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Citation: 51 Fed. Reg. 21437 1986

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## Thursday June 12, 1986



# Part II



# Environmental Protection Agency

40 CFR Part 710 Partial Updating of TSCA Inventory DataBase; Production and Site Reports; Final Rule

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ENVIRONMENTAL PROTECTION
'AGENCY

40 CFR Part 710

I OPTS-82015A; FRL-2973-31

Partial Updating ofTSCA Inventory Data Base; Production and Site Reports
AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule.

SUMMARY: This rule, promulgated under the authority of section 8(a) ofthe Toxic Substances Control Act (TSCA), requires manufacturers and importers of certain chemical substances included on the TSCA Chemical Substances Inventory to report current data on the production volume, plant site, and sitelimited status ofthe-substances. After the initial reporting, recurring reporting will be required every 4 years for as long as this rule is in effect. Promulgation ofthis rule does not affect the status ofa chemical substance listed

on the Inventory. DATES: This rule shall be promulgated for purposes ofjudicial review under section 19 ofTSCA at 1 p.m. eastern daylight time on June 26,1986. This rule is effective on August 25, 1986. FOR FURTHER INFORMATION CONTACT: Edward A. Klein, Director, TSCA Assistance Office (TS-799), Office of Toxic Substances, Environmental Protection Agency, Rm. E-543,401 M St., SW., Washington, DC 20460, Toll free: (800-424-9065), In Washington, DC: (554-1404). Outside the U.S.A.: (Operator-202-554-1404).
SUPPLEMENTARY INFORMATION:

I. Authority

This rule ispromulgated under section 8(a) of TSCA, which provides the Administrator ofEPA the authority to require, by rule, manufacturers, importers, arid processors ofchemical substances to submit such information

as the Administrator may reasonably require. Failure tocomply fully with any provision ofthis rule is a violation of section 15 ofTSCA and will subject the violator to the penalties ofTSCA sections 16 and 17.

II. Summary ofthe Rule

This rule requires manufacturers and importers to report current data ofn the production volume, plant site, ahd sitelimited status (i.e., whether a chemical substance is manufactured and processed only within a plant site and is not distributed for commercial purposes
as a substance or as part of a mixture or 

### article outside the plant site) for certain chemical substances included on the TSCA Chemical Substances Inventory. For the purposes ofthis rule and preamble, the term "manufacturer" includes importer,unless otherwise specified. A person is considered to be a manufacturer subject to this rule ifthat person has manufactured or imported a reportable substance in theUnited States at any time during that person's most recent complete corporate fiscal year preceding the effective date ofa relevant reporting period specified in this rule.

This rule requires both initial and recurring reporting. During the initial reporting period, every manufacturer of

a chemical substance covered by this rule who produces over10,000 pounds (4,540 kilograms) ofa reportable substance at a plant site willbe required to report separately on every such substance. Low-volume substances, i.e., substances with an annual site-specific production volume (ortotal amount imported) ofless than 10,000 pounds, are excluded from this rule. After the initial reporting period, the same type of reporting willbe required every 4 years foras long as this rule is in effect.

The substances covered by thisrule include those that were initially reported forthe Inventory, as well as substances added to the Inventory following TSCA section 5(a) premanufacture notification (PMN) review and the Agency's receipt ofa notice ofcommencement ofmanufacture

orimport. Fourcategories ofsubstances, though on the Inventory, are generally excluded from this rule.These excluded substances are those that are identified

as polymers, inorganic substances, microorganisms, and naturally occurring chemical substances as described under 

### §710.4(b) ofthe Inventory Reporting Regulations. However,no substance, except one which is naturally occurring, is excluded from this rule ifthat substance is the subject ofan order issued pursuant toTSCA section 5(e) or. 5(f), or is the subject ofa ruleproposed

orpromulgated under TSCA section 4, 5(a)(2), 5(b)(4), or 6, or is the subject of reliefgranted under a civil action under section 5or7 ofTSCA.

In addition to the proposed exclusions ofsubstances, two categories ofpersons
are exempt from certain reporting and recordkeeping requirements: Small manufacturers and persons manufacturing substances in limited circumstances. The small manufacturer exemption, however,does not apply if the substance to be reported by the' small manufacturer is the subject of an order issued pursuant to TSCA section 5(e),'or is the subject ofa rule ;* promulgated under TSCA section 4, 5(b)(4). or6, or is the subject of relief granted under a civil action under section 5or 7ofTSCA.

The information reported under this ruleincludes chemical identity, plant site, annual production volume, and sitelimited status ofa reportable substance. For each submission, EPA also requires thename, address, and telephone number ofa person who can answer technical questions related to the submission.Persons subject to this rule

are required to maintain records that support the information in their submissions. Suchrecords are to be kept for 4years beginning with the effective date ofeach reporting period.

III. Background

Inthe Federal Register ofMarch 12, 1985 (50 FR 9944), EPA published a proposed rule for reporting ofcurrent data on theproduction volume, plant site, and site-limited statusof certain chemical substances included on the TSCA Chemical Substances Inventory. EPA indicated inthe proposal that it needs this information to update a critical portion of the TSCA Inventory data base which is used to support a number ofTSCA activities. A 60-day public comment period followed the publication oftheproposed rule:

This notice discusses themajor comments, modifies certain provisions ofthe proposed rule, and promulgates the final rule under the authority of section 8(a) ofTSCA. This rule is promulgated as an amendment to 40 CFR Part 710which currently contains the Inventory Reporting Regulations of 1977. This amendment formally designates existing §§710.1 through 710.8 as Subpart A and adds new SubpartB.

IV. Provisions ofthe Final Rule

A. SubstancesCoveredby theRule

Reportable substances under this rule

are those that are listed in the Agency's Master Inventory File as ofthe time of reporting and that are not specifically excluded from-this rule. Substances which were originally excluded from the initial Inventory under 40 CFR 710.2 are therefore not reportable under this rule.

As an aid to submitters under this rule,EPA is publishing a 1985 edition of the TSCA Chemical Substances Inventory which supersedes theInitial Inventory published In 1979and the supplements to the Initial Inventory. This reissued Inventory covers over

3,000 substances, including 6,000 substances which have been added since the last publication in 1982. Since

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the printed Inventory can never be as complete as the Agency's Master Inventory File (which also contains specific identities for confidential substances), the Master Inventory File is, therefore, the only source which can conclusively determine whether a substance in question is on the Inventory. Manufacturers who may be subject to therequirements of thisrule

are urged to first use the printed Inventory for reporting purposes, especially for substances with ' nonconfidential identities, before requesting EPA to perform a search of the Master Inventory File. Procedures for requesting a search of the Master Inventory File are discussed in the instruction booklet entitled "Instructions for Reporting for the Partial Updating of the TSCA Chemical Inventory Data Base." A copy of this instruction booklet

can be obtained by contacting the Agency at the address listed in §710.39 ofthis rule.

Since EPA continually adds to the Master Inventory File substances that have undergone PMN review and that

are subsequently reported as manufactured orimported, the Agency
may publish supplements to the Inventory from time to time covering additions to the Master Inventory File since a previous publication. Substances added to the Master Inventory File after the start ofa reporting period become reportable in the next reporting period, unless otherwise excluded from this rule.

B. SubstancesExcludedFromtheRule

Four categories of substances, though included on the Inventory, are generally excluded from the reporting and. recordkeeping requirements ofthis rule. These categories are polymers, inorganics, microorganisms, and naturally occurring chemical substances. However, ifa polymer, an inorganic substance, or a microorganism is the subject ofan order issued pursuant to TSCA section 5(e) or 5(f), oris the subject ofa rule proposed or promulgated under TSCA section 4, 5(a)(2), 5(b)(4), or 6, or is the subject of relief granted under a civil action under TSCA section 5 or 7, that substance is
not excluded from the rule.

To assist manufacturers subject to this rule to quickly.identify an excluded substance, EPA has labeled with a special "XU".flag in the 1985 edition of the printed Inventory most ofthe substances that are excluded from this rule. Where a flagis found,.: manufacturers may rely on itas a signal that labelled substance is not subject to reporting. Where no flag is found and a substance may appear to fall within an excluded category, manufacturers should consult EPA. This is a consequence oftechnical difficulties with the application offlags by computer.

The four excluded categories are discribed below:

1. Polymers.For the purposes of this rule, a polymer is identified by the
presence of any one (ormore) of the word fragments "*polym*", "*alkyd", or "*oxylated" in the Chemical Abstracts Service (CAS) Index or Preferred Nomenclature ofa particular substance, where the asterisk (*)indicates that any set ofcharacters may precede, or follow, the character string defined. The CAS Index or Preferred Nomenclature can be easily obtained from the printed Inventory's "Chemical Substances Identities" section.

