Document oD670a9KjmgOg0N16gZbGrLQo

^SamTWednesday | PLAINTIFF'S November 26, 1980 I || - - ; Is - KM-387 - -. . ic.u..-: . - -V.v- "t! "t:;- iBW-xs-WiU if;' - . 'rg.&jfg,*!* ">x: ' :-,, i % .J. * ,, . C;.. % :.-C SiaA&.'fS&t'Z'lSft .. ; .', v- ' ..' ... ;-:n* - / r' . '-!"A . : hi-iguytj; .?,&. Y \*> :.?.-<'.`Aur.ii S;Vv;o. .: * ' . 'vz-v* '-vy;* -r .. .. .... v .. t ' r- :c'=6! sic- ?- . " `u ' '' fejfiK - JWsWSHafeofc: $??' VYW%'^' ' V`r.' ' fi . ? ___ ~ . - , ........... '. G'-v!-A*'Wrt V !-, 'Z-tsei .-.- -.-ft'! -Sati}?-A;64sjtK-l; *c6*'*&m<s3 '* .. >< <<-" Environmentar-'rifM S- :r-:`.w Protection Ag Determination of Significant " - ... ^ v^X v' . */j ,+J-- * v;;.vG` zUv | r. # 1. v ?vt ftw * r:.*i _ ' ^ ::-rlT V :::;.;. . -* rr.^M: -- i: .V v. . jfi.fui <} sol/ .;.; t-n s. , ; - - ; - .ijt/virfi!'- y` KMX 01147 78970 Federal Register / Vol. 45, No. 230 / Wednesday, November 26,1980 / Proposed Rules . ENVIRONMENTAL PROTECTION procedures as a premanufacture notice toxicity of N-methanesulfonyl-p- 7 AGENCY r , (PMN) submitted under section toluenesulfonamide. .------- '5(a)(1)(A). In particular these Include the With regard to potential exposure, the 40 CFR Part 721 [OPTS-50013 FRL1558-1] information submittal requirements of .... Agency determined that exposure would section 5(d)(1) and section 5(b), the ' exemptions authorized by section 5(h), be relatively low taking into 7...... .. consideration the following information N-Methanesulfonyