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Citation: 50 Fed. Reg. 9944 1985

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### Federal Register / Vol. 50, No. 48 / Tuesday, March 12, 1985 / Proposed Rules

ENVIRONMENTAL PROTECTION
AGENCY

40 CFR Part 710 [OPTS-82015; TSH-FRL 2710-4]

Partial Updating ofTSCA Inventory Data Base; Production and Site Reports

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

SUMMARY: Under the authority of section 8(a) ofthe Toxic Substances Control Act (TSCA),'15 U.S.C. 2607(a), EPA proposes torequire manufacturers and importers ofcertain chemical substances included on the TSCA Chemical Substances Inventory to report current data on the production volume, plant site, and site-limited
status ofthe substances. EPA will use the information collected under this rule
to update the Inventory data base and to support activities associated with the implementation ofTSCA. This action would not affect the status ofchemical substances listed on the Inventory. EPA is requesting comments on this proposed rule. DATE: Comments must be received by May 13, 1985. ADDRESSES: Comments should be forwarded to:TSCA Public Information Office (TS-793), Office ofPesticides and Toxic Substances, Environmental Protection Agency, Rm. E-108, 401M Street SW., Washington D.C. 20460.

Comments must be filed in triplicate and must bear the identifying notation (OPTS-82015). All written comments filed pursuant to this notice, as well as thq rulemaking record, will be available for reviewing and copying inRm. 107, East Tower, at the address given above from 8:00 a.m. to4:00 p.m., Monday through Friday except legal holidays. FOR FURTHER INFORMATION CONTACT: Edward A. Klein, Director, TSCA Assistance Office (TS-7991, Office of Toxic Substances, Environmental Protection Agency, Rm. E-543, 401 M Street SW., Washington, D.C. 20460, toll free: 1800-424-9065], in Washington, D.C.: [554-1404], outside the U.S.A.: [Operator-202 554-1404]. SUPPLEMENTARY INFORMATION:

I.Authority

The Agency is proposing this rule under section 8(a) ofTSCA which authorizes the Administrator ofEPA to promulgate rules under which manufacturers, importers, and
processors ofchemical substances must submit such information as the Administrator may reasonably require. Failure to comply fully with any provision ofthis rule would be a violation of section 15 ofTSCA and would subject the violator to penalties ofTSCA sections 16 and 17.

It is proposed that this rule be promulgated as an amendment to 40 CFR Part 710 which currently contains the Inventory Reporting Regulations. This amendment would designate existing §§ 710.1 througth 710.8 as Subpart A and add a new Subpart B.

II. Summary of theRule

EPA is proposing to require manufacturers and importers to report current data on the production volume, plant site, and site-limited status (i.e., whether a chemical substance is manufactured and processed only within a plant site and isnot distributed for commercial purposes as a substance

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

This rule requires both initial reporting and subsequent reporting. During the initial reporting period, every manufacturer of a chemical substance covered by this rule, unless otherwise exempt, would be required to report on every such substance for each plant site. After the initial reporting, reporting would onlybe required every other year if a reportable event has occurred. Reportable events reflect what EPA considers as significant changes in production volume or site-limited status ofareportable substance. Persons who begin manufacture orimport ofa reportable substance at a particular plant site afterthe initial reporting period would be required to submit an initial report in the first subsequent reporting period.

The substances covered by this rule would include those that were initially reported for the 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

or import:EPAproposes that four categories of substances, though on the Inventory, be specifically excluded from 

### thisrule. These excluded substances are those thatare identified aspolymers, inorganic substances, microorganisms, and naturally occurring chemical substances, as described under §710.4(b) ofthe Inventory Reporting Regulations. Low-volume substances, i.e., substances with an annual sitespecific production volume (or total amount imported) ofless than 10,000 pounds (4,540 kilograms), willgenerally also be excluded from this rule.

In addition to theproposed exclusions ofsubstances, EPAproposes that two categories ofpersons be exempt from all reporting and recordkeeping requirements: Small manufacturers and persons manufacturing substances in

- 

### limited circumstances.

The information reported under this rule would include data on chemical identity, plant site, annual production volume, and site-limited status ofa reportable substance. For each submission, EPAwould alsorequire the
name, address, and telephone number of

a person who can answer technical questions related to the submission. This information wouldbe submitted on EPA-designated reporting forms. Persons subject to thisrule .wouldbe required to maintain records that support the information in their submissions or that document a decision not to report. Suchrecords would be kept for 5years. The format for such recordkeeping would be left up to the individual manufacturer.

III. Background



### A. EstablishmentofInventoryData
Base

Section 8(b) ofTSCA requires the establishment and maintenance ofan Inventory ofchemical substances in United States commerce. To meet this requirement, EPApromulgated the Inventory Reporting Regulations in December 1977.The regulations resulted in the compilation of both the Inventory ofChemical Substances in Commerce and the Inventory database.

The Inventory ofChemical Substances in Commerce is now maintained by EPA in the Agency's Master Inventory File which includes approximately 60,000 substances originally reported for the Inventory and over 1,500 substances which have completed PMN review under section 5(a) ofTSCA and for which a notice ofcommencement of manufacture or import hasbeen received byEPA.

The Inventory data base compiled by EPAcurrently contains only 1977 production information on the approximately 60,000 chemical 9944

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substances originally reported for the Inventory, including:

1.Chemical identity data including Chemical Abstracts Service (CAS] Preferred orIndex Names, CAS Registry Numbers, synonyms, and, wherever available, molecular formulas.

2.1977 manufacturing plant site name and address for each firm that-reported in 1977 as manufacturers ofone or more
orthe 60,000 substances originally reported forthe Inventory.

3.1977 production range for each * chemical substance produced by each reporting plant site.

4. 1977 manufacturing activity. i.e.. whether a submitter was a manufacturer, an importer, or a processor.

5. Whether the substance was sitelimited in 1977.

B. UsesofInventoryDataBase

The production volume, plant site, 5nd site-limited status information contained in the Inventory database have been used by EPA to support numerous TSCA activities. To implementTSCA effectively, EPA requires current knowledge ofwhere and in what quantity chemical substances onthe Inventory are manufactured. This information supports the Agency's investigations ofhealth and environmental effects and'commercial status of chemical substances and the development ofregulations under TSCA.

Production volume information is an important factorin selecting chemical substances forattention because itgives preliminary indications of the potential for human and environmental exposure. In general, EPA needs production data to set priorities forfurther investigation,
to perform first-level screening of chemical 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.

EPA uses plant site data to identify and communicate with manufacturers and to estimate the extent and location ofpotential exposure. Information on whether a substance is site-limited is also used by EPA in estimating exposure. A site-limited substance is presumed to have a lower exposure potential than a substance distributed outside the manufacturing plant site.

The nonconfidential data in the Inventory data base have been used for'
purposes other than TSCA implementation. For example, the National Toxicology Program (NTP) uses the production data as a tool in screening chemical substances for testing and the plant site data to identify and communicate with manufacturers. The EPA Office ofSolid Waste and Emergency Response has used the data base to identify manufacturers of various chemical substances under study and to estimate amounts produced. EPA Headquarters and Regional Offices usethe nonconfidential data to respond to inquiries from State governments, industry, and the public, and to support TSCA compliance monitoring activities.

A more detailed discussion ofthe various usesof Inventory data can be found in a supporting document included in the rulemaking record for this rule.

IV. Need for Updating Inventory Data Base

Data proposed to be gathered under this rule would be used by EPA to update a portion ofthe Inventory data base. EPA needs an accurate and readily available source forbasic information fora significant number of the substances listed on the Inventory. EVA has not been able to identify an alternate data source that can provide the Agency with adequate information in an accurate, complete, and costeffective manner.

This rule would also enable EPA to obtain current production volume information forcertain substances added to the Inventory following the completion of section 5 PMN review and the Agency's receipt ofa notice of commencement ofmanufacture or import. At the present time, the Inventory data base contains production volume data foronly the substances originally reported for the Inventory. For the substances submitted under section 5,production estimates, rather than actual production volumes, are reported. These estimates are not included in the Inventory data base. The actual production volume information that wouldbe reported under thisrule will be added to the Inventory data base and will be used by the Agency to set priorities forfurther investigation of these substances.