Polymers which are UVCB (i.e., chemical substances ofunknown or variable composition, complex reaction products, and biological materials]} substances, which do not contain one of the aforementioned character strings,

can be identified in the hierarchy of subset headings in the printed Inventory's UVCB Index section. These UVCB subset headings are as follows: siloxanes and silicones, silsesquioxanes, proteins (albumin, casein, gelatin, gluten, hemoglobin), enzymes, polysaccharides (starch, cellulose, gums), rubber, or lignin. In general, all individual substances listed under any of the above UVCB subset headings are considered polymers and are therefore excluded from this rule. However, polymers which have been hydrolyzed, depolymerized, or chemically modified
to the extent that the final products are

no longer'polymeric (e.g., a protein Which is completely hydrolyzed into amino acids) are reportable.

EPA has labeled with an "XU" flag in the 1985 edition ofthe Inventory all of those polymers which contain one ofthe aforementioned character strings. UVCB biopolymers, except for those that contain a character string,orpolymer code, are generally not flagged. Therefore, users ofthe printed Inventory should be aware that substances other than those labeled with the "XU" flag
may also be excluded from this rule.

EPA believes that the coverage for polymers for the purposes ofthis rule is sufficiently broad to include virtually all those substances that aregenerally considered as polymers.

2..Inorganics. For the purposes of this rule, inorganic substances are those that do not contain a carbon atom, or contain carbon only in the form ofcarbonato [= C03], cyano 

### [-CNI; isocyano [-NC], cyanato [-OCNI, or isocyanato [-NCO ] groups, or the chalcogen analogues of these groups.

In the 1985 edition of the Inventory, "XU" flags are applied to all inorganic substances that have molecular formulas which do not contain the element carbon. UVCB inorganics with

no molecular formulas or inorganics containing carbon are not flagged on the Inventory, although they are considered inorganics and notreportable under this rule.

3.Microorganisms. For the purposes of this rule, this category includes bacteria, eimeria, fungi, and yeasts which are easily identifiable in the hierarchy ofUVCB subset headings and

are also identified on the Inventory by theircorresponding CAS Preferred Names which are usually standard

names for the species. Products of microorganisms are, however, reportable unless otherwise excluded. In the 1985 edition ofthe Inventory, "XU" label flags are applied to all substances listed under one ofthese three UVCB subset headings.

4. Naturallyoccurringchemical substances.Chemical substances, as described in.§ 710.4(b) of the Inventory Reporting Regulations (40 CFRPart 710) of 1977, are considered "naturally occurring" and are not reportable under this rule. However, persons who produce a substance in a manner other than as described in §710.4(b) are required to report unless otherwise excluded.

This exclusion covers chemical substances which are naturally., occurring and which are unprocessed or processed only by manual, mechnical, or gravitational means, by dissolution in water,by flotation, or by heating solely

to remove water or which are extracted from air by any means. Examples of stkch substances include raw agricultural commodities, water, air, natural gas, crude oil, minerals, ores, and rocks.

Since whether a substance is considered as "naturally occurring" depends on the manner in which it is produced, it is impossible to label such substances with the "XU" flags because "naturally occurring" substances are not included on the Inventory.

C.PersonsSubjectto theRule

Except for those persons desbribed in unit IV.D below, a person is a manufacturer subjectto this rule ifthat
person has manufactured or imported for commercial purposes 10,000pounds

or more of a reportable substance at a particular site at any time during that person's most recent complete corporate fiscal year immediately preceding the 21439

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effective dateof the rule or the start of any recurring reporting period.

D.Persons Exemptfrom the Rule
Two categories ofpersons are exempt frbi the'reporting and .recordkeeping requirements of this rule,provided that they qualify forone ofthe exemptions during areporting period. Since aperson who qualifies foran exemption during
one reporting period may no longer qualify during the next reporting period, each person who may be.subject to this rule must determine the person's exemption status during each succeeding reporting period.

1.Smallmanufacturers.Persons qualify as small manufacturers under this rule if,at the time of reporting, they meet one ofthe two standards specified in the TSCA section 8(a) Small Manufacturer Exemption Rule (40 CFR 704.5(d)) which was published in the Federal Register ofNovember 16, 1984 (49FR 45425). However,no person is considered asmall manufacturer forthe purposes of reporting achemical substance that is the subject ofan order issued pursuant to TSCA section5(e), or is the subject of arule proposed or promulgated under TSCA section 4,or 5(b](4), or 6,or is the subject of relief granted under acivil action under TSCA section 5or 7.Such persons must comply with the reporting and recordkeeping requirements under this rule for that particular substance.

.

2.Persons manufacturing substances inlimitedcircumstances.Persons who manufacture reportable substances either in limited ways or through coincidental manufacture are exempt from the requirements ofthis rule for those substances. Therefore, persons who manufacture or import substances solely in small quantities for research and development or persons who import substances as part of articles,are exempt from this rulefor those activities.Furthermore, persons who manufacture substances as impurities, byproducts,or in amanner incidental to another operation or upon end use of another substance or mixture, as " described under §720.30 (g)and (h)of the Premanufacture Notification Rule of 1983, are also exempt from the requirements ofthis rule for those substances.
E.Low-Volume Threshold

For the purposes ofthis rule, alowvolume reporting threshold is established to exempt from reporting ,those substances that are produced at low volumes. Ifaperson's site-specific annual production volume for a reportable substance isbelow 10,000 pounds during the person's most recent complete corporate fiscal year before a reporting period, no reporting will be required for that substance for that period. In the case of importers, the • measurable volume is the total-amountof a substance imported during that year by eachsite which contains an operating unit responsible for the import. Thus a company which allows each plant to conduct its own import' operations would make the determination for each such plant; a company which handles imports through •its corporate headquarters would make the determination for all imports handled through the headquarters on an aggregate basis. Similarly, reports would be made by the site which actually conducts the import operation-either the specific plant orthe corporate headquarters. If a substance's site-. specific annual production volume or total amount annually imported increases to 10,000 pounds or more during the fiscalyear preceding a subsequent reporting period, the person would be required to comply with the reporting requirements of this rule for that substance at that site.

F When toReport

Current data, as described under unit
IV.G below, must be submitted for each reportable substance at each plant site

once every 4 years. For each round of reporting, submitters will have 120 calendar days to submit a report. Therefore, the first reporting period will
commence on the effective date ofthis rule and will end 120 days after the effective date. Recurring reporting will take place on the fourth anniversary of the effective date and every 4 years thereafter. EPA plans to publish in the Federal Registera brief reminder announcement 2 months prior to the 'beginning date of each recurring reporting period.

G. WhattoReport

Persons who are subject to this rule
are required to report by completing original numbered copies ofthe reporting form designated in §710.39 of the rule, or by submitting the information in a computer tape. No other types of submissions willbe acceptable. Detailed instructions for filling out the reporting form as well as specifications for submitting computer tape are discussed in the reporting instruction booklet. Persons who report via computer tape must follow the specifications discussed in the instruction booklet. Otherwise, the tape, cannot be processed, will be rejected,. and must be resubmitted.

To further simplify reporting procedures, EPA has combined the two previously proposed reporting forms into

one form. Submitters, however, must not mix on one form information for substances with confidential chemical identities and information for those with nonconfidential chemical identities. Parts f,II, and III of the reporting form include :the certification to be signed by the submitter and other basic submitter information. The extent to which Part IV ofthe form is completed will depend on the number of chemical substances reported on that form. Copies ofthe reporting forms can be obtained by contacting EPA at the address listed in §710.39 of this rule.

The information requirements for this rule are discussed below.

1.Chemicalidentity.For each chemical substance covered by this rule,

a submitter is required to provide certain specific information which will enable the Agency to identify quickly and uniquely that substance.Where known, such information must include the CAS Registry Number and a chemical name that is not a trade name. For most ofthe nonconfidential substances, the corresponding CAS Registry Number can be easily obtained from the 1985 edition ofthe Inventory. If the identity ofthe substance is claimed

as confidential and no CAS Registry Number has been assigned to that substance, a submitter should provide a chemical name and an EPA-designated Accession Number for that substance. Each substance with a confidential identity has been assigned an Accession Number. Accession Numbers for confidential substances are listed in the generic names section ofthe printed Inventory. Ifa person does not know whether a substance is covered by one ofthe generic names, the person should contact EPA by following the procedures described in the aforementioned instruction booklet to determine whether the substance in question is reportable.

