as ofthe date the chemical is listed in § 712.30. This is the reporting period referred to in the discussion ofreporting requirements for manufacturers. Even though these reporting years may vary somewhat among manufacturers, the disparity will
not significantly affect the value ofthe data for purposes ofthis rule.

.PlantSiteReports

In response to comments that it would be burdensome for companies to aggregate data fromtheir plant sites before submitting it to EPA,the final rule now requires a form to be submitted for each plant site. Thus the address of the plant site must now be provided on the form, along with theDun and Bradstreet number for theplant site when thatnumber exists. The reporting
company may decide whether to have headquarters or individual sites complete forms, depending on which is

more convenient for the company. This approach also allows EPA togather data thatcan be compared tothe sitespecific data on the Inventory. This comparison will allow the Agency to

assess changes in the dimensions of potential exposure, and to consider potential local problems.

A question was raised in the
comments about whether a company manufacturing a chemical to order for another company should submit the form or let the buyer submit it. The

answer is that the actual manufacturer,
not the buyer, should submit the form.

K.Recordkeeping

Commenters expressed concern over the proposed requirement to maintain records that support information submitted toEPA. The proposed fiveyearretention period was said to be too long and too burdensome. The Agency agrees that this provision should be deleted. The records supporting reporting under this rule will be records that companies will retain as a matter of business. Companies should be alert to the possibility that they may be required
to report under this rule in the future 

### and consider or,ifnecessary, reconsider their recordkeeping practices in that light.
IV. Chemicals Subject tothe Rule

Thefinal ruleapplies to the approximately 250 chemical substances and three categories listed by CAS number in §712.30. Manufacturers and importers must report on these substances. (Analphabetized list ofthe chemicals can be requested from the Industry Assistance Office at the telephone number given at the beginning ofthis notice.) The three categories of chemicals need be considered onlyby persons who reported confidential chemical identities for the Inventory.

We wish to note that we will use future iterations of this rule to collect information on additional chemicals. One listofadditional chemicals is proposed forcomment separately in this issue ofthe Federal Register. We are also separately proposing thatcertain chemicals be placed automatically on the listand that reporting be immediately required onthose chemicals without proposal and comment.

Commenters wanted EPA to listthe

names ofall chemicals that mustbe reported forthis rule, and not to listany category names ofchemicals. The Agency does not intend that reports be submitted on all chemicals that fall withinthe listed categories. The purpose oflisting the categories is to require reporting on certain chemicals that are confidential on the TSCA Inventory. (Listing the CAS number of a confidential chemical would automatically divulge its identity.) Of the chemicals that fall within listed categories, a manufacturer must report only on the chemicals that he claimed confidential for the TSCA Inventory.
V. Other Issues
A. SmallManufacturers
Section 8(a)(3) ofTSCA requires the Administrator to consult with the Small Business Administration and then to prescribe, by rule, standards to determine who may qualify as a small manufacturer or processor. Such small businesses are then exempt from section 8(a) rule requirements. However, ifa chemical substance issubject to certain proposed orfinal actions by the Agency, EPAneed not apply the section 8 exemption forsmall businesses manufacturing or processing the chemical. Among the actions that could

remove the small business exemption

are proposed rules under section 4,5,or *

### 6 ofTSCA. Although several chemicals

in the list published today are subject to section 4 proposals, EPA has decided
not to require any reporting by small businesses. The additional data from those companies would not significantly influence the overall preliminary
assessments.

For thisrule, for a plant site toqualify

as small with respect to a listed chemical, a manufacturer or importer
must meet both ofthe following criteria:

i. Total annual sales taken together of all sites owned orcontrolled by the foreign or domestic parent company

were below $30 million for the reporting period.

As chemicals become subject to this rule in the future, the Agency will consider the need to adjust this dollar figure to-reflect inflation. Sales figures would bebased on activities at all ofthe plant sites ofthe reporting firm, its parent, and all subsidiaries owned or controlled by the parent company. The parent company owns orcontrols another company ifthe parent owns or controls 50 percent or more ofthe other company's voting stock, orother equity rights, orhas the power to control the management and policies ofthe other
company.

ii. Total production ofthe listed substance forthe reporting year was below 45,400 kilograms (100,000 pounds)
at the plant site.