A.Age ofInventoryDataBase

Since the Inventory data base contains only information from 1977, the accuracy of the data has been diminishing significantly with time. The growing obsolescence of the Inventory data base has become a matter of increasing concern to EPA. For any of the regulatory purposes previously described, itis important for the Agency tobe able to determine quftkly, accurately, and efficiently who produces these chemical substances, where they

are produced, and in what quantities. The Inventory data base should be the logical data base from which to obtain such basic information. Unfortunately, it
cannot now be relied upon for accurate information because the datahave become increasingly outdated.

Over the past several years, evidence of significant changes in the production volume and plant site for many Inventory substances has been observed. For example, the Interagency Testing Committee (ITC)uses the production ranges in the Inventory data base as its first-level screening for candidate substances for testingunder TSCA section 4.The ITChas found changes in both the manufacturing plant sites and production ranges for many chemical substances reviewed for testing. These changes have complicated the ITC's initial screening process and have complicated the ITC's initial screening process and have forced the ITC and EPA to spend additional time and resources verifying the data listed in the Inventory data base and attempting to obtain current information. Such efforts are not costeffective and do not always produce adequate information.

Similarly, EPA discovered that the plant site information in the Inventory data base was not reliable when the Agency attempted to identify and
contact manufacturers who wouldbe subject to reporting under the section 8(a) Preliminary Assessment Information Rule (40 CFR Part 712]. Major discrepancies were also evident when production volume data collected under the Preliminary Assessment Information Rule were compared against the corresponding production ranges reported for the Inventory data base.

There have been numerous instances in which the Inventory data base has been identified as not providing
accurate information on a particular chemical substance when such information was needed by EPAfor TSCA purposes. In some cases, EPA

was compelled to promulgate chemicalspecific section 8(a) rules to monitor the production level ofthese substances. The lack ofreadily available current production data on these substances has, therefore, complicated the Agency's investigations of chemical substances, compelled the Agency to obtain current information in a resource-intensive and inefficient manner.. 

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B.AlternateSourcesandTheir Limitations

1.Alternatesources.EPA has attempted to obtain current production volume and plant site information, on a case-by-case basis, directly from industry, through the use ofcontractors, and from other existing sources such as:

a. "The SRI Directory of Chemical Producers (DCP)."

b. "Synthetic Organic Chemicals: United States Production and Sales (SYNORG)."

c. "Chemical Economics Handbook (CEH}."

d. "Chemical Marketing Reports."

e. "Chemical Industry Notes." f. Existing internal sources maintained by EPA and other Federal agencies.

2. Limitations.The use ofsources other than the Inventory data basehas three major limitations.

First, many existing sources ofsimilar information, whether compiled by Government or commercial entities, often do not provide adequate information for EPA's needs under TSCA. Sources other than the Inventory usually contain information on only a limited number ofsubstances. To use production data as a tool in chemical screening, EPA needs a data base which provides .readily available information for the many thousands of substances

overwhich EPA hasjurisdiction under TSCA. A case-by-case search for information would be impractical and costly because ofthe large number of substances involved.

Second, the information from other

sources is often not comprehensive or reliable, does not always relate to specific plant sites, often pertains to product classes rather than specific substances, and, in certain cases, represents plant capacity rather than actual production volume.

Third, certain data bases compiled by other Government agencies often contain company proprietary information which cannot be readily made available to EPA.

V. Substances Covered by the Rule

Reportable substances under this rule would include only those that are listed in the Agency's Master Inventory File as of the time ofreporting and that are not specifically excluded from this rule. Substances which were originally excluded from the initial Inventory under40 CFR 710.2 would therefore not be reportable under this rule.For example, any pesticide when manufactured, processed, or distributed incommerce for use solely as a pesticide would notbe reportable. 

### Prior to the effective date of the final rule, EPA may publish an updated Inventory which will listmost ofthe specific or generic.chemical names of both substances initially reported forthe Inventory and substances subsequently added to the Inventory. Since EPA continually adds to the Master " Inventory File substances thathave undergone PMN review and that are subsequently reported as manufactured

or imported, 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 beginning ofa reporting periodwould become reportable in the next reporting period, unless otherwise excluded from this rule.
VI. Substances Excluded Fromthe Rule

EPA proposes that four categories of substances, although included on the Inventory, be excluded from reporting under this rule.The purpose ofthese exclusions is to focus the information collection effort under this rule on those substances for which the Agency has the greatest need for current information. The four categories of substances proposed for exclusion are polymers, inorganics, microorganisms, and naturally occurring chemical substances.These categories are described below:
A. Polymers

The Inventory covers approximately 15,500 synthetic polymers and biopolymers. Most polymers canbe identified in the Inventory's "Chemical Substance Identities" section or in the Agency's Master Inventory File with the words "polymer(s)" or "polymerized," or theprefix "poly" appearing in the corresponding Chemical Abstracts Service (CAS) Index or Preferred Nomenclature forthat substance. EPA believes that the overwhelming majority ofthe synthetic polymers and biopolymers on the Inventory can be so identified. The few synthetic substances that may be borderline polymeric are named differently on the Inventory and would not, therefore, be excluded from thisrule.

.However, certain biopolymers which

are not always identifiable by the terms "polymer(s)," "polymerized," or "poly" would alsobe excluded from reporting under this rule.These substances are identified in the hierarchy ofsubset headings for the Inventory's UVCB section (i.e., Chemical Substances of Unknown orVariable Composition, Complex Reaction Products, and Biological Materials). These biopolymers are proteins (albumin, casein, gelatin, gluten, hemoglobin),
enzymes, polysaccharides (starch, cellulose, gums), rubber, or lignin. Furthermore, biopolymers which have been chemically modified to the extent that the polymeric structure still remains substantially intact would not be reportable.

EPA's approach to identifying polymers for purposes ofthis exclusion is intended to be relatively simple, so that a quick determination ofwhether a substance is a polymer can be made. An Inventory listing ofa polymer could represent agroup ofpolymers with the

same constituent monomers, irrespective ofthe proportion ofthe

monomers orchain structure. A more sophisticated definition that would characterize individual polymers based

on such criteria as chain structure or molecular weight variations would make

a polymer determination more difficult, especially in view ofhow polymers are listed on the Inventory. The Agency believes that this increased administrative burden would substantially reduce the benefit of the exclusion.

EPA proposes to exclude polymers from the proposed rule for two reasons. First, only a small percentage ofthe polymers reported under the PMN rule

are selected for detailed review because ofconcern about their toxicity,
exposure, or use. Second, it appears unlikely that EPAwill use production volume as a means to perform preliminary screening ofpolymers for further investigation under the existing chemicals review program. Some of the polymers that may become a matter of

concern wouldmost likely be identified by other criteria such as toxicity or use. Therefore, there is no need to use this rule to collect production volume and plant site data on all polymers listed on the Inventory, when only a small number ofthese substances may be assessed further under TSCA. In cases in which production volume and plant

- site data are needed for specific polymers, EPAcould use the authority ofa chemical-specific section 8(a) rule
to obtain the information after those polymers have been identified.

B.Inorganic Substances

Forpurposes of this proposed rule, inorganic chemical substances are substances that do not contain a carbon atom, orcontain carbon only in the form ofcarbonato, cyano, cyanato, isocyano,

or isocyanato groups, orthe chalcogen analogues ofthese groups. Inorganic substances on the Inventory can be 

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easily identified and include approximately 3,000 substances.

The inorganic chemical substances

are proposed for exclusion for reasons somewhat similar to those forexcluding polymers. The hazardpotentials of many inorganic substances are relatively well-established. Thus, it is unlikely that theAgency would use production volume as'a means to perform preliminary screening of inorganic substances. When production data are needed on specific inorganic substances orgroups of inorganic substances, EPA could use the authority ofa chemical-specific, section 8(a) rule to collectthe required information.

C.Microorganisms



### EPA is pioposing to exclude from reporting under this rule about 200 substances that are classified on the Inventory as microorganisms. For purposes ofthis rule, this category includes bacteria, fungi, and yeasts which are easilyidentifiable in the hierarchy ofsubset headings for the Inventory's UVCB section and are also identified on theInventory by their corresponding CAS Preferred Names which are usually standard names for the species. Products ofmicroorganisms
are, however, reportable unless otherwise excluded.