Other identifying numbers, i.e., PMN Case Number, original Inventory Reporting Form Number, Bona Fide Document Control Number, orTest Market Exemption Application Case Number, should-be used only if a submitter cannot identify a particular substance by either its corresponding CAS Registry Number or EPA Accession Number,

2.Plant site. Manufacturers are required to report by specific plant site

name and street address. Corporate headquarters, business, or Post Office Boxaddresses are not acceptable for reporting. However, if a corporation has

a number of plantsites and wishes to have the corporate headquarters

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coordinate the submission ofreports, it may do so as long as information for different plant sites isreported on separate reporting forms.

With regard to importers, the definition under §7-10.2(l) of the Inventory Reporting-Regulations applies. Therefore, an importer means ". * *


### any person who imports a chemical substance, including a chemical substance as part ofa mixture or article, into the customs territory ofthe United States," and includes .**. the person 

### primarily liable forthe payment ofany duties on the merchandise * * i". Forthe 

### purposes ofthis rule, as discussed in Unit IV.E. above, certain importers must report by the United States headquarters or similar central office. However, ifa plant Site imports a substance directly from a foreign supplier and is "primarily liable forthe payment ofany duties".on that substance, theplant is-then the importer ofthat substance. In that case, the imported substance must be reported directly by that plant site. This approach allows companies.to'report consistent with the conduct oftheir importing.

Each submitter is also required to provide a Dun &Bradstreet Number for each site reported under this rule.

3.Manufacturer/importer. Every submitter is required to indicate whether that person is a manufacturer and/or an importer for each ofthe substances reported foreach site,

4. Site-limitedstatus.Manufacturers

arerequired to indicate whether a chemical substance manufactured at a plant site is distributed forcommercial purposes outside that Site, as a , substance or as part ofa mixture or an article. Imported substances cannot be site-limited.

5.Productionvolume. Respondents to this rule mustreport the plaitsite production volume (or'total quantity imported) ofeach substance forwhich reporting is required. Quantities must be reported in pounds. Reporting mustbe accurate to the extent that the information is known to or reasonably ascertainable by the submitter, or to two significant figures. Production volume information reported within ±10 percent ofthe actual value willbe acceptable for purposes ofthis rule. Manufacturers are required to report the annual production volume of each reportable substance at each plant site
at which it is produced. Importers may report volume by plant site or as the total quantity imported by the company.

6. Technicalcontact. For each report submitted.undeir thig rule, a submitter is. required to identify the name, address, and telephone number.of an individual who can answer questions concerning the information on the reporting form..



### H.Confidentiality

1.Assertingclaims.While information submitted under this rule can generally be claimed as confidential, EPA strongly
encourages respondents to this rule to carefully consider the necessity of asserting such claims. As provided by section 14 ofTSCA, claims of confidentiality cfin be asserted only if release ofthe information would reveal
company trade secrets or other confidential commercial or financial information. Furthermore, claims of confidentiality must be asserted at the time information is submitted to EPA in the manner specified in the rule and reporting instructions. EPA's procedures for processing and reviewing confidentiality claims are set forth at 40 CFR Part 2, Subpart B.

To claim information as confidential,

a submitter is required to check the appropriate: box and sign the certification statement on the reporting form. Ifa submitter fails.to do so, EPA
may release the information to the public without further notice to the submitter. By signing the certification
statement the submitter certifies that its claims ofconfidentiality are made in good faith and that the statements on the back ofthe reporting form are true for each claim. Procedures forclaiming

as confidential information submitted by computer tape are contained in the instruction booklet.

2. Chemicalidentity.Ifa submitter wishes to claim the specific identity of a reportable substance as confidential business information, the submitter must report on the form (not by'computer tape) and must check the "confidential" box for chemical identity under Column IV d ofthe reporting form and provide' the required substantiation by: answering the questions in § 710.38(c)(2) ofthis rule. A submitter, however, may not assert a claim ofconfidentiality for the identity ofa substance ifsuch identity is not already held confidential

on the Inventory as ofthe time ofthe report. Foreach ofthe recurring reporting periods under this rile, a submitter is required to resubstantiate each claim of confidentiality even ifthe circumstances with regard to that claim have not changed since the last report.

If a manufacturer reports'information under this rule for a chemical substance whose identity is held confidential on the Inventory and the manufacturer does
not claim the chemical identity confidential, EPAwill consider the identity ofthat substance no longer confidential for the purposes o.f the Inventory and may therefore disclose the identity of that substance. EPA strongly encourages industry to reconsider the necessity ofretaining those claims. If a submitter decides not
to assert again a claim of confidentiality for the identity ofa :substance which is

on the Inventory, that 'suibn'itterwill simply submit the required data under thisrule for that substance, and Will check the "nonconfidential" box for chemical identity on the reporting form.

Submitters are required to segregate information on substances with confidential identities from the information on those with nonconfidential identities by using separate forms for each.

I. RecordkeepingRequirements

Persons subject to this rule are required to maintain records for a period of4 years beginning with the effective date ofa reporting period As long as the records are maintained in a manner consistent with normal business practice, each submitter may determine the exact format in.which the records

are to be kept. The records that are required include those that show the production volume, plant site, and sitelimited status ofeach of the-substances reported. Ifa substance is not reported because its site-specific annual production is less than 10.000 pounds, only the site-specific production records for that substance need to be kept. Persons who qualify as exempt small manufacturers are not required to keep records.

V. Discussion ofMajor Comments

EPA received comments from 37- organizations. Although many of the
comments were received after the closing date ofthe comment period, the Agency fully considered all of'them in promulgating the final rule. While almost all ofthe commenters agreed that EPAneeds current data to update'the Inventory data base, many presented suggestions regarding specific provisions ofthe proposed rule. Some
commenters requested that EPA grant

more chemical exclusions under this rule. One commenter, however, argued that the proposed chemical exclusions

are notjustified and urged the Agency to broaden the scope of the update'by including all Inventory.substances under the rule.

This unit discusses the major
comments that have the greatest impact

on the rule, and gives EPA's response for each of'these cOmmients. EPA has also classified into'generi6c aiegories !Il
comments received and summarized the Agency's response to these comments. This summary, together-with copies of 

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the public comments, is included in the public record for this rulemaking Idocket number OPTS- 82015Aj. Therefore, EPA's response to comments that are not specifically discussed in this unit

can be found in therulemaking record.
A.ReportingActualProductionVolume

Comments.Eighteen commenters objected to the proposed requirement that production volume information be reported in pounds, rather than in ranges as used in reporting for the 1977 Inefitory.These commenters urged EPA to reconsider its position toward precise production data for the following

reasons:

First, the commenters noted that reporting ofprecise production volume would significantly increase thenumber ofconfidentiality claims on production information. They pointed out that such

a reporting requirement would directly contradict EPA'sexpressed desire that industry exercise restraint to reduce the number ofconfidentiality claims for data to be submitted under this rule.

Second, some commenters argued that ifthe primary purpose ofthe Inventory data base is to provide basic information forpriority setting or .chemical screening, as EPA indicated in the preamble to the proposed rule, the need forprecise production data for these purposes is not fully justified because these uses ofthe data would not require such a level ofaccuracy.

Third, certain commenters pointed out that it would be technically difficult to report precise production data for certain types ofsubstances. For example, precise production data would be difficult tocalculate foringredients in formulated products or mixtures, especially for imported mixtures. They, maintained that a submitter would have to review each product or mixture to determine thepercentage composition of each oftheingredients. From the percentage composition and total production volume, the production volume ofeach ingredient would be calculated.

Fourth, some commenters noted that 'precise production data would, in some cases, create even more uncertainty than production ranges because a particular annual production may be atypical. Furthermore, initial precision could degrade substantially over time. Reporting in exact figures would create, at best, a false precision.They also maintained that it is inconsistent for EPA to require such'a degree of accuracy when the low-volume threshold provision ofthis rule Would allow production data up to 10,000 pounds to be excluded entirely. Almost all ofthe 18 commenters agreed that the production ranges used for the 1977 Inventory reporting are too 

### broad, and recommended that EPA consider using ranges that are narrower. As a minimum, they suggested that EPA allow reporting ofpreciseproduction data to one or two significant figures or rounding the figures to the nearest 10,000 pounds.

. EPA 'W response.EPA is aware that requiring precise production data under this rule could result inmore frequent claims ofconfidentiality for production data than were asserted under the original Inventory rule. However, the

same result is likely ifproduction data

were required to be reported under this rule in ranges thatare narrower than those required under the oriqinal Inventory. Ifbroad ranges were required, the data would be of diminished use to EPA. Therefore, EPA believes that the advantages ofrequiring production data tobe reported in specific numbers will far outweigh the possible' disadvantage ofincreased confidentiality claims. It should be noted that EPAwill closely monitor claims ofconfidentiality asserted under this rule.