The EPAhas consulted with the Small Business Administration in developing the exemption standard for the rule. The exemption criteria forthis rule have not changed from the proposal, except for the addition ofa factor to correct the sales cutofffor inflation.

B. Confidentiality

1. Certification. Some commenters noted that the effort they would have to spend to substantiate claims of confidentiality by answering the proposed substantiation questions would exceed that spent in answering the substantive questions presented in the form. After considering comments,

we have concluded that the method of substantiation outlined in the proposal

was overly burdensome and that a simplified method ofsubstantiation should be adopted forthis rule.

For the final rule, inorder to claim
any information on the form as confidential, the respondent must certify, as in the Inventory Reporting Regulations, that the claims of confidentiality are made ingood faith and that the four listed statements are true. This simplification will substantially reduce industry's expenditure oftime, money, and personnel.

### Federal Register / Vol. 47, No. 120 / Tuesday, June 22, 1982 / Rules and Regulations

The final reporting form has separate signatureblocks for confidentiality certification and for technical accuracy certification. This should alleviate the

concerns ofcommenters who said that

an importing subsidary may not be able
to certify to confidentiality claims for information supplied by a foreign parent. In this case, the foreign parent

can certify regarding confidentiality and theU.S. subsidiary can certify the
accuracy ofdata.

2.Releaseof datato thepublic. Industry and public interest groups expressed concern as to whether or not EPAplanned to publish aggregates of data from this rule or publish only those discrete data items that are not claimed confidential. Onepublic interest group preferred that the Agency release discrete data elements not claimed as confidential. They felt this would aid people in identifying local problems. Industry generally favored publishing aggregates ofthe data.

There are two purposes for releasing data received by the Agency:

i. To allow the phblic and the states to conduct local activities to identify and control risk situations, and

ii. To allow public comment on the aggregate data the Agency uses to make its decisions.

The first purpose seems best served bythe release ofdiscrete data items that have not been claimed confidential. However, comments indicated most of the reported data will be legitimately claimed to be confidential business Information. Therefore, the public would be likely to receive only incomplete data that had not been claimed confidential. Moreover, the release ofdiscrete nonconfidential data elements would limit the release ofthe aggregate data used in risk assessments; discrete nonconfidential data could be subtracted from the aggregate to reveal secret data.

Given these considerations, we have decided to release the following types of non-confidential data:

i. Identification ofa firm or plant site that manufactures or processes a chemical, except when this fact is confidential.

ii. Aggregate data on production, uses, and workers for each chemical.

It will be necessary for us to withhold

some data that have not been claimed confidential in order to protect confidential data within an aggregate. However, the Agency will determine its aggregation method ina manner that will allow as much data as possible to be released, but that will not allow confidential information tobe recognized by the public. By releasing aggregate data we will be able to share 

### information with thepublic, including the regulated industry.
VL Economic Impact

EPA estimates that chemical manufacturers will spend a maximum of $760,000 to report on the approximately 250 chemicals onthis rule.

Thefixed costsperplant site to comply with the rule are estimated at $480. This includes time to become familiar with thereporting requirements, and time todetermine which listed chemicals the plant site produces. Variable costs ofcompliance are estimated at an additional $420 per report that mustbe submitted.The variable costs include time to determine theinformation required, to determine whether the information should be claimed as confidential, and to complete theform and certification requirements. For the median company, therule will cost a maximum ofabout0.004 percent ofitsprofit. This is not a balance sheet loss,but a theoretical costbased on time the company will spend searching for data.

Thefixed and variable cost estimates

were based on the number ofhours that would be required to complete a form. EPA estimated an average of18hours for a site to become familiar with the rule, determine which chemicals to report on, and put together a final package for submittal to EPA. This figure could be lower or higher depending on how many forms are involved. An additional 16 hours were estimated fora site to complete each form.At an average of3reports per site, these estimates allow 66hours (18+(3 

## X 16)) for an average site's compliance.

TSCA Inventory data show that about 450 plant sites will submit a total of about 1,300 reports. Theplant sites represent about 330 companies, foran average ofabout 4 reports per company. VII. Rulemaking Record

The administrative record for thisrule (docketnumber OPTS 82004) contains thefollowing documents. All documents, including the index to thispublic record,

are available to the public in the OPTS Reading Room from8:00a.m. to 4:00 p.m. weekdays, Rm.E-107, 401 M St., SW., 

### Washington, DC 20460.This record includes basic information considered by the Agency in developing the final rule.The record includes the following information, which ismore specifically described in the TSCA Section 8(a) "Level A"Rulemaking Index to the Public Record:

(1)TheAdvance Notice ofProposed Rulemaking (OTS-82004a), published in the Federal Register ofJune 27, 1979(44 FR 37517). (2) Initial Report ofthe TSCA Interagency Testing Committee published in the Federal Register of October 12, 1977 (44 FR 55026).