Microorganisms are proposed for exclusion under this rulebecause EPA is formulating its policy in the area of biotechnology, and TSCA information requirements formicroorganisms are still being determined. Therefore, it would notbe necessary to collect sitespecific production data for microorganisms at this time. Information requirements relative to microorganisms willbe addressed under a separate rule.
D.NaturallyOccurringChemical Substances

The Inventory includes a group of substances which may be naturally occurring, as described in §710.4(b) of the original Inventory Reporting Regulations. These substances were not reportable underthe Inventory Reporting Regulations, although they.are included on the Inventory. For this
reason, EPAis proposing to exclude from thisrule all naturally occurring chemical substances produced as described in §710.4(b). However, persons who produce a substance in a
manner other than as described in §710.4(b) would be required to report.

This proposed exclusion would cover chemical substances which are naturally occurring and which are unprocessed or processed only by manual, mechanical,

orgravitational means, by dissolution in water, by flotation, or byheating solely to remove water or which are extracted from air by any means. Examples of such substances include raw agricultural commodities, water, air, naturalgas, crude oil, minerals, ores, and rocks.

E. Other PossibleExclusions
In addition to the four categories of substances proposed for exclusion, EPA is alsoconsidering excluding other categories ofsubstances from this rule. The possible candidates forexclusion include those substances that are petroleum refinery streams and wastes,

as well as otherUVCB substances. EPA invitespublic comments on these additional categories.

VII. Persons Subject tothe Rule

Except for those described in Unit VIII below, a person would be considered to be a manufacturer subject to thisrule if that person has manufactured or imported forcommercial purposes a reportable substance at any time during that person's most recent complete corporate fiscal year immediately preceding the effective date ofthe rule

or any subsequent reporting period. For example,if the effective date of the initial reporting period wereJanuary 1, 1986, and a company's fiscal year begins

on October 1, the most recent corporate fiscal year forthat company would be October 1, 1984, through September 30, 1985.

A person who has reported manufacture orimport ofa reportable substance under the rule but has subsequently discontinued such manufacture orimport is considered to be a manufacturer subject to this rule for the next reporting period.

This rule includes an initial reporting period and subsequent reporting periods, as discussed in Unit IXof the preamble. In general, all persons subject to the rule wouldbe required to report for the initial reporting. Subsequent reporting will be required only when one ofthe reportable events, as discussed in Unit IX, occurs. VIII. Persons Exempt From the Rule

EPA isproposing that two categories ofpersons be exempt from the reporting and recordkeeping requirements ofthis rule ifthey qualify for one ofthe proposed exemptions at the time of reporting.
A. SmallManufacturers

EPA is proposing that small manufacturers (including importers) of reportable chemical substances be exempted from all reporting and recordkeeping requirements ofthisrule except with respect to those who manufacture or import chemical 

### substances regulated under TSCA section 5(e). thepurpose ofthis exemption is to reduce the paperwork burden on smallchemical manufacturers, while ensuring that EPA's basic information requirements willbe satisfied.

Persons would qualify as small manufacturers underthis rule if,at the time ofreporting, theymeet one ofthe two standards specified in therecently promulgated TSCA section 8(a) Small Manufacturers Exemption Rule (40 CFR Part 704). These two exemption standards are as follows:

1.Firststandard. Achemical manufacturer would qualify as "small" under this standard ifthe total annual sales ofall plantsites that it owns or controls (together with those that are owned orcontrolled byits foreign or domestic parent company, if any) are lessthan $40 million. However, ifa manufacturer with total annual sales of less than$40 million produces annually

over 100,000pounds (45,400kilograms) ofa particular chemical substance at a " particular plant site, that manufacturer willnot qualify as small with regard to that chemical substance at thatplant site.

Under this first standard, a company that meets the sales criterion for small but does not meet thevolume criterion for all ofits sites will be subject to reporting orrecordkeeping for a particular chemical substance onlyfor sites producing 100,000 pounds ormore ofthe chemical substance per year.

2.Secondstandard. A chemical manufacturer would qualify as smallif the total annual sales ofall plant sites that it owns orcontrols (together with those that areowned or controlled byits foreign or domesticparent company, if any) are less than $4million, regardless ofthe quantity ofchemical substances produced by that manufacturer.

For purposes of these two standards, total annual sales would mean the total

revenue generated by the sale ofall products, including non-chemical products, that are produced at a plant site. EPAwill consider periodically adjusting, as necessary, thesales values ofboth standards to allow for inflation after the promulgation ofthis rule. The Agency will use an index from the Bureau ofLabor Statistics (BLS)for this purpose: theProducer Price Index for Chemicals and Allied Products. Similarly,EPA recognizes the possibility that the sales values may also be subject todeflationary economic trends. The Agency could adjust the sales values downward ifsignificant deflation

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Companies would use the corporate fiscal year as the 12-month period for which both annual sales and production volume are to be calculated. In the first standard, annual production volume would mean the total amount ofa chemical substance produced or imported during the designated 12 month period..

A parent mahufacturing company would be one which owns or controls another company. Ownership or control would exist when one company owns 50 percent ormore ofanother company's voting stock or other equity rights, or has the power to control the management and policies ofthe other company. This proposed definition is drawn from the 1977 Economic Census Report ofOrganization ofthe United States Department of Commerce.

B.PersonsManufacturing Substancesin Limited Circumstances

EPA is proposing to exempt from this rule persons who manufacture reportable substances either in limited ways or through coincidental manufacture. Section 704.5(a) ofthe general section 8(a) rules exempts persons who manufacture or import substances solely for research and development; §704.5(c) exempts persons who import substances as part of articles. EPA is proposing that these two exemptions apply to this rule without change.

For the original Inventory Reporting Regulations and for the PMN rule, EPA recognized that chemical substances are often manufactured incidental to another operation or upon end use of another substance or mixture.For example, a paper carton producer applies adhesives and inks during the carton-making operation and other chemical substanecs are formed coincidentally as these adhesives and inks dry.EPA has exempted such types of"manufacture" from the original Inventory reporting and from PMN requirements. Accordingly, EPA is proposing to exempt these types of "manufacture" from'this rule as well, because EPA believes thatit does not need information on such coincidental manufacture to update the Inventory Data Base.

Section 720.30(g) ofthe PMN rule would apply to this rule exempting manufacture ofbyproducts which are used only as a fuel, which are disposed ofas a waste, or from which component chemical substances are extracted. Section 720.30 (h)would also apply, exempting manufacture ofimpurities and substances from reactions upon end
use, as well as nonisolated intermediates. IX. Whether To Report
A. InitialReporting

For the initial reporting period, all manufacturers who are subject to this rule would be required toreport on every reportable substance manufactured at each particular plant site. Ifa person later begins to manufacture or import for commercial purposes a reportable substance at a plant site,that person would submit an initial report forthat substance and plant site during the nextreporting period. The initial reporting would enable EPA to establish a base line of
current information on those substances that are in commercial production.

B.Recurring Reporting
After the initial reporting period, reporting would be required every 2 years ifone of the reportable events occurred during the most recent complete corporate fiscal year preceding

a relevant reporting period. For purposes ofthis rule, reportable events reflect what EPA considers as significant changes in production volume, or sitelimited status ofa reportable slibstance. Based on its experience with the 1977 Inventory data, EPAestimates that approximately 12.5 percent ofthe production and site information in the Inventory data base would become obsolete each year. The Agency, therefore, believes that the 2-year reporting interval would be reasonable, since thiswould enable the Agency to maintain a relatively current data base without imposing an unreasonable reporting burden on industry.

For purposes ofthis proposed rule, reportable events that would trigger reporting after the initial reporting are defined as follows:

1.Productionvolume. For reportable substances with a previously reported annual production volume of 10,000 pounds ormore, a reportable event would occur when the previously reported site-specific production volume

or the total quantity imported ofa substance increases or decreases by 5- fold ormore. EPAbelieves that such a magnitude ofchange is significant in terms of exposure potential. When there is a 5-fold, i.e., 500 percent, increase in production volume ofa substance, the Agency believes that such a substantial increase in production volume would result in ahigher exposure potential for the substance. In the case ofa 5-fold, i.e., 80 percent, decrease in production volume ofa substance, the Agency believes that its concern wouldbe reduced, and priorities for regulatory actions may change as a result. 