EPA disagrees with the commenters' contention thatprecise production data

are notjustified under this rule. In the preamble to the proposed rule, EPA stated that the Agency "needs production data to set priorities for further investigation, to perform firstlevel screening ofchemical substances for testing under TSCA section 4, to estimate, along with other data, the potential for human and environmental
exposure to specific substances, to support the implementation ofvarious TSCA regulations, and to perform economic impact analyses for potential TSCA regulations." These uses will require data that are reasonably
accurate. The ranges used for reporting the 1977 production data forthe original Inventory were so broad thatthe resulting uncertainty became unacceptable in many applications including priority setting.

Many commenters perceived that they would be required to count every pound ofa chemical substance produced at a plant site. This is not the intent of the Agency. In fact, the preamble to the proposed rule clearly states that "a submitter should provide the best available,information, i.e., production figures normally maintained at a plant site for business purposes and known to,

orreasonably:ascertainable by, a submitter:* **'Some commenters. urged EPA topermit the reporting of production data to two significant. figures. EPA agrees with this comment 

### andhas included such a requirement in the final rule.

Regarding the-technical difficulty in obtaining production figures for ingredients in formulated products or mixtures, EPA believes that this difficulty is overstated. Regardless of whether production volume is reported in ranges orin actual figures, a submitter will have to do almost the

same amount of work to calculate the production volume for each ofthe ingredients in a product or a mixture. Furthermore, the provision oftwo significant figures will sufficiently lessen theburden associated with that calculation.

EPA recognizes that actual production data, like production ranges, will inevitably degrade over time. Actual figures, however, are initially more accurate than ranges. Over a period of time, theinitial uncertainty associated with production ranges willbe compounded by degradation. thus making therianges less desirable.

EPA disagrees with the contention that there is an inconsistency between requiring preciseproduction data to be reported and exempting from reporting those substances with an annual sitespecific production volume of less than 10,000pounds. EPAestablished 'the lowvolume threshold for this rule to better focus its information collection effort on substances representing a greater potential exposure concern and to provide certain reporting relieffor those who manufacture only a small amount ofa reportable substance. However, if a company's production volume ofa reportable substance increases to 10,000 pounds annually at a particular site, reporting willbe required. This -, provision bears no relationship to the level ofaccuracy at which the data are reported.
B.RecurringReportingand Reportable Events

Inthe March 12 Federal Register notice, EPA proposed that recurring reporting be required every 2 years ifa reportable event has occurred. Repo'rtable eventsgenerally reflected what EPAconsidered assignificant changes inproduction volume or sitelimited status ofa reportable substance. In addition to the proposed approach, twopossible alternatives were : discussed in the preamble. One ofthese two alternatives would require automatic reporting periodically on all reportable substances, regardless of whether a reportable event has: occurred.

Comments.Seventeen commenters addressed the issue ofrecurring

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reporting in their comments on the proposed rule. While all ofthese commenters agreed that some kind-of recurring reporting isnecessary to maintain a current data base, they all. disagreed with EPA's proposed approach. Major•

### points oftheir
comments are summarized below:

First, many commenters contended that recurring reporting at 2-year intervals is notjustified because production does not change that N 

### frequently formany chemicals. For chemicals that are produced inbatches, such an approach would provide misleading information. Many maintained that EPA has underestimated the burden that would be imposed bythis approach while it has overestimated the degree ofdata obsolescence forthe 2-year period. They suggested that the frequency for recurring reporting be determined after theAgency has obtained initial submissions under this rule and compared thenew data againstthe 1977 data to determine theextent to which the information has become out-of-date.

Second, a number ofcommenters indicated thatEPA has underestimated the burden associated with the determination of whether a reportable event has occurred. Theymaintained that, inmany cases, it would be less burdensome to simply submit a report. Some commenters argued that reporting triggers would penalize smaller companies more because they are less equipped to make a determination of whetherreporting is necessary and would therefore tend to overreport.

Third, mostofthe commenters suggested that, ifEPA decides that it must include a recurring reporting provision in the final rule, the Agency should consider requiring recurring reporting on allreportable chemicals every 5 years regardless ofwhether a reportable event has occurred during that period. The 5-year interval corresponds to the periodused by the U.S. Census Bureau for its Census of Manufacturers. The commenters argued that this approach would provide EPA with a more complete update each time, though less frequently. EPA willbe able to maintain a relatively current data base. The commenters contended that,

even using EPA's own estimate, the Inventory would only be 62.5percent obsolete and would still be more current than thepresent Inventory which EPA has been using forthe past 8 years. The commenters also pointed out that this' approach would be less burdensome to both EPA and industry, because the absence ofreporting triggers would further simplify the reporting and recordkeeping requirements under this rule and would make EPA's compliance monitoring much easier.

EPA'sresponse.EPA's original proposal that recurring reporting be triggered by the occurrence ofa reportable event was based on the belief that this approach would allow the Agency to maintain a current data base without imposing an unreasonable burden on both theAgency and the submitters. After carefully reviewing the comments on this issue,EPA concludes that theproposed approach may not offer as many advantages as theAgency previously believed. Therefore, EPA agrees with the commenters that compliance with therequirements ofthis rulewill be simpler and more straightforward ifrecurring reporting is not event-triggered.

Thequestion ofwhether the determination ofthe occurrence of a reportable event is more burdensome than actualreporting willmost likely vary from submitter to submitter.The Agency still believes that thereportable events governing recurring reporting, as proposed in theMarch 12 Federal Register notice, are not overly complicated. In most cases, it would simplyrequire the comparison of production data every 2 years against the data previously reported. For those submitters who have thecapability of storing the information in a computerized system, such a comparison should notbe difficult. However, smaller companies which do
nothave access to computerized systems would have to perform such comparisons manually. Furthermore, recordkeeping requirements could, in mostcases, become open-ended because current production data would be compared against the data last reported reqardless ofits age.

Ifrecurring reporting is triggered by events, EPA's compliance monitoring effort could become, inmany cases, difficult and resource-intensive. The Agency would have to inspect production records before it could conclude that a manufacturer had a 'legitimate reason not to report during a particular reporting period. On the other hand,ifrecurring reporting is automatic, there will be fewer records to inspect because more manufacturers willhave to report each time.

EPAbelieves that the provision governing recurring reporting shouldbe part ofthe final rule and therefore disagrees with therecommendation that the frequency ofrecurring reporting be determined at a later date. By the time the initial submissions under this rule

can be analyzed and compared against the 1977 data, the existing data would be almost 10 years old. There could have been successive changes at a plant site which could make such a comparison both difficult and inconclusive.

Based on these comments, EPA has adopted the concept ofautomatic recurring reporting every 4 years on al! reportable substances with a sitespecific production volume of10,000 pounds or more. Although recurring reporting will occur less frequently, as compared to the originally proposed 2-
year interval, each round ofreporting will provide a much more complete update of the information. Based on its experience with the 1977Inventory data, EPAbelieves that the 4-year reporting interval would be reasonable, since this would enable the Agency to maintain a relatively current data base without imposing an unreasonable reporting burden on industry.

C.Definitionof Polymer

Comments.Eleven commenters urged EPA tobroaden the "definition" of polymer by including such terminologies

as "homopolymer," "copolymer," and "terpolymer," and/or to add the definition forpolymer used under the section 5(h)(4) premanufacture notification polymer exemption rule (40 CFR 723.250(b)(11)).

EPA'sresponse.EPA disagrees with these comments fortwo reasons. First, the terminologies used to describe polymers, as discussed in the proposed rule, already provide sufficiently broad
coverage ofsubstances with a polymeric
structure. Some ofthe terminologies suggested by the commenters, i.e., "homopolymer," "copolymer," and "terpolymer," are already covered.

Second, the definition used for identifying polymers for consideration under the section 5(h)(4) polymer exemption rule, (40CFR 723.250(b)(11)) is not the only criterion which determines whether a substance is qualified for exemption under that rule. Additional criteria must also be satisfied before a substance can be considered as eligible for exemption. Some ofthe criteria require that an eligible polymer not contain certain reactive functional groups or elements,
not be a biopolymer or its synthetic equivalent, not contain less than 32.0 weight percent of atomic carbon, and
must have a number-average molecular weight of at least 1,000. A substance that does not fully satisfy all of the criteria listed in the polymer exemption rule will not qualify for consideration even'ifit is a polymer defined under 40 CFR 723.250(b)(11). Therefore, it would 

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notbe appropriate to include that definition without the accompanying criteria. If the criteria are also used. many polymers that are currently excluded from thisrule would no longer be eligible for exclusion.

Since issuing the March 12 Federal Register notice, EPA has closely examined the completeness of the terminologies that were used in the proposed rule to identify polymers.As a result ofthis review, EPAhas refined the terminologies forthe final rule.The refined terminologies, which are discussed in Unit IV. above, identify virtually all those substances on the Inventory that are generally considered

as polymers.