(3) Written comments to the Advanced Notice ofProposed Rulemaking, numbered 1 through 33 (OPTS-82004a).

(4) Chronologically ordered preproposal comments, minutes, and released drafts, numbered I through 15.

(5) The proposed rule, "General Recordkeeping and Reporting Requirement: Preliminary Assessment Information" (OPTS-82004b), published in the Federal Register ofFebruary 29, 1960 (45 FR 13646).

(6) Petitionpresented toEPA on March 17, 1980 by the Chemical Manufacturers Association (CMA), and EPA's response, published in the Federal Register ofApril 28, 1980 (45FR 28173).

(7) Support documents, including: (a) "Chemical Source List" File, describing the sources and criteria used
to select the chemicals for this rule.

(b)High volume criterion, confidential file 20-8020030.

(c) Economic Impact Analysis and references.

(d) "Chemical Use List" and references to its file (OPTS-10001), published in the Federal Register ofJuly 25, 1978 (43FR 32222).

(e) Inter-agency survey by EPA, including all correspondence with other agencies in reference to this rule.

(f) Support documents forfinal sec. 8(a) "Level A"rule, Including inter-, Intra-agency, and outside correspondence in reference to this rule.

(8) All written comments to the Proposed Rule (OPTS-82004b).

(9)Telephone comments to khe Proposed Rule (OPTS-82004b).

(10) Notices concerning the proposed rule: corrections to the rulepublished in the Federal Register ofApril 7, 1980 (45 FR 23473), and April 18,1980 (45FR 26386), and a notice ofpublic meetings published in the Federal Register of April 28, 1980 (45 FR 28176). (11) Transcripts ofpublic meetings on the Section 8(a) "Level A" Rule.

(12)Miscellaneous agency comments, corrections, and correspondence relating
to the rule.

(13) Cross references to test rules developed under TSCA section 4(a).

(14) Any comment received from the Office ofManagement and Budget during its review ofthe rule regarding compliance with the Paperwork Reduction Act, orExecutive Order 12291.

(15) The document titled "Responses
to Individual Comments," which contains Agency responses to comments 

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on the proposedrule. This document is also considered to be incorporated by reference in this Federal Register notice ofthe final rule.

Additional documents may be added to the PublicRecord. Within 30 days of the date ofpublication, please notify us ofany errors or omissions in the Public Record. Address all correspondence to:

Document Control Officer (TS-793), Office ofPesticides and Toxic Substances, Environmental Protection Agency, 401 M St., SW., Washington, D.C. 20460.

VIII. Regulatory Assessment Requirements


### A. Executive Order12291

Under Executive Order 12291, EPA 

### must judge whether a regulation is "Major" and therefore subject to the requirement ofa Regulatory Impact Analysis. EPA has determined that this 

### regulation is not major because it does

not have an effect of$100 million or

more on the economy. It is expected to have a one-time maximum cost to 

### chemical manufacturers of about $760,000. It doesnot have a significant effect on competition, employment, investment, productivity, innovation, or ability ofU.S. based enterprises to 

### compete with foreign-based enterprises in domestic or export markets. This regulation was approved without comment by the Office ofManagement and Budget (OMB) as required by Executive Order 12291.

The information submitted under this rule will cost manufacturers approximately $3,000 per chemical. Itis difficult to put an absolute value on information, but the Agency has experienced costs of$10,000 per chemical for even fruitless searches of general reference sources forexposure information. The information to be reported, general as itis, will be ofmuch greater quality and thus reliability than any data otherwise available. When the information is used by EPA and other Federal agencies to setpriorities among chemicals, the rule will benefit the public primarily by identifying chemical hazards and thus allowing reduction of risks to health and the environment. The 

### rule will also save public and private time and expense by directing 

### regulatory attention away from many chemicals of lesser apparent risk. The potential value ofthe rule's information thus will be much greater than the cost of reporting.