### Ifa reportable substance is produced at 10,000 pounds or more at a given plant site for the first time since the previous reporting period, this fact would constitute a reportable event for thenext reporting period. Similarly,if production ofa reportable substance

ceases at agiven plant site during the 2 fiscal years sincethe previous reporting period, that factwould be reportable for the next reporting period. No further reporting would be requiredunless and until commercial production ofthat substance has resumed at that plant site at 10,000 pounds or more.

2.Site-limitedstatus.A reportable event would occur when a substance previously reported as site-limited is distributed outside that specific plant site for commercial purposes for thefirst time, orwhen a previously distributed substance covered by this rulebecomes site-limited forthe firsttime.
C.Low-Volume Threshold

EPA is proposing to establish a lowvolume threshold by exempting from initial reporting substances produced at low volumes.For purposes ofthis rule, if the site-specific annual production volume or thetotal amount annually imported fora substance is below 10,000 pounds, no initial reporting would be required.If a person's site-specific annual production volume ortotal amount annually imported increases to 10,000 pounds ormore after the close of the initial reporting period, the person would be required to comply with the reporting requirements ofthis rule for that substance in the first subsequent reporting period.

EPA's reason for exempting lowvolume substances from thisrule is based on its information need. Although EPAmayneed production volume information for certainlow-volume substances, it appears unlikely that the Agency willneed readily available production volume information as a general tool to screen these substances for further investigation. When production volume information is needed for certain low volume substances, EPAcould use the authority ofa chemical-specific 8(a] rule to collect therequired information. EPAbelieves that thisexemption is reasonable and consistent with the Agency's past efforts in exempting low-volume substances fromthe requirements of otherrules promulgated under TSCA.
X.What To Report

Persons who are subject to this rule would berequired to report by completing an EPA-designated reporting form.Proposed reporting forms are 9948

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included in § 710.39 ofthe proposed rule. Detailed instructions forfilling out the reporting forms will be made available prior to the effective date ofthe final rule.

There are two different versions ofthe reporting form, each containing four parts. The first version ofthe form, U-1, would be used by persons i'eporting information on substances whose identity is not confidential at the time of reporting orwill not remain confidential

on the Inventory. The second version of the form, U-2, would be used only by
persons reporting information on chemical substances whose identity will remain confidential on the Inventory.

Parts 1, 11, and III of the reporting form include the certification to be signed by the submitter and require the reporting ofother basic submitter information. Part IV of the form would be used to indicate whether the submission is an initial reporting or a reporting of changes. The extent to which Part V of the form would be completed would depend on the number ofchemical substances reported on that form.

EPA is also examining the feasibility ofallowing certain submitters to report by computer tapes. IfEPA determines that reporting in this manner is a feasible approach, it will provide, prior
to the effective date ofthe final rule, complete instructions stipulating the format specifications for preparing such computer tapes.

The information requirements for this rule are discussed below. In most cases,

a submitter would provide fiscal information for the most recent complete corporate fiscal year preceding the relevant reporting period, unless otherwise stated in this rule.

A. ChemicalIdentity

For each chemical substance covered by this rule, a submitter would be required to provide a specific chemical
name, a CAS Registry Number, and/or other identifying numbers used on the Inventory. Persons would check the published Inventory to obtain the
correct name and Registry Number for their substances. Ifthe identity of a substance is confidential, a submitter would consult the generic names section ofthe published Inventory to obtain an EPA-designated Accession Number for that substance. Ifa person is uncertain whether a reportable substance is covered by one ofthe generic names, the person would have to contact EPA using the bona fideprocedures in § 710.7(g) of the .Inventory Reporting Regulations or' §720.25(b) ofthe PMN rule to determine whether the substance in question is reportable. B.PlantSite Importers would report by their United States headquarters. Each manufacturer would be required to report by specific plant site name and
street address.

Certain manufacturers were permitted
to report for the original Inventory by corporate headquarters, business or Post Office Box addresses, orthrough trade associations and other agents. EPAhas found that data on specific plant sites

are much more useful to the Agency. Plant site data usually enable the Ageny
to develop a more accurate estimation ofpotentially exposed populations and
toidentify and communicate with manufacturers ofchemical substances

more easily.

C.ProductionVolume

Manufacturers would be required to report the quantity ofthe substance manufactured at each plant site in separate reports, importers would be required toreport the total quantity imported, regardless of destination, and the information would be reported in pounds. Although EPA does not plan to prescribe specific accuracy ranges for reporting quantities, a submitter should provide the best available information, i.e., production figures normally maintained at a plant site for business
purposes and known to, or reasonably ascertainable by, a submitter as specified in section 8(a)(2) ofTSCA. Reporting ofinaccurate data would constitute a violation ofthe rule and would subject the violator to EPA enforcement actions.

EPA is proposing that precise production data, rather than production ranges, be reported under this rule because in many applications the Agency has found that the production
ranges reported for the 1977 Inventory data base create a certain degree of uncertainty in estimating exposure. This uncertainty is compounded when information from different plant sites is aggregated. Precise production data would minimize the uncertainties prevalent in the Agency's use ofthe 1977 Inventory production data.

The use of narrower ranges was considered by EPA as an alternative to the wide ranges used for the 1977 Inventory. EPA has not adopted that approach because the Agency believes that production data are not maintained by industry in ranges. Thefefore, the reporting ofprecise production data would not be more burdensome to the submitters and would provide the Agency with more useful information. D. Site-LimitedStatus

Manufacturers would be required to indicate whether a chemical sabstance manufactured at a plant site is distributed for commercial purposes outside that site, including as part of mixtures or articles.Imported substances could not be site-limited.

E. TechnicalContact

Persons reporting under this rule wouldbe required to identify the name, address, and telephone number ofan individual who can answer questions concerning the information on the reporting form. This information would be used by EPA to*resolve reporting

errors or technical problems related to the submission.

XI. Reporting Period

As discussed above, after the initial reporting, reporting ofchanges would

occur at two-year intervals. EPA is proposing an initial reporting period of 120,days beginning on the effective date ofthe rule. EPA believes that such a period will be sufficient for initial reporting. In subsequent reporting years EPAis proposing a reporting period of only 60 daysbecause the volume and burden ofreporting would be significantly reduced. Subsequent reporting periods would begin on the anniversary ofthe effective date ofthe

- rule every two years.

XII. Confidentiality

A. AssertingClaims

Submitters would be permitted to claim information submitted toEPA under this rule as confidential ifrelease ofthe information Would reveal trade
secrets orconfidential commercial or financial information, as provided by section 14 ofTSCA. Claims of confidentiality couldbe asserted only at the time information is submitted to EPA and only in the manner specified in the rule.EPA's procedures for processing and reviewing confidentiality claims are set forth at 40 CFR Part 2, Subpart B.

Any information submitted under this rule could be claimed as confidential,

even ifthe same or similar information (except chemical identity) was not so claimed during reporting for the initial Inventory. However, EPA would strongly encourage submitters to review their claims carefully to ensure that the information in question falls within the protection of section 14 ofthe Act and to limit claims as much as possible.

To claim information as confidential,

a submitter would check the appropriate box and sign the certification statement

on the reporting form.If a submitter 

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failed to do so, EPAwould release the information to the public without further notice to the submitter. As in reporting underthe fnitial Inventory Reporting Regulations, by signing the certification
statement the submitter would certify thatits claims ofconfidentiality are made ingood faith afid that the four statements on the back ofthe form are true foreach claim. Procedures for claiming as confidential information submitted by computer tapes will be specified'at the time ofthe final rule, if EPA determines that reporting in'this

manner is feasible.

Companies that assert claims of confidentiality forchemical identity would follow the procedures set forth in the next section.

B. Chemical Identity
A submitter under this proposed rule couldnot assert a claim of confidentiality for specific chemical identity ofa substance unless the chemical identity is held confidential on the Inventory as ofthe time of the report.All submitters reporting information on a confidential substance would be required to use the EPA reporting form U-2 specially designed for reports on confidential substances and to check the appropriate box indicating a confidentiality claimfor chemical identity. Chemical identity information reported onForm U-1 would be nonconfidential and would be released by EPA withoutprior notification to the submitter.