D. ChemicalExclusions

Comments.Almost all of the commenters agreed with the four chemical exclusion categories proposed by EPA. One commenter, however, strongly opposed excluding any chemical categories from the requirements ofthis rule. This
commenter contended that the Inventor3 data base is too important to update only partially, and that section 8(b) of TSCA requires thatthe entire Inventory be kept current.

EPA'sresponse.EPA believes that the exclusions proposed in the March 12 Federal Register notice are justified. Section 8(b) ofTSCA requires the Agency to " * * compile, keep current, and publish a listof each chemical substance which is manufactured or processed in the United States." EPA has already been fulfilling this mandated obligation ofkeeping the Inventory current by continually adding to the list those newly manufactured substances that have completed section 5 PMN review, and by periodically removing from the Inventory those subftanes which were misreported when the Inventory was compiled and replacing them with the corrected chemicil identities. The production volume and plant site data associated with the substances on the Inventory

were not collected for the purposes of the section 8[b)Inventory. Rather. these 'data were reported under the authority ofsection 8(a). The "keep current" provision under section 8(b) is restricted
to the addition ofnewly manufacturedsubstances and does not apply-to the production volume and plant site data associated with Inventory substances.

EPA must independently determine the need for collecting current -datafor these substances under section 8(a) of TSCA. Thereasons forexcluding-the four categories were given-in the March 12 Federal Register notice. IfEPA were

.. to require manufacturers to report.data 

### onevery substance listed on the Inventory.this wouldresult in an unnecessary reporting burden for the submitters, and the additional information would be "ofno practical utility" to theAgency, thus violating the Paperwork Reduction Act's standards forinformation collection. However, the Agency has included in the finalrule a provision which requires thereporting of current dataon an excluded substance if such substance is the subject ofa rule or
an orderissued under TSCA section 4. 5, 6,or 7.This provision will ensure the availability ofcurrent information if EPAhas expressed a concern in the form ofregulatory action on any ofthe substances otherwise excluded from the rule.
E.Petroleum RefineryStreams
Comments.Six commenters responded to EPA's request for comment

on whether petroleum refinery streams should be excluded from this rule. They pointed out that,forTSCA purposes, EPAshould be concerned aboutthe potential health and environmental effects ofproducts rather than intermediate process streams. The petroleum refinery streams are bytheir nature site-limited and maintained within closed systems. It is normally only the final petroleum products that leave the refinery and enter into

commerce. The commenters argued that production volume data for refinery streams are unnecessary tothe ' evaluation ofproducts, and can be used inappropriately to give misleading results because they do not necessarily reflect theproduction volumes for commercial petroleum products. Furthermore, they also pointed out that the refining and manufacture of petroleum products is a mature technology, and no new refinery streams

or petroleum products have everbeen added to the Inventory through the PMN process. Nor are majorchanges in refinery technoloqy anticipated which would significantly change the composition ofrefinery streams. Therefore, the commenters believed that

.abroad-based Inventory update of petroleum production statistics would

serve littlepurpose in the absence of technological developments or volume changes with potential impacts on human exposure orenvironmental release. Even ifEPAcan establish a need for such data, reporting under this rule will notbe necessary because the data are already reported to the Department ofEnergy (DOE).

In addition to petroleum refinery streams,fifteen commenters also suggested additional substancesfor exclusion. EPA's responses to these suggestions are included in the public record forthis rule and arenot discussed in this unit.

EPA'sresponse.EPA disagrees with the contention that intermediate process streams are inappropriate subjects of risk identification activities under TSCA. EPA has never limited its focus toonly final products sold in commerce. Since intermediate products can raise

concerns with regard tooccupational exposure and release to theenvironment duringproduction and processing operations, itis oftennecessary to know thetotal production volume ofa stream which may appear as a fraction of

numerous products. Ifsuch a fraction is hazardous, it is important to know the total volume in commerce. EPA routinely uses totalproduction volume

as a decision factor in preliminary risk identification activities.

Regarding the availability of production dataat DOE,as claimed by these commenters, EPA has reviewed reports published by theDOEEnergy Information Administration (EIA) and concluded thatsite-specific production volume information on refinery streams is notavailable. EPAbelieves that the rationale forsite-specific information on petroleum refinery streams andproducts is basically the same as therationale for any other types ofsubstances. For the purposes ofTSCA. EPA needs sitespecificproduction volume information
to support assessment ofthenumber of workers who maybe exposed at a site, the general population at risk in thearea surrounding a site, and the chemical concentration in waterways downstream from each site. Sitespecific information is also needed to support the assessment ofeconomic impacts on affected companies in rulemaking under TSCA, and to determine thenumber ofreports that

can be expected for each reporting rule. Aggregated production data, which are readily available from EIA, do not provide useful information for any ofthe aforementioned analyses.

F.

Duplicative Reporting
Comments.Two commenters requested thatEPA clarify the potential duplicative reporting requirements between this rule and other TSCA section 8(a) rules including the yet-to-be proposed Comprehensive Assessment Information Rule (CAIR).

EPA's response.EPArecognizes that there could exista potential for duplicative reporting among the various section 8(a)reportingrules, especially regarding production volume data.The Agency has decided that ifsimilar information has been submitted under a

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section 8(a),rulefora-substance within. theyear preceding; the start ofa reporting,period under.this.rule;.thesubmitter will not.be required to report. the sameinformation-again forthat reporting period..

G. ReportingbyImporters
Comments.One.commenter asked EPA to clarify in the final'rule which person has the responsibility to report
as the "importer' ofa, particular substance as was done in the PMN rule.

EPA'sresponse.EPA recognizes that

more than one person might meet the definition of"importer" in §710.2(1) of the original.Inventory Reporting.Rule and §704.3 ofthe general section 8(a) definitions fora particular import. transaction involving a-particular substance. For PMN purposes, to address,the same problem, EPA decidedto define a "principal importer'"(40'CFR 720.3(z)), which in most cases willbe the person most knowledgeable about a
new chemical substance; andto require thatperson to submit the PMN.For this rule EPA has decided'not to designate which "importer" should reportfora particular import transaction involving a, specific chemical.substance. Rather, EPA will leave itto the parties to-the transaction to determine which will report. Section 710.35(b),ofthe-rule makesiclear that EPA wants only a single report for such a transaction,and thatEPA will hold each 'importer" liable ifa required report isnot submitted ordoes notcontain the required information. Thus, ifa company imports a substance several times ina single year at a particular site. and uses different agents each time, the company could choose to submit the report combining all the.imports, orit could designate one ofthe agents to submit the report; provided the-agent had all thenecessary information-about all shipmentsH. Definitionof"Parent- Company"far SmallManufacturer Exemption
Comments..One commenterraised several concerns about the Agency'sdefinition ofthe.terms."parent company" and "small manufacturer," specifically,,the commenter noted that the total annual:sales: criterion ofthe. small manufacturer definition,should not include sales revenue ofparent and/or subsidiary companies. In addition, the commenter noted,that majbrity stock ownership shouldnot be:a determining factor in either the definition of"parent company" orthe determination of responsibility for compliance with. reportingrequirements..

EPA.'s response.In an, effortto simplify this final:rule,.EPAhaw deleted, the text ofseveral definitions-from.the rule, including the-definitions of "parent company" and.'small.manufacturer:" However, these definitions still are applicable to.the final rulebecause they

, are incorporated by reference from the list of standard section 8(a) definitions contained in.40 CFR 704.3.The definitions in §704.3 are not substantively different from the definitions which were contained in the proposed rule. Since thisrule.adopts the definitions contained in-40 CFR 704.3, the commenter's points remain relevant and are addressed-by EPAbelow.

The Agency's.definitions for the terms "parent company" and,"small manufacturer" are part of'the generic reporting provisions for section 8(a)

- rules, and already have been the subject

ofpublic.comment. EPA received, relatively few adverse comments on-the generic definitions. The definition of "parent company' is based on the. concept of.ownership or control, whi'ch often is-determined by-majority stock ownership. This-interpretation ofthe. relationship between parentfirm and subsidiary reflectsprevailing judicial views on-the issue.

The "small manufacturer" definition includes the total annual sales- ofparent firms and subsidiaries, if any, because EPAbelieves that-a broadly defined sales criterion is the. best available measure-of a diversified firm's full financial: resources available for regulatory compliance. For a moredetailed discussion of'this definition, see the preamble-discussions ofboth the

- proposed,and: final Small Manufacturer Exemption Rules (proposed rule,at47 FR, 27206, June 23, 1982;,final rule at 49-FR 45425 November 16, 1984).