### B.RegulatoryFlexibility Act

Since this rule was proposed before the effective date of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq., the Act's requirements do not apply. However, this rule is consistent with the Act's objectives in that it exempts small businesses fromreporting under this rule. EPA consulted with the Small Business Administration, Size Standards Division, in developing this exemption.

C.Paperwork ReductionAct

Information collection requirements contained in this regulation have been approved by the Office ofManagement and Budget (OMB) under the provisions ofthe Paperwork Reduction Act of1980, U.S.C. 3501 et seq., and have been assigned OMB control number 2000- 0420.

This rule requires manufacturers of about 250 chemicals to submit a twopage form describing their own and their customers' activities. The data to be submitted will permit EPA to estimate how much ofa chemical is made for

consumer versus industrial uses, how much is lostto the environment, the number ofworkers exposed during production and processing, and the degree ofthat exposure.

The rule provides the minimum information needed to assess the risks ofhuman and environmental exposure to chemicals in U.S. commerce. EPA has chosen 250 ofthe approximately 55,000 chemicals in U.S. commerce for reporting under this rule.

List ofSubjects in 40 CFR Part 712:
Chemicals, Environmental Protection. Reporting and recordkeeping requirements.

Dated: June 7,1982. Anne M. Gorsuch, Administrator.

Therefore, 40 CFR Chapter Iis amended by adding a new Part 712 to read as follows:

PART 712-CHEMICAL INFORMATION RULES Subpart A-General Provisions

Sec. 712.1 Scope and compliance. 712.3 Definitions. 712.5 Method ofidentification ofsubstances for reporting purposes. 712.7 " Report of readily obtainable information forSubparts Band C. 712.15 Confidentiality. Subpart B--Manufacturers ReportingPreliminary Assessment Information

712.20 Manufacturers and importers who must report. 712.25 Exempt manufacturers and importers. 712.28 Form and instructions. 712.30 Chemical lists and reportingperiods. Authority: Sec.8(a), Toxic Substances Control Act, Pub.L.94-469 (90 Stat.2003, 15 U.S.C. 2601 etseq.).
Subpart A-General Provisions §712.1 Scope and compliance.

This Part establishes procedures for chemical manufacturers and processors to report production, use, and exposurerelated information on listed chemical substances. Subpart A establishes requirements that apply to all reporting under this Part. Subparts B and C, respectively, cover manufacturers' and processors' reporting.
§712.3 Definitions.

The definitions in section 3 ofTSCA, 15 U.S.C. 2602, apply forthis Part. In addition, the following definitions apply:

(a) "Byproduct" means any chemical substance ormixture produced without

a separate commercial intent during the manufacture, processing, use, or disposal ofanother chemical substance

ormixture.

(b) "EPA"means the U.S. Environmental Protection Agency.

(c) "Import in bulk form" means to import a chemical substance (other than

as part ofa mixture or article) in any quantity, in cans, bottles, drums, barrels, packages, tanks, bags, or other containers used for purposes of transportation orcontainment, ifthe chemical substance has an end use or commercial purpose separate from the container.

(d) "Importer" means anyone who imports a chemical substance, including

a chemical substance as part of a mixture or article, into the customs territory ofthe U.S. and includes the
person liable for the payment ofany duties on the merchandise, or an authorized agent on his behalf. Importer also includes, as appropriate:

(1) The consignee. (2) The importer of record. (3)The actual owner if an actual owner's declaration and superseding bond has been filed in accordance with 19 CFR 141.20.

(4) The transferee, ifthe right to withdraw merchandise in a bonded warehouse has been transferred in accordance with Subpart Cof 19 CFR Part 144. Forthe purposes ofthis definition, the customs territory ofthe U.S. consists ofthe 50 states, Puerto Rico, and the District ofColumbia.

(e) "Impurity" means a chemical substance unintentionally present with another chemical substance ormixture.

(f) "Intermediate" means any chemical substance that is consumed, in whole orin part, in chemical reactions used for the intentional manufacture of

### Federal Register / Vol. 47, No. 120 / Tuesday, June 22, 1982 / Rules and Regulations

other chemical substances or mixtures,

or that is intentionally present for the
purpose ofaltering the rates ofsuch chemical reactions. (See also paragraph (j) ofthis section.)