To assert a claim ofconfidentiality for the identity ofa chemical substance which is confidential on the Inventory, theperson would also be required to substantiate the claim by answering in writing certain questions in §710.39 of the proposed rule. These questions are similar to those used for substantiating claims ofconfidentiality for chemical identity forthe original Inventory Reporting Regulations and forthe PMN rule. Persons who reported for the original Inventory and persons whose substances underwent PMN review and

were subsequently reported as manufactured orimported asserted and substantiated theirclaims of confidentiality forchemical identity at that time. Since considerable time has passed since those claims were substantiated, EPA is proposing that those original submitters, as well as any
new manufacturers ofa given substance who report underthis rulewould be required to substantiate claims of confidentiality for specific chemical identity at the time ofreporting under this rule. When a person submits a report ofchanges in production volume

or site-limited status ofa substance under this rule, theperson would be required to substantiate the claim again. However, ifcircumstances with regard to the claim ofconfidentiality have not changed, such a substantiation could be submission ofa copy oftheprevious substantiation.

Ifa manufacturer reports under this rule a chemical substance whose identity is held confidential on the inventory, and the manufacturer does not claim the chemical identity confidential, EPA will consider the identity of that substance no longer confidential forpurposes of the Inventory because the fact that someone ismanufacturing or importing it for commercial purposesis not confidential.. In-such a situation, EPAwould inform all thosepersons who report the substance under this rule and who reported forthe Inventory or under PMN that the substance identity will no longer beheld confidential on the Inventory orin the data base. This policy is consistent with the policy adopted for the original Inventory reporting.

EPA strongly'encourages persons who asserted claims ofconfidentiality for chemical identity for substances they reported for the Inventory to reconsider the necessity ofretaining those claims. If

aperson decides not to assert again a claim ofconfidentiality for the identity ofa substance which is on the Inventory, that person would report information on the substance on EPA reporting form U-1.
C.ReleaseofData

EPA will continue to provide the public with sufficient and informative

access to information collected for the Inventory database while protecting submitters' valid proprietary interests. This will be accomplished by disclosing to thepublic allinformation reported that is not claimed as confidential and continuing to release aggregates of confidential production information. By releasing aggregate data, the Agency is able to share with the public at least general information about industry-wide production totals for Inventory substances. EPAis devising a data aggregation methodology that is sensitive to the specific production levels and changes reported under this rule.
XIII. Recordkeeping Requirements

EPA isproposing thatpersons subject to thisrule be required to maintain records thatdocument any information reported or a decision not toreport for up to a 5-year period after thecreation ofthese records. Forexample, ifa person had determined that reporting was not necessary for a reporting period because the production volume of a substance did not change sufficiently to 'be a reportable event, that person would be required to retain records supporting that determination fora 5-year period.

EPA believes that the types of information being requested under this rule are readily available to a submitter, and that the records supporting reporting under the proposed rule will be records that the submitter would normally retain in the course of conducting business.

XIV. Economic Impact

Based on the proposed exclusions and exemptions discussed in this preamble, EPA believes that approximately 15,000 chemical substances would be covered by this rule.EPA estimates that a total of4,600 plant sites would be required to submit an initial report and that approximately 25 percent ofthese sites would be required to report in a subsequent reporting period.

EPA estimates that chemical manufacturers subject tQ this rule will spefid a maximum of$5.184 million to .reportfor the initial reporting period. These estimates include both fixed and variable costs.

The fixed costs per plant site to comply with the initial reporting requirements ofthis rule are estimated
at$911. This includes time tobecome familiar with the reporting requirements, time to determine which ofthe substances produced at that site is covered by the rule, and time to develop

an ongoing reporting mechanism. Maximum variable costs of compliance with the initial reporting are estimated
at an additional $242 per reporting form that must be submitted.The variable
costs include time togather necessary data, and time to complete and review a reporting form including a determination ofwhether the information shouldbe 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 the rule, determine which ofthe substances produced at a plant site is reportable, and develop a reporting mechanism. An additional 4.6 hours are estimated for a submitter to gather the necessary information-and to complete and review a reporting form. At an average ofone report per plant site, these estimates allow 23.6 hours for

an average plant site's compliance. This figure could be lower or higher depending on the number of forms involved at a plant site. 

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## / Tuesday, March 12, 1985 / Proposed Rules

For a subsequent reporting period, all plant sites manufacturing a reportable substance would have to make a determination ofwhether a reportable change has .occurred during the specified period. EPA estimates that only 25 percent ofthese plant sites would be required to report changes. The total cost to manufacturers who must report during a subsequent reporting period is estimated to be $201,000. This estimate includes both the cost for making the determination and forgathering information and completing a reporting form. Additionally, the total cost to the 75 percent ofnon-reporting plant sites that have to make a determination is estimated to be $418,000.

A more detailed economic impact analysis ofthe requirements ofthis rule is included in the rulemaking record.

XV. Alternatives

In developing its approach for updating the TSCA Inventory data base, EPAreviewed a number ofoptions ranging from a complete update of the entire Inventory data base to no update. In its evaluation of the various options, EPA considered the need for current information and the cost to the Agency for obtaining the required information as wdll as the reporting burden on industry. EPA believes that the proposed approach will provide the Agency with adequate, but not unnecessary, information that it needs to conduct its activities underTSCA, while not imposing any unreasonable burden on industry or the Agency.

A possible alternative that EPA may consider would require manufacturers subject to this ruleto submit information ifa reportable event has occurred within

a three yearperiod. As compared with the proposed approach, recurring reporting under this option would occur less frequently and thus the burden imposed on manufacturers would be reduced; however, this option would result in the Inventory data base being less accurate (by the third year approximately 37.5 percent of the Inventory data base would be out of date). Thus, EPA believes that the threeyear interval may not represent the most appropriate balance between maintaining a relatively current data base and minimizing excessive reporting burden.

Another alternative that EPA may consider and would require manufacturers subject to this rule to automatically submit current information all reportable substances
every three years. Since recurring reporting under this option would not be triggered by the occurrence ofa reportable event, there would be more reports. However, manufacturers would not have to determine whether recurring reporting is necessary and this may further simplify the recordkeeping procedures. EPA invites public
comments on these reporting alternatives.

A discussion of other alternatives considered but not adopted by EPA is included in a supporting document in the rulemaking record.

XVI. Rulemaking Record

Therecord for ihis proposed rulemaking includes basic information considered by the Agency in developing thisproposed rule. The following documents are included in the rulemaking record:

(1) Analysis ofreporting requirements for the partial update ofthe 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.

The Agency will supplement the record with the following types of additional information as they are received ordeveloped:

1.All comments on this proposed rule. 2. All relevant support documents and studies.

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

4. Minutes, summaries, or transcripts ofany public meetings held to develop this rule.

5. Any factual information considered by the Agency in developing the rule.

EPA will identify the complete rulemaking record on or before the date ofpromulgation ofthe rule, as prescribed by section 19(a)(3) ofTSCA, and will accept additional material for inclusion in the record at any time between this notice and that date.

XVII. Judicial Review

When this proposed rule is promulgated, judicial review may be available under section 19 of TSCA in the United States Court ofAppeals for the District ofColumbia Circuit or for the circuit in which the person seeking review resides or has his principal place ofbusiness. To provide all interested persons an equal opportunity to file a timely petition forjudicial review and to avoid so-called "races to the courthouse," EPA intends to promulgate this rule for purposes ofjudicial review two weeks after publishing the final rule in the Federal Register.The effective 

### date willbe calculated from the promulgation date.
XVIII. Regulatory Assessment Requirements

A. Executive Order12291


### UnderExecutive Order 12291, EPA
mustdetermine whether a regulation is "major" and therefore requires a Regulatory Impact Analysis.EPA has determined that this proposed regulation is not "major"because it willnot have

an annual effect of$100 million or more
on the economy. Itis not anticipated to have a significant effect on competition, costs, orprices.

Thisregulation was submitted to the Office ofManagement and Budget (OMB) forreview as required by Executive Order 12291.