EPA does not intend that a parent firm owning a majority of stock in a subsidiary report on behalf of-the subsidiary. Any company that is subject
to reporting requirements under the
terms of thisrule (and that does not' qualify for any of the- exemptions in.the rule)must submit the requisite information, even ifthat firm is a subsidiary of*a larger company; it is up to the companies involved to determine internally who compiles-the requisitedata for submission. In the event of noncompliance. the-legal principles of liability in parent-subsidiary relationships,will govern.
I.RecordkeepingRequirements.

Comments Nine organizations expressed concern that.the,proposed recordkeeping requirements would-be unnecessarily burdensome. In generalI,., there-are two- main.objections. First, the commenters,believed,thatthe proposed 5-year record retention,time isnot justified. A 2-year period would be, consistent with standard practice. Second, they objected to the requirement thatthe submitters must document- decisions,not to report..Some, indicated.that thisrequirement would: take away the-benefits:of the various exclusions and.exemptions. Furthermore, all ofthe commenters urged EPA to provide detailed guidance regarding how and whatrecords should. be kept.

EPA's response.EPA agrees that,,as proposed, theactual recordkeeping time; could be open-ended. This,is because a submitter, in order to make a determination ofwhether recurring, reporting isnecessary, would have.to. compare, for each reportable substance,
current data against the information that

was lastreported. To make that comparison, the.submitter would have
to maintain records of the last reporting. almost indefinitely; oruntil a reportable
event occurs. This is-one of'the major disadvantages of the event-triggered approach for recurring reporting. Sincethe-Agency has abandoned the previously proposed event-triggered' approach, recordkeeping time for the
purpose ofthis rule.will no longerbel open-ended. However,.there must:be adequate time: fromthe closing ofa reporting period for theAgency to anaryze the submissions and to examine the corresponding records ifan: inspection of a-particular plant site is found to,be necessary. For this reason, EPA believes that a 2-year recordkeeping period.;,.as suggested-by the commenters,. will.not be sufficient. As a minimum.,relevant records for,a reporting period must be retaineduntil, the start ofthe.next. round.ofreporting,' i.e., for the entire.4 years between.2 reporting periods.

The proposed.requirement that submitters document decisions.that reporting is not necessary was also. closelyrelated to the proposed eventtriggered-approach for.recurring reporting..This requirement,meant that the submitters should be able to show evidence, upon request; thatrecurring: reporting-was-not necessary because a reportable-event had notoccurred during a particular period oftime. Since
most ofthe reportable events relate to production; the-submitter's prodictionrecords would have been sufficient evidence Contrary to what many, commenters believed, the-Agency had, never.intended to.extend the.scopeof' thi'n requirement to cover persons'wh9:'•

are not subject to this rule or the

, excluded chemical categories. For the purposes ofthis.rule , only those records. that show the'production:volume, plant. '21445

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site, and site-limited status ofeach reportable substance are to be maintained. In the case oflow-volume substances, onlyproduction records must be kept to establish evidence that those substances are not reportable at the current production levels.

. Data AggregationandConfidentiality

Comments. Several commenters suggested that EPApublish prior to the effective date ofthe final rule methodologies that the Agency willuse to aggregate production volume data for public disclosure. One commenter claimed that even aggregated data could be sensitive information, and'thus EPA has no right to publish aggregated data.

.Anumber of commenters urged that EPA allow confidentiality claims forthe signing official ofthe reporting firm and the name and address ofthe technical
contact. They also urged EPA to exempt submitters from resubstantiating claime for confidential.chemical identities if such has been submitted to the Agency within 2years before the final rule takes. effect.

EPA'sresponse.EPAhas yet to determine which ofthe several data aggregation methodologies itis investigating will be used forproduction volume data collected under this rule. Even after a methodology is selected, it is unlikely that EPA willbe able to describe it ingreat detail and still preserve the confidentiality ofthe information to be aggregated. EPA's rationale fornot publishing a detailed description ofthe aggregation is to protect the confidentiality ofthe information.

EPA agrees with the comments on confidentiality claims for the signing official and the technical contact. The reporting formhas been revised to permit these claims to be asserted.

EPA disagrees, however, with the
comment thatresubstantiation of confidentiality claims forchemical identity isunnecessary under this rule if such substantiation has been submitted within 2years before the rule takes effect. EPA is actively reviewing claims ofconfidentiality asserted for information on substances added to the Inventory via the PMN process, and will also actively review claims asserted
under this rule. This review requires upto-date substantiation forthe claims asserted. If the substantiation previously submitted is no longer valid, EPA must have new substantiation for the purposes of thisrule. If the substantiation is still valid, the burden for resubmitting it should be minimal. VI. Rulemaking Record

EPAhas established a public record for this rulemaking (docket number ' OPTS 82015A), which is available for inspection inRm. E-107, 401 M St., SW., Washington, DC 20460, from 8 a.m. to4
p.m., Monday through Friday, except legal holidays. These records include all basic information considered by the Agency in developing this rule.

The following documents are included" in the'rulemaking record:

(1) Analysis ofReporting Requirements for the Partial Update of the TSCA Inventory Data Base.

,(2) Whether and How the TSCA Inventory Data Base Should Be Updated.

(3)Analysis ofTSCA Section 8(a) Small Manufacturer Exemption.

(4)All comments on proposed rule and relevant documents and studies submitted in support of these comments.

(5) A summary ofEPA's responses to the comments on the proposed rule.

(6)U.S. General Accounting Office Fact Sheet for the Chairman, Subcommittee on Commerce, Transportation and Tourism, Committee

on Energy and Commerce, House of Representatives: Chemical InventoryEnvirgnmental Protection Agency's Proposed Inventory Update, December 1985, GAO/RCED-86-47FS.

(7) A Summary ofEPA's Responses to the GAO Report on the TSCA Inventory Update.

(8) Records of all communications between EPA personnel and persons outside the Agency pertaining to the development ofthis rule. (This does not include inter- or intra-agency memoranda unless specifically noted in the index ofthe rulemaking record.)

VII. Economic Impact

Based on exclusions and exemptions discussed in this preamble, EPA estimates that a total of4,800 plant sites will be required to submit an initial report on at least one chemical substance.

EPA estimates that chemical manufacturers subject to thisrule will spend approximately $5.5 million to report forthe initial reporting period. These estimates include both fixed and variable costs.

The fixed costs per plant site to comply with the initial reporting requirements of this rule are estimated
at $946. This includes time to become familiar with the reporting requirements, time to determine which ofthe substances produced at the site are covered by the rule, and time to develop

an ongoing reporting mechanism. Maximum variable costs ofcompliance 

### with the initial reporting areestimated
at an additional $251 per reporting form that must be submitted. Thevariable
costs include time togather necessary data, and time to complete and review a reporting form including a determination ofwhether theinformation should be claimed as confidential.

The fixed and variable cost estimates

were based on the number ofhours that would be required to complete a reporting form. EPA estimates an average of 19 hours fora submitter to become familiar with therule, determine which ofthe substances produced at a plant site is reportable, and develop a reporting mechanism. A maximum of5 additional hours are esfimated for a submitter togather the necessary information and to complete and review

a reportinq form. At an average ofone report perplant site, these estimates allow 24 hours foran average plant site's compliance. This figure could be lower orhigher depending on the number of forms involved at a plant site.

For subsequent reporting years (every fourth year following theinitial reporting year), all plant sites manufacturing a reportable substance will have to file a new reporting form. The total cost ofreporting in subsequent reporting years is projected at $2.2 million. This estimate includes costs for reviewing therule, for making the determination, and for completing a reporting form.

A more detailed economic impact analysis ofthe requirements ofthis rule is included in the rulemaking record.
VIII.Regulatory Assessment Requirements A. Executive Order12291

Under Executive Order 12291, EPA must determine whether a regulation is "major" and therefore requires a Regulatory Impact Analysis. EPAhas determined that thisregulation is not "major" because it willnot have an annual effect of$100 million or more on the economy. It is not anticipated to have a significant effect on competition, costs, or prices.

This regulation was submitted to the Office bfManagement and Budget (OMB) for review as required by Executive Order 12291.
B.RegulatoryFlexibility Act

This rule contains a small manufacturer exemption which generally exempts smallmanufacturers and importers fromall reporting requirements. Therefore, in accordance with the Regulatory FlexibilityAct, 5 U.S.C. 601 etseq.,EPA has determined

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that this rule will not have a' significant economic impact on asubstantial number ofsmall entities.

C. Paperwork ReductionAct
The information collection requirements contained in: this rulewwere submitted.for approval ,toOMB under the provisions ofthe-Paperwork Reduction Act of 1980,,44 U.S.C. 3501 et, seq.The information collection requirements in this final,rule:were approved by OMB and assigned control number 2070-0070.