(g) "Known to orreasonably ascertainable by" means all information in a person's possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, orknow, or could obtain without unreasonable burden.

(h) "Manufacture forcommercial purposes" means to import, produce, or manufacture with the purpose of obtaining an immediate or eventual commercial advantage for the manufacturer and includes, among other things, such "manufacture" ofany amount ofa chemical substance or mixture: (1)For commercial distribution, including for test marketing.

(2) For use by the manufacturer. including use for product research and development, oras an intermediate. Manufacture forcommercial purposes also applies to substances that are produced coincidentally during the manufacture, processing, use, or disposal of another substance or mixture, including byproducts and coproducts that are separated from that other substance or mixture, and impurities that remain in that substance

or mixture. Byproducts and impurities may not in themselves have commercial value. They are nonetheless produced for the purpose ofobtaining a commercial advantage since they are part ofthe manufacture ofa chemical produced for a commercial purpose.

(i) "Mixture" means any combination oftwo or more chemical substances if the combination does not occur in
nature and is not, in Whole orin part, the result ofa chemical reaction; except that "mixture" does include (A) any combination which occurs, in whole or in part, as a result ofa chemical reaction ifthe combination could have beea manufactured for commercial purposes without a chemical reaction at the time the chemical substances comprising the combination were combined, and ifall ofthe chemical substances comprising the combination are included in the EPA, TSCA Chemical Substance Inventory after the effective date ofthe premanufacture notification requirement under 40 CFR Part 720, and (B) hydrates ofa chemical substance orhydrated ions formed by association ofa chemical substance with water. The
term mixture includes alloys, inorganic glasses, ceramics, frits, and cements, including Portland cement.

(j) "Non-isolated intermediate" means any intermediate that is not intentionally removed from the equipment in which it ismanufactured, 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, but not including tanks or other vessels in which the substance is stored after its manufacture. (See also paragraph (f) of this section.) (k) "Owned or controlled by the parent company" means the parent

owns or controls 50 percent ormore of the other company's voting stock or other equity rights, orhas the power to control the management and policies of the other company.

(1) "Person" means any natural
person, firm, company, corporation, joint venture, partnership, sole proprietorship, association, or any other business entity, any State or political subdivision thereof, anymunicipality, anyinterstate body, and any department, agency, or instrumentality ofthe Federal government. (m) "Process for commercial purposes" means the preparation ofa chemical substance ormixture, after its manufacture, for distribution in

commerce with the purpose ofobtaining

an immediate or eventual commercial advantage forthe processor. Processing ofany amount of a chemical substance

or mixture is included. If a chemical or mixture containing impurities is processed for commercial purposes, then those impurities are also processed for commercial purposes.

(n) "Site" means a contiguous property unit. Property divided only by a public right-of-way shall be considered

one site. There may be more than one manufacturing plant on a single site.

(o) "Test marketing" means distributing in commerce a limited
amount ofa chemical substance or mixture, or article containing such substance ormixture, to a defined number ofpotential customers, during a predetermined testing period, to explore market capability prior tobroader distribution in commerce.

(p) "TSCA" means the Toxic Substances Control Act, 15 U.S.C. 2601
et seq. §712.5 Method ofIdentification of substances forreporting purposes.

(a)Reporton TSCA-reguloble quantities.Unless specifically otherwise required, respondents must report only about quantities ofa chemical that is defined as a chemical substance under TSCA section 3(2).

(b) Chemicals from natural sources.A manufacturer ofa chemical substance which is extracted from an ore, from oil, orfrom any other natural source must report only about the manufacturing steps for, and the uses of,that chemical,
not about production of the natural

source material orother crude precursors derived from the natural

source material.

For example, persons who manufacture a chemical substance such as "sweetened naphtha. 64741-87-3," but do notrefine the naphtha to produce "hexane, 110-54-3" would not report on hexane. Only the production of"hexane" as an isolated product must bereported-not previous production ofmore crude, complex substances such as naphtha from which hexane is extracted. Thus, persons who produce crude oil, ores, and othercrude natural materials, but do not carry them through further manufacturing steps that produce a listed chemical have noreporting responsibilities under this Part.Note, however,that any method ofextraction, refinement, orpurification ofa listed chemical substance is considered tobe manufacturing for the purposes ofthis rule.