B.RegulatoryFlexibility Act


### Thisrule contains a small manufacturer exemption which would exempt smallmanufacturers from all reporting requirements. Therefore, in accordance with the Regulatory Flexibility Act, 5 U.S.C.601 etseq., EPA 

### has determined that this rule will not have a significant economic impact on a substantialnumber ofsmall entities.

C.PaperworkReductionAct



### The information collection requirements contained in this proposed rule havebeen submitted for approval to OMB under theprovisions ofthe Paperwork Reduction Act of 1980, 44 U.S.C. 3501 etseq. Comments on the 

### information collection request (not on the substantive content of therule itself) shouldbe submitted to the Office of Information and Regulatory Affairs of OMB, marked "Attention: Desk Officer for EPA." The final rule willrespond to any OMB or public comments on the information collection requirements. (Sec.8 (a), Pub. L.94-469, 90 Stat.2027 (15 U.S.C. 2607)) ' 

### List of Subjectsin 40 CFR Part710

Environmental protection, Chemicals, Inventory, Hazardous materials, Recordkeeping and reporting requirements.

Dated: March 3,1985. Lee M. Thomas,

Administrator.

PART 710-[AMENDED]



### Therefore, it is proposed that Part710 be amended as follows:
§§ 710.1-710.8 (Designated asSubpart A)



### 1.By designating theexisting §§.710.1 

### through 710.8 as Subpart A, entitled: 9951

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### Reister / Vol. 50. No. 

### 48/ Tuesday, March 12, 1985 / Proposed Rules

Subpart A-Compilation ofthe Inventory

2. By.adding anew Subpart B to read

as follows:
Subpart B-Partial Updating ofthe Inventory Data Base

Sec. 710.23 Definitions. 710.25 Chemical substances to be reported. 710.27 Persons subject to this subpart. 7.10.28 Persons not subject tothis subpart. 710.30 Reporting requirements. 710.33 Recordkeeping requirements. 710.38 Confidentiality. 710.39 Reporting forms. (Sec. 8(a), Pub. L.94-469, 90 Stat.2027 (15 U.S.C. 2607))
Subpart B-Partial Updating ofthe Inventory Data Base §710.23 Definitions.

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

(a) "Manufacturer" means a person who manufactures or imports a chemical substance for commercial purposes. A
person who extracts a component chemical substance from a complex combination ofchemical substances is a manufacturer ofthat component chemical substance.

(b) "Master Inventory File" means EPA's comprehensive list ofchemical substances which constitute the Chemical Substances Inventory compiled under section 8(b) of the Act. It includes substances reported under Subpart A ofthis Part and substances reported under Part 720 of this chapter for which a Notice ofCommencement of Manufacture or Import has been received under § 720.120 ofthis chapter.

(c) "Non-isolated intermediate" means any intermediate that is not intentionally removed from the equipment in which itis manufactured, including the reaction vessel in which it ismanufactured, 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 orother vessels in which the substance is stored after its manufacture.

(d) "Parent company" means a company which owns or controls another company. Owership or control exists when one company owns 50 percent or more ofanother company's voting stock or other equity rights, or has the power to control the management and policies ofthe other
company.

(e) "Plant site" means a contiguous' property unit under the ownership or control of a manufacturer or importer. Property divided only by apublic rightof-way is one plant site. There may be

more than one manufacturing facility on

a single plant site. For an importer, the plant site is the importers's United States headquarters.

(f) "Site-limited"means that the chemical substance in question is manufactured and processed only within a plant site and is not distributed for commercial purposes outside the plant site as a chemical substance or as part ofa mixture ofarticle. No imported chemical substance is site-limited.

(g) "Small manufacturer" means a manufacturer meeting either of the following standards:

(1)Firststandard. A manufacturer is "small" under this standard ifthe total annual sales ofall plant sites that it

owns or controls (togetherwith those that are owned orcontrolled by its foreign or domestic parent company, if any) are less than $40 million. However, if a manufacturer with total annual sales ofless than$40 million produces annually over 100,000 pounds (45,400 kilograms) ofa particular chemical substance at a particular plant side, that manufacturer will not qualify as small with regard to that chemical substance
at thatplant site. (Forimports, the 100,000 pound figure applies to the total
amount imported.)

(2) Secondstandard. A manufacturer is small under this standard ifthe total annual sales ofall plant sites that it

owns or controls (together with those that are owned or controlled by its foreign or domestic parent company, if any) are less than $4 million, regardless ofthe quantity ofchemical substances produced by that manufacturer.

(h) "Total annual sales" means the total annual revenue (indollars) generated by the sale ofall products ofa plant site.
§710.25 Chemical substances to be reported.

(a)Inclusions,Any chemical substance which is in the Master Inventory File at the time ofa reporting period specified in § 710.30(c) is subject
to the reporting requirements ofthis subpart unless specifically excluded by paragraph (b) of this section.

(b) Exclusions.The following categories ofchemical substances are excluded from reporting under this subpart:

(1)Inorganic chemicalsubstances. Any chemical substance which does not contain carbon orcontains carbon only in the form of carbonato, cyano. cyanato, isocyano, or isocyanato groups,

or the chalcogen analogues ofsuch groups. (2) Polymers.(i)Any chemical substances described with the words "polymer" or "polymerized" or the prefix "poly-" in the Chemical Abstracts Service Index orPreferred Nomenclature in the Chemical Substances Identities section ofthe published Inventory or in the Master Inventory File; (ii) Biopolymers that are proteins (albumin, casein, gelatin, gluten,hemoglobin), enzymes, polysaccharides (starch, cellulose, gums), lignin, orrubber. This exclusion also applies to biopolymers which are chemically modified to the extent that the polymeric structure still remains substantially intact.

(3) Microorganisms. Combinations of chemical substances that are living organisms, such as bacteria, fungi, and yeasts. Chemical substances produced from such living organisms are reportable unless otherwise excluded.

(4)NaturallyOccurringChemical Substances.Any naturally occurring chemical substances, as described in §710.4(b). This exclusion applies to the specific activities ofthe person who
must report. Some chemical substances

can be manufactured both as described in § 710.4(b) and by means other than those described in § 710.4(b). Ifa persdn subject to this subpart manufactures a chemical substance by means other than

- those described in §710.4(b), the person must report regardless ofwhether the substance could also have been produced as described in §710.4(b). Chemical substances produced from such naturally occurring chemical substances would be reportable unless otherwise excluded. §710.27 Persons subjecttothissubpart.

Except as provided in §710.28, the following persons are subject to the requirements ofthis subpart:

(a)Initial reporting.(1)Any person who manufactured for commercial
purposes 10,000 pounds (4,540 kilograms) or more of a chemical substance subject to this subpart at a particular plant site during that person's last complete corporate fiscal year before (effective date offinal rule).

(2)Any person who manufactured for commercial purposes 10,000 pounds (4,540 kilograms) ormore ofa chemical substance subject to this subpart at a particular plant site during that person's last complete corporate fiscal year before a reporting period specified in § 710.30(c)(2) for which a report was not previously submitted under § 710.30(a)(1).

(b)Reportingofchanges.(1)Any person who manufactured for commercial purposes a chemical II: eea eitr/Vl.5,N.4 usaM rc 2 95/Pooe ue

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### Federal Register / Vol. 50, No. 48 / Tuesday, March 12, 1985 / Proposed Rules

substance subject to this subpart at any time during that person's lastcomplete corporate fiscal year before a reporting period specified in § 710.30(c)(2).

(2) Any person who ceased manufacture for commercial purposes of

a chemical substance subject to this subpart at a particular plant site during that person's last 2 complete corporate fiscal years before a reporting pertod specified in § 710.30(c)(2).
§710.28 Persons notsubjecttothis sqbpart.

The following persons are not subject to this subpart except as otherwise noted:

(a)Persons described in § 704.5 (a) and (c) ofthis chapter and persons who manufacture a chemical substance subject to this subpart as described in § 720.30 (g) and (h)of this chapter.

(b) Persons who are small manufacturers, except that such persons shall be subject to this subpart with respect to those chemical substances subject to an order issued pursuant to section 5(e) ofthe Act, 15 U.S.C. 2604(e).
§710.30 Reporting requirements.