List of Subjects ih 40 CFR Part710'
Environmental protection, Chemicals; Inventory, Hazardous materials, Reporting and recordkeeping requirements.

Dated: May 29, 1986. Lee M.Thomas, Administrator.

PARi 710-[AMENDED]

Therefore, 40 CFR Part 710 is amended as follows:

1.The authority citation for Part 710 continues to read as follows:-

Authority: 15 U:S.C. 2607(a).
2. By designating the existing §§ 710.1 through 710.8 as Subpart A, the heading for which reads as follows:
Subpart A-Compilation ofthe Inventory

3.By addinga new SubpartB,to read

as follows: Subpart B-Partial.Updating ofthe Inventory Data Base
Sec. 710.23 Definitions. 710.25 Chemical substances for which information mustbe reported. 710.26 Chemical substances forwhich information is not required: 710.28 Persons who must report. 710.29 Persons not subject to this subpart, 710.30 Activities for which reporting.is not required. 710.32 Information tobe reported. 710.33 When to report. 710.35 .Duplicative reporting. 710.37 Recordkeeping requirements. 710.38 Confidentiality. 710.39 Reporting form and instructions for

. submitting information. Subpart B-Partial Updating of the Inventory Data Base §710.23 Definitions.

The definitions in § 704.3 ofthis chapter and §710.2 of this Part apply except as provided in this'section.

(a) "Master'Inventory'File" means EPA's comprehensive list of'chemical substances which constitute the 

### Chemical Substance's Inventory compiled under section 8(b) oftheAct. It includes substances reported'under Subpart A ofthis Part and substances reported under Part 720ofthis chapter. for which a Notice of"Commencement of Manufacture or Import has been received'under §720.120 ofthis chapter.

(b) "Nonisolated 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, but not including tanks or other vessels inwhich the substance is stored after its manufacture.

(c)"Site-limited" means a.chemical substance is manufactured and processed only within a site and is not distributed for commercial purposes.as a substance or as partof a mixture or article outside the site.Imported, substances are never site-limited... > §

710.25 Chemical substances-forwhich Information must be reported.

Any chemical substance which is in theMaster Inventory File at the beginning ofa reporting period described in §710.33, unless the 

### chemical substance is specifically excluded by §710.26. §710.26 Chemical substances forwhich Information Isnot required.

The following categories ofchemical substances are excluded from the reporting requirements of this subpart. However, a chemical substance described in paragraphs.(a), (b), or (c)of this section is not excluded from the reporting requirements ofthis subpart if that substance is the subject ofa rule proposed orpromulgated under §ection 4, 5(a)(2), 5(b)(4), or6 ofthe Act, oris the subject ofan orderissued under section5(e) or5(f) ofthe Act,or is the subject of reliefthat has been granted under a civil action under section 5or 7. oftheAct.

(a)Inorganicchemicalsubstances. Any chemical substance which does nor contain carbon or contains carbon only in the form of carbonato ['=CO3], cyano [-CN], cyanato-[-OCN], isocyano [-NC], or isocyanato [-NCOJ groups,
or the chalcogen analogues ofsuch. groups.

(b) Polymers.(1)Any chemical 

### substance,described with-the word. fragments."*polyin ',.",alkyd!', or; * oxylated" in the.Chemical;Abstracts: Service Index or Preferred.,

- -' , " 

### Nomenclature in theChemical

. Substance Identities section ofthe .1985 edition of'the Inventory or in the-Master Inventory File, where the asterisk.(*) indicates that any sets ofchapacters may precede, or follow,.the-character string defined.

(2)Any chemical substance which is identified in the 1985 edition of the. Inventory or theMaster Inventory File

as siloxane and silicone;,silsesquioxane,



### a protein (albumin, casein,.gelatin, gluten, hemoglobin), an-enzyme, a polysaccharide (starch, cellulose, gum);, 

### rubber, or lignin.This exclusion,, however, does not apply to a chemical substance whichhas been h.ydrolyzed,. 

### depolymerized, orchemically modified. to the extent that the final product is no. longer polymeric in structure..

(c) Microorganisms. Any combination of chemical substances that is a living organism, such as bacteria, eimeria, fungi, and-yeasts. Any chemical substance produced firom such,a living organism.is'reportable unless otherwise" 

### excluded.

(d)Naturallyoccurringbtemical substances.Any naturally occurring chemical substance, as described in § 710.4(b)..The applicability of this exclusion is determined in each case by, the specific activities of the person who manufactures the substance in question. Some chemical substances-can be manufactured both as-described inr §710.4(b) and by means other than those described.in § 710.4(b): Ifa person described in § 710.28 manufactures a chemical substance by means other than those described in § 710.4(b), the person must report regardless of'whether the substance also could have been produced as described: in.§'710.4(b. Any chemical substance that is produced, from.such a naturally occurring, chemical substance described in § 710.4(b) is reportable unlessotherwise 

### excluded.. 

### §710.28 Personswho must'report.

Except*asprovided'in §§ 7i0.29 and 710.30, the following persons are subject
to the requirements of this subpart. 

### Persons must determine whether they
must report under this §'710.28 for each chemical substance that they manufacture at an individual site.

(a) Persons, subjectto initialreportinq. Any person who manufactured for commercial purposes 10,000 pounds (4,540 kilograms)'or more ofa-chemical substance.described in § 710.25 at any single site ownedor controlled by that
person at any time during.the person's latest c6mpletI corporate: fisca'yleari'" before August 25, 1986.



### (b) Persons subject to recurring reporting., Any person who manufactured for commercial purposes' 

### '21447

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10,000 pounds (4,540 kilograms) ormore of a chemical substance described in § 710.25 at any single site owned or controlled by that person at any time. during the person's latest complete corpordte,fiscal year before August 25,,i 1990, or before August 25 at four-year intervals thereafter.

(c).Specialprovisions forimporters. For purposes ofparagraphs (a) and (b) ofthis section, the site for a person who imports a chemical substance described in § 710.25 is 'thesite of the operating unit within the person's organization which is directly responsible for importing the substance and which controls the import transaction..The import site may in some cases be the organization's headquarters in the U.S. (See also § 710.35(b).) §710.29 Persons notsubject to this subpart.

A person described in § 710.28 is not subject to the requirements ofthis subpart if that person qualifies as a small manufacturer as that term is defined in § 704.3(r) of this chapter. Notwithstanding this exclusion, a person who qualifies as a small manufacturer is subject to this subpart with respect to any chemical substance that is the subject ofa rule proposed or promulgated under section 4, 5[b)(4), or 6of the Act, or is the subject ofan order in effect under section 5(e) ofthe Act, or is the subject ofrelief that has been granted under a civil action under section 5 or7 ofthe Act.

§710.30 Activitiesforwhich reporting Is not required.

.Aperson described in § 710.28 is not subject to the requirements ofthis subpart with respect to any chemical substance described in § 710.25 that the person manufactured or imported under the following circumstances:

(a) The person manufactured or imported the chemical substance described in § 710.25 solely in small quantities for research and development,

(b) The person imported the chemical substance described in §710.25 as part ofan article,

(c) The person manufactured the chemical substance described in §710.25 in a manner described in §720.30 (g) or (h) ofthis chapter. §710.32 Informationto be reported.

Any person who must report under this subpart must submit the information prescribed in this section,for each chemical substance dessrib!edin §710.25 that the person manufactured for commercial purposes in an amount of 10,000 pounds (4;540 kilograms) or more at a single site during a corporate fiscal year described in § 710.28. (The site for a person who imports a chemical substance is the site ofthe operating unit within the person's organization which is directly responsible for importing the substance and which controls the import transaction, and may in some cases be the organization's headquarters office'in the U.S.). A respondent to this subpart must report information in writing orby computer tape as prescribed in this section to the
extent that such information is known to

orreasonably ascertainable by that
person. A respondent to this subpart
must report information that applies to the specific corporate fiscal year for which the person is required to report. Information on chemical substances for which the chemical identities are • claimed confidential under § 710.38 must be submitted in writing.

(a) Reportingin writing.Any person who chooses to report information to EPA in writing must do so by completing the reporting form contained in § 710.39, and inust submit a separate form for each site forwhich the person is required to report. Information on substances forwhich the chemical identity is claimed confidential under §710.38 must be submitted in writing on

a separate reporting form: a respondent
to this subpart must not report 'confidential and non-confidential chemical substance identities on the

same reporting form.