(c) Chemicalsubstancesasmarketed. ThisPart requires reporting about chemical substances as they are marketed orused in practice. The following preparations ofa chemical substance must be reported as the substance itself,not as a mixture, since these preparations are regarded as the substance in practice.

(1)The chemical substance inaqueous solution.

(2] The chemical substance containing

an additive (such as a stabilizer or other chemical) to maintain the integrity or physical form ofthe substance.

(3) The chemical substance in any grade ofpurity. §712.7 Report of readily obtainable Information forSubparts Band C.

TSCA section 8(a) authorizes EPA to require persons to report information that is known to orreasonably ascertainable by them.For purposes of Subparts B and C, however, a lesser standard applies. Companies must report information that is readily obtainable by management and supervisory employees responsible for manufacturing, processing, distributing, technical services, and marketing. Extensive file searches are not required.
§712.15 Confidentiality.

(a) Any person submitting information under this Part may assert business confidentiality claims for the information as described in the pertinent reporting form and its instructions. Any information covered by a claim will be disclosed by EPA only as provided in the procedures setforth at 40 CFR Part 2. 

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### 27000 Federal Register / Vol. 47, No. 120 / Tuesday,,June 22, 1982 / Rules and Regulations

(b) Persons must certify to the validity ofa claim ofconfidentiality they make for information reported under this Part,

as specified on the reporting form.

(c) Ifno claim accompanies the information at the time itis submitted to EPA orifcertification as to the claim is
not made on the reporting form, EPA
may place the information in an open file available to the public without further notice to the submitter.
Subpart B-Manufacturers Reporting-Preliminary Assessment Information
§712.20 Manufacturers and Importers who must report.

Except as described in § 712.25, at the time a chemical substance is listed in § 712.30, the following persons must submit the "Manufacturer's ReportPreliminary Assessment Information" (as described in § 712.28) for each plant site at which they manufactured or imported the chemical substance during the reporting period specified in §712.30:

(a) Persons who manufactured one or

more of the chemical substances listed in §712.30 for commercial purposes.

(b)Persons who imported in bulk form

one or more ofthe chemical substances listed in §712.30 for'commercial
purposes. §712.25 Exempt manufacturers and Importers.

(a) Persons who manufactured or imported the chemical substance during
the reporting period, solely for purposes of scientific experimentation, analysis,

or research, including research or analysis for product development, are
not subject to reporting under § 712.20.

(b) Persons who, during the reporting period, manufactured or imported fewer
than 500 kilograms (1100 pounds) ofthe chemical substance at a single plant site

are not subject to reporting for that site under § 712.20.

(c) Persons who qualify as small manufacturers or importers in respect to

a specific chemical substance listed in § 712.30 are exempt. However, this exemption does not apply with respect
to any chemical in § 712.30 designated by an asterisk. A manufacturer is qualified as small and is exempt from submitting a report under this Subpart for a chemical substance manufactured

at a particular plant site ifboth ofthe following criteria are met:

(1) Total annual sales taken together ofall sites owned or controlled by the foreign or domestic parent company

were below $30 million for the reporting period;

(2) Total production ofthe listed substance for the reporting period was below 45,000 kilograms (100,000 pounds)
at the plant site.



### (d)Persons are not subject to reporting under § 712.20 ifthey manufactured or imported the chemical substance during the reporting period only in the following forms:

(1)As a byproduct that was not used

or sold or thatwas formed as described in40 CFR 710.4(d) (3)through (7).

(2) As a non-isolated interimediate. (3) As an impurity.
§712.28 Form and Instructions.

(a) Manufacturers and importers subject to this Subpart must submit a single EPA Form No. 7710-35, "Manufacturer's Report-Preliminary Assessment Information," for each plant site manufacturing orimporting a chemical substance listed in §712.30.

(b) Reporting companies may submit their reports through individual plant sites or company headquarters as they choose. A separate formmust be submitted for each plant site manufacturing the chemical substance.

(c) Forms must be sent to: Document Control Officer, Office ofPesticides and Toxic Substances, Environmental Protection Agency, P.O. Box 2080, Rockville, MD 20852.

(d)Instructions and a facsimile ofthe form are as follows:

BILLING CODE 6560-50-M