(a)Initialreporting. Any person described in § 710.27(a) must submit an initial report for each chemical substance subject to this subpart for each plant site at which the substance is manufactured for commercial purposes
as follows:

(1)A person described in § 710.27(a)(1) must submit the report during the reporting period described in, paragraph (c)(1) of this section.

(2) Aperson described in §710.27(a)(2) must submit the report during the reporting perioddescribed in paragraph (c)(2) ofthis section which immediately follows the event described in §710.27(a)(2).

(b) Reportingofchanges.Any person described in §710.27(b) must submit a report ofchanges foreach chemical substance subject to this subpart for each plant site at which a reportable change has taken place for that substance since the person last reported

on the production of the substance at that site. Thereport must be submitted during the reporting period described in paragraph (c)(2) ofthis section which immediately follows the reportable change. The following are reportable changes:

(1)For a chemical substance previously reported under this subpart with aproduction volume of 10,000 pounds (4,540kilograms) ormore at a particular plant site, an increase in the previously reported production volume of500 percent or more, or a decrease in such volume of 80 percent ormore, as 

### measured by theproduction volume at that plant site forthe mostrecent complete corporate fiscal year preceding the reporting period.

(2) For a chemical substance 

### previously reported under this subpart with a production volume ofgreater than zero butless than 10,000 pounds (4,540kilograms) at a particular plant site, an increase in production volume to 10,000 pounds ormore, as measured by theproduction volume at that plant site forthe mostrecent complete corporate fiscal year preceding the reporting period.

(3)For a chemical substance previously reported under this subpart with a production volume of10,000 pounds (4,540kilograms) ormore at a particular plant site,cessation of manufacture at that site during the last two complete corporate fiscal years before the reporting period.

(4) fora chemical substance for which

a cessation ofmanufacture ofthat substance waspreviously reported under this subpart at a particular plant site,manufacture of10,000 (4,540 kilograms) pounds ormore, as measured by the production volume at that plant site for themost recent complete corporate fiscal year preceding the reporting period.

(5)For a chemical substance with a production volume of10,000 pounds

- 

### (4,540kilograms) ormore at a particular plant site:

(i)A ehange in status from site-limited for a plant site at which it was previously reported as site-limited.

(ii) A change in status to site-limited fora plant site at which it was previously notreported as site-limited.

(c)Reporting periods.All reports required under this subpart mustbe submitted to EPAduring the applicable reporting period. The reporting periods forthis subpart are as follows:

(1)The firstreporting period is from (effective date)to (120 days after the effective date).

(2)The second reporting period is from (effective date plus two years) to (60 days after effective dateplus two years). Subsequent reporting periods are from (effective date, without year) to (60 days aftereffective date,without year) at.2-yearintervals thereafter.

(d)Reporting procedures.Reports under this subpart mustbe submitted on either thedesignated reporting formsor on computer tape as follows:

(1)Reporting forms.Written reports must be submitted in the form and

manner set forth in either EPA FormNo. U-1 orU-2 under § 710.39. Forms may 

### be obtained fromthe TSCA Assistance Office (TS-799), Office ofToxic Substances, Environmental Protection Agency, Rm. E-543, 401 M St., SW., Washington, D.C. 20460. Initial reports under paragraph (a) ofthis section must be submitted on separate forms from reports ofchanges under paragraph (b) of this section. Each form submitted
must indicate whether it is an initial report or a report ofchanges. Form No. U-2 must be used when the specific chemical identity is claimed confidential

as prescribed in § 710.38(c). Information for different plant sites must be submitted on separate forms.

(2) Reportingby computertape. Reports by computer tape must be submitted in accordance with (name of guidance document to be supplied at time offinal rule).

(e) Informationtobereported. Each person required to report under this subpart must report on the production of each chemical substance subject to this subpart at each plant site, to the extent known orreasonably ascertainable by the person, as follows:

(1) A certification, signed and dated by an authorized official, that all information submitted is complete and accurate, that certain confidentiality
statements are true, and thatEPA will bepermitted access to and copying of records to document information reported.

(2) Formanufactured substances, the
name, street address, city, State, and ZIP code ofthe plant site. For imported substances, the name, street address, city, State, and ZIP code ofthe United States headquarters.

(3) The name, street address, city, State, ZIP code, and telephone number ofa technical contact able to answer questions about the information.

(4)The Chemical Abstracts Service Registry Number (and/orother identifying numbers including EPAdesignated Accession Number for confidential substances) and specific chemical name ofeach chemical substance.

(5) Whether each chemical substance is manufactured or imported.

(6) Theproduction volume in pounds, for the person's last complete corporate fiscal year, ofeach chemical substance manufactured orimported, reported as precisely as permitted by the person's routine business records.

(7) Whether the.chemical substance

was site-limited. 

### §710.33 Recordkeeplng requirements.

Each person who is subject to this subpart shall maintain.records that document any information reported and that support any decision not to submit

a report, and shall permit access to and copying ofsuch records by EPA officials 19953

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upon request. Records shall be retained for a period of5years after the creation of such records.
§710.38 Confidentiality.

(a) Any person submitting information under this subpart may assert a business confidentiality claim for the information, as described inthe instructions for the reporting forms in §710.39 or in the instructions for reporting by computer tape. Information claimed as confidential will be treated in accordance with the procedures in Part 2of this title.

(b)A person 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 ofthe time the report is submitted.

(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 EPA Form No. U-2, 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 competitor use 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,

orpermanently? Why?

(iii)Has the chemical substance been patented? Ifso, have yougranted licenses to others with respect to the patent as it applies to the chemical substance? Ifthe chemical substance has been patented and therefore disclosed through the patent,why should it be treated as confidential?

(iv) Has the identity ofthe chemical substance been kept confidential to the
extent thatyour 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 publicly available, for example in technical journals, libraries, or State, local, orFederal agency public files?

( vi) What measures have you taken to prevent undesired disclosure ofthe fact that this chemical substance is being manufactured or imported for a commercial purpose?

(vii) To what extenthas the fact that this chemical substance is manufactured

orimported for a commercial purpose been revealed to others? What precautions have been taken regarding these disclosures? Have there been public disclosures or disclosures 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 in a product that is available to the public oryour competitors, can the substance be identified by analysis of the product?

(x) For what purpose do you manufacture or import the substance?

(xi) Has EPA, another Federal agency,

or any Federal court made any pertinent confidentiality determinations regarding this chemical substance? Ifso, please attach copies ofsuch determinations.

(3)If any ofthe 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," or other appropriate designation.

(d) Ifno claim of confidentiality accompanies information at the time it is submitted to EPA under this subpart

or ifsubstantiation required under paragraph (c) ofthis section isnot submitted with the reporting form, EPA may make the information available to the public without further notice to the submitter.
§710.39 Reportingforms.

All persons subject to this subpart
must use the EPA-designated forms for reporting, unless such reporting is submitted in a computer tape in accordance with §710.30(d)(2). The EPA-designated reporting forms for this subpart follow.

BILLING CODE 6560-50-M 

### 9954

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### Federal Register / Vol. 50, No. 48 /Tuesday, March 12, 1985 / Proposed Rules

I1) Before completing this form, carefully read the accompanying instructions. IMPORTANT (21 Use this form for reporting ifchemical identiy iSNOT claimed confidential.



# u -' 

# fEPA Form Approved. OMB No. 20xx-xxxx Approval expires xx-xx-xx US ENVIRONMENTAL PROTECTION AGENCY PARTIAL UPDATING OF TSCA INVENTORY DATA BASE PRODUCTION AND SITE REPORT (Section8(s) Toxic Substances Control Act 15 USC 2607)
I.CERTIFICATION STATEMENT: Ihereby certifythat (1) all information entered onthisform is complete and accurate, and (2)the confidentialitystatements onthe back ofthisform are true astothat information for which I haveasserted a confidentialityclaim. Iagree to permit accessto. and the copyingof, records bya duly authorized representative of the EPA Administrator, in accordance with the Toxic Substances Control Act, to document any information reported here.

SIGNATURE DATE NAME/TITLE (Type or print)

11.