(b) Reportingby computertape.Any person who chooses to report information.to EPA by means of computer tape must submit the information prescribed in this paragraph (b), and must report separately for each plant site for which the person is required to report. Computer tape submitted inresponse to this subpart
must meet EPA specifications, as described in the instructibn booklet identified in §710.39(b). Persons reporting by means ofcomputer tape also must submit a separate reporting form, with certain basic data elements completed, as specified below, for each site for which the person is required to report. The information to be.reported is

as follows:

(1)On the reporting form, the name, address, city, State, Zip code, and telephone number ofa person who will

serve as technical contact for the respondent company, and will be able to

answer questions about the information submitted by the company to EPA.

(2) On-the reporting form, a

### ' "' ': certification statement signed and dated by an authorized official of the respondent company, and a written
statement on the form that information 

### is being submitted by means of computer tape. The computer tape shall be enclosed with the reporting form.

(3)On the computer tape, the specific chemical name and Chemical Abstracts Service (CAS) RegistryNumber of'each; chemical substance for whichreporting is required under this subpart.A respondent to this subpart may use other chemical.identification numbers in lieu ofCAS Registry Numbers when a CAS RegistryNumber is not known to the respondent as provided in the instruction booklet identified in §710.39(b), including EPA-designated Accession Numbers for confidential substances, EPA-assigned numbers for bona fide orPremanufacture Notifidation submissions orTest Market Exemption Applications, or original Inventory formnumbers.

(4) On the computer tape, thename, street address, city, State, and Zip code ofeach site at which 10,000 pounds (4,540 kilograms) or.more ofa chemical substance for which reporting is required under this subpart is manufactured or imported. (The site for

a person who imports a chemical substance is the site ofthe operating unit within the person's brganization which is directly responsible for importing the substance and which controls theimport transaction, and may in some cases be the organization's headquarters office in the U.S.). A respondent to this subpart mustinclude the appropriate Dunand Bradstreet Number for each plant Sitereported.

(5)On the computer tape, a statement for each substance forwhich information is being submitted indicating whether the substance is manufactured in theUnited States or imported into the United States.

(6)Onthe computer tape, a statement for each substance for which information is being submitted indicating whether the substance is sitelimited.

(7)On the computer tape, the total volume (inpounds) ofeach subject chemical substance manufactured or imported at each site.This amount must be reported to two significant figures of accuracy provided that the reported figures are within ±L10 percent ofthe actual volume.
§710.33 When to report.



### All information reported to EPA in response to the requirements ofthis subpart mustbe submitted during an applicable reporting period. The, followifig'reofing periods are prescribed forthis subpart.

(a) Initial reportingperiod.The first reporting period is fromAugust 25,.1986

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### Federal Register 

## I Vol. 51, No. 113 / Thursday, Junier12, 1986 /'.Rules and Regulations

to October 10, 1986. Any person " described in § 710.28(a) must report during this period for each chemical substance described in § 710.25 that the
person manufactured during the corporate fiscal year described in § 710.28(a).

(b)Recurringreporting periods.The first recurring reporting period is from August 25, 1990 to October 10, 1990. Subsequent recurring reporting periods

are from August 25 to October 10 at 4-
year intervals thereafter. Any person described in §710.28(b) must report during the appropriate reporting period for each chemical substance described in § 710.25 that the person manufactured during the,applicable corporate fiscal
year described in § 710.28(b).

§710.35 Duplicative reporting.

(a) With regard to section8(a)rules.. Any person subject to the requirements of this subpart who previously has complied with reporting requirements of

a rule under section 8(a) ofthe Act by submitting the information described in § 710.32 for a chemical substance described in § 710.25 toEPA, and has done so within one year ofthe start ofa reporting period described in §710.33, is
not required to report again on the manufacture ofthat substance at that site during that reporting period.

(b) With regardto importers.This subpart requires that only one report be submitted on each import transaction involving a chemical substance described in § 710.25. When two ormore persons are involved in :a particular import transaction and each person meets the Agency's definition of "importer" as set forth in § 710.2(1) and § 704.3 ofthis'chapter, they may. determine among themselves who should submit the required report; ifno report is submitted as required under this subpart, EPA -willhold each such
person liable for failure to report..

§710.37 Recordkeeping requirements.

Each person who is subject to the reporting requirements ofthis subpart
must maintain records that document
any information reported to EPA. For substances that are manufactured or • imported at less than 10,000 pounds annually, volume records must be maintained as evidence to support a decision not to submit a report. Records relevant to reporting during a reporting period described in § 710.3.3 must be retained for a period'of four years 

### beginning with the effective date ofthat reporting period. (Approved by the Office ofManagement and Budget under control number 2070-0070) §710.38 Confidentiality. '.



### (a)Any person submitting information under this subpart may assert a

### business confidentiality claim forthe information. The procedures for asserting confidentiality claims are described in the instruction booklet identified in §710.39. Information claimed as confidential in accordance with this section and those instructions will be treated and disclosed ih accordance with the procedures in Part 2 ofthis chapter.

(b) Aperson may assert a claim of confidentiality for the chemical identity ofa specific chemical substance only if the identity ofthat substance is treated

as confidential in the Master Inventory, File as of the time'the report is submitted for that substance under this subpart.

(c) To assert a claim ofconfidentiality for the chemical identity of a specific chemical substance, the person must take the following steps:

(1)The person must report on the form contained in §710.39; 

### not by computer tape.

(2) The person must 

### submit with the 

### report detailed written answers to the -following questions signed and dated by

an authorized official.

(i)What harmful effects to your competitive position, ifany, do you think would result from the identity of the chemical substance being disclosed in connection with reporting under this subpart? How could a competitoruse . such information? Would the effects of disclosure be substantial? What is the causal relationship between the disclosure and the harmful effects?

(ii)How long should confidential treatment be given? Until a specific date, the occurrence ofa specific event,

or permanently? Why?

(iii) Has the chemical substance been patented? If so, have you granted licenses to others with respect to the patent as it applies to the chemical substance? If the chemical substance has beenpatented and therefore • disclosed through the patent,.why should it be treated as confidential?

(iv) Has the identity of the chemical substance.been kept confidential to the extent that your competitors do not know it is being manufactured or imported for a commercial purpose by anyone?. (v) Is the fact that the chemical substance is being manufactured or imported for a commercial purpose available to the public, for example in technical journals, libraries or State, local, orFederal agency public files?

(vi) What measures have you taken to prevent undesired disclosure of-the fact that this chemical substance is being manufactured or imported for a 

### commercial purpose?

(vii)To what extent has the fact that this chemical substance is manufacturpd

orimported for commercial purposes been revealed to others? Whatprecautions have been taken regarding these disclosures? Have there been public.disclosures ordisclosures to competitors?

(viii) Does this particular chemical substance leave the site ofmanufacture in any form, as product, ,effluent, emission, etc.? Ifso, what measures have you taken to guard against • discovery ofits identity?

(ix).Ifthe chemical substance leaves the site ina product that is available to thepublic oryour competitors, can the substance be identified by analysis of the product?

(x) For what purpose do you - manufacture orimport the substance?

(xi) Has EPA, another Federal agency,
or any Federal courtmade any pertinent confidentiality determinations regarding this chemical substance? If so, please attach copies ofsuch determinations.

(3) Ifany of the information contained 

### in the answers to the questions is asserted to contain confidential 

### business information, the person must mark that information as "trade' secret," "confidential," orother;appropriate designation.

(d]Ifno claim ofconfidentiality accompanies informationi ai.the'time it is submitted to EPAjunder this subpart

or ifsubstantiation required Under paragraph '(c) ofthis Section is not. submitted with the reporting form, EPA may make the information available to the public without further notice to the submitter.

§710.39 Reportingform and Instructions for submitting Information.

(a) All persons submitting written 

### information in response to the requirements ofthis subpart mustuse original copies ofthe form contained in this §. 710.39. 

### (b)Complete instructions for

. completing the reporting form and 21449

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### 11-50 Federal Reister/

- ol. 5'I , sN

. 1- ,4 ThuVrsday, June 12, 1986 

## I Rules and Regulations

prepafing a(computertape reporttare given inithe EPA -publicationentitled "InstructionsiforiRqpontingiforithe Partial U.pdatingdfithe TSCA Chemical Inventory'DataBase." !Rqpontirg;forms and instrucfion booklets maybe (obtainedfrom 'thefollowingaddress: 'OTS Document'Coiitrdl Officer:(Room

E-201), US. :Environmerital',Pritection Agency, OfficeofToxic'Stibtances (TS-790), 401 M Street,,SW., -Washington,'DC'20460,Attention: 'Inventory Update Rifle, Telephone: '(202) 382-3698 or.(20Z),755-4880. .(c) Completed 

### 7rporting forms and 

### computertapes must besubmitted toi(he address pecifiedin §710,39(b) above.

(d) The reporting form isias-folows:

IiCLING CODE 6560W50-M

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