TECHNICAL CONTACT,om s~m, w ca. sm z, c.,.j III. PLANT SITE alve,.m sow air Cou.ite. zip ca*ri

IV. [ Initial 

### L Report ofchanges

__ _ V. CHEMICAL SUBSTANCE IDENTITY/ACTIVITY/CONFIDENTIALITY

AciW.SITE coNiFiDedTiA. ITY LIMITED CLAIMS

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### 9955

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EPA Form 7740-SA 112-04) EPA COPY

HeinOnline -- 50 Fed. Reg. 9955 1985

### Federal Register / Vol. 50, No. 48 / Tuesday, March 12, 1985 / Proposed Rules

WHERE TO GETSUPPLIES Send Completed Forms To:

TSCA Section Sia) Forms U-i and U-2,and acopyofthe instruction US Environmental Protection Agency booklet may be obtained bycontactingtheTSCA Assistance Office, Office ofToxic Substances OfficeofToxicSubstances, Environmental ProtectionAgency, 401 M Stroet. SW. Washington. DC 20480. TOLLFREE 800-424-9065. PO Box
inWashington, DC 202-554-1404.

CONCERNING EPA DISCLOSURE OF INFORMATION
Any personwho submits information to EPA should be aware of EPA regulations (40CFR Part 2) whichgovern disclosure of such information. Those regulations provide that such person may, if he or she desires, assert a confidentiality claim covering part or all of the information submitted. Information coveredby such a claim will be publiclydisclosed by EPA onlytothe extent,and by means ofthe procedures, setforth in40CFR Part 2. However, if no such claim accompaniesthe information when it is received, EPA may make that information public without notifying the submitter.

CONFIDENTIALITY STATEMENTS

Information except chemical substance identity reported toEPA onthe front ofthis form may be claimed confidential by checkingthe appropriate boxes under "Confidentiality Claims" of Block IV. In certifying this form, the person signing in Block 1 attests to the truth of the following four statements concerning all information (except chemical substance identity)which is claimed confidential.

1. My company has taken measures to protect the confidentiality of the information, and it intends to continue to take such measures.

2. The information is not, and has not been, reasonably obtainable without our consent by other persons (other than governmental bodies) by useof legitimate means (otherthandiscovqry basedon a showing ofspecial need in ajudicial or quasi-judicial proceeding).

3. The information is not publicly available elsewhere.

4. Disclosure of the information would cause substantial harm to our competitive position.

The person signing in Block 1also atteststo thetruth oftheappropriate statement(s)below concerning other information specifically claimed confidential for the particular chemical substance. By checking the box under:
(a) Manufacture/Import: I assert thay my activity as a manufacturer and/or an importer of the chemical substance is confidential (Note;ifonlythisboxischecked,plant site informationis notclaimedas confidentialandmaybe disclosed).
(b) Site Limited: Iassert that the fact thatthe chemical substance is not distributedfor a commercial purpose outside of the plant site identified in Block IIisconfidential. (c) Production: I assert that the production volume of the chemical substance for the plant site identified in Block II is
confidential.
(d) Plant Site: Iassert thatthe link ofthis chemical substance to the plant site identified in Block IIis confidential.

EPA Form 7740-SA (12-84) Reverse 

### 9956

HeinOnline -- 50 Fed. Reg. 9956 1985

### Federal Register / Vol. 50, No. 48 / Tuesday, March 12, 1985 / Proposed Rules

(1) Before completing this form, carefully read the accompanying instructions. IMPORTANT (2) Use this form for revorting only if chemical identity isclaimed confidential. 

# U- 2 

# ,,EPA Form Approved OMB No 20xx-xxxx Approval expires x-.xx-xx
US ENVIRONMENTAL PROTECTIUN AUNCY PARTIAL UPDATING OF TSCA INVENTORY DATA BASE
PRODUCTION AND SITE REPORT (Section 8(a) Toxic Substances Control Act 15 USC 2607)

I.CERTIFICATION STATEMENT: Ihereby certifythat(1) all informationentered on thisform iscomplete and accurate, and (2)the confidentialitystatements on the back ofthisform are trueasto that information forwhich Ihave asserted a confidentialityclaim. Iagree to permit access to, and the copying of, records bya duly authorized representative of the EPA Administrator, in accordance with the Toxic Substances Control Act, to document any information reported here.
SIGNATURE DATE NAME/TITLE (Type orprint)

II.

TECHNICAL CONTACT wM,w sewe , *". Car.state.zop co*) Ill. PLANT SITE (N,. Stret.x C".Stw. ZIP Code)

TELEPHONE NUMBER OF TECHNICAL CONTACT IV. 

### 0 Initial Report [] Report of changes

V.CHEMICAL SUBSTANCE IDENTITY/ACTIVITY/CONFIDENTIALITY

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EPA Formi 7740-8B 112-84) EPA COPY

HeinOnline -- 50 Fed. Reg. 9957 1985

### Federal Register / Vol. 50, No. 48 / Tuesday, March 12, 1985 / Proposed Rules

WHERE TO GET SUPPLIES Send Completed Forms To: TSCA Inventory Updating Forms U-1 and U-2 and acopy o. the US Environmental Protection Agency instructionbooklet may beobtained bycontactingtheTSCA Assist- 

### Office of Toxic Substances
ance Office. Officeof Toxic Substances. Environmental Protection Agency. 401 M Street, SW, Washington, DC 20460, TOLL FREE PO Box 800-424-9065, in Washington. DC 202-554.1404.

CONCERNING EPA DISCLOSURE OF INFORMATION Any personwho submits informationto EPAshould beaware ofEPA regulations (40CFR Part2)which governdisclosure ofsuch information. Those regulationsprovide that such person may, if he or shedesires,asserta confidentiality claim covering part or allof the information submitted. Information covered by such a claimwill bepublicly disclosed by EPA onlytotheextent,and by meansoftheprocedures,setforth in40CFR Part2. However, if nosuch claim accompaniesthe information when it is received, EPA may make that information public without notifying the submitter.

CONFIDENTIALITY STATEMENTS
Chemical substance identityandother information reported to EPA onthefront ofthis form may beclaimed confidential bychecking the appropriateboxes under "Confidentiality Claims" of BlockIV. In certifyingthisform,the personsigning in Block 1attests to the truth of the following four statements concerning all information.

1. My company has taken measures to protect the confidentiality of the information, and it intends to continue to take such measures.
2.The information is nct,and has not been, reasonably obtainable without our consent by other persons (other than governmental bodies)byuse oflegitimate means(otherthan discoverybased on ashowingof specialneed inajudicialor quasi-judicial proceeding).

3.The information is not publicly available elsewhere.

4. Disclosure ofthe information would cause substantial harm to our competitive position.

The person signing in Block 1also atteststothe truth ofthe appropriate statement(s) below concerning the information specifically claimed confidentialforthe particular chemical substance. By checking the box under:
(a) Manufacturi/Import: Iatsert thay my activity as a manufacturer and/or an importer ofthe chemical substar~ne is confidential (Note:ifonlythisboxischecked,plantsiteinformation is notclaimedas confidential andmaybe disclosed (b)Site Limited: I assertthatthefactthat thechemical substance isnot distributedfor a commercial purpose outside of the plant site identified in Blook IIis confidential. (c) Production: Iassert that the productionvolume of the chemical substance for the plant site identified in Block IIis confidential. (d)Plant Site: I assert that the link of this chemical substance to the plant site identified in Block It is confidential.
(e) Chemical Identity: Iassert that the identity of the chemical substance is confidential.
The submitter of thisform, when claiming that the identity of a chemical substance to be confidential, must provide written substantiation for such claim (see instructions)and also must agree to the following statement.
CONFIDE NTIAL CHEMICAL SUBSTANCE IDENTITY STATEMENT

I agreethat EPA may disclose,for purposes of section5(aX1 A)of the Act (premanufacture notification),to any person with abonafide intent tomanufacture the substance(s)identifiedonthis form (asdetermined by EPA under 40710.7(g)) thefactthatthe chemical substance(s)is(are) included onthe Inventory. Further,Ihave or will have availableandagree to furnishto EPA upon request, all Information required in 40 CFR 710.7(e) for the substance(s) identified on thisform.

EPA Form 7740-88 (12-841

IFR Doc. 85-5810 Filed3-11-85; 8:45 am] BILLING CODE 6560-50-C 

### 9958

HeinOnline -- 50 Fed. Reg. 9958 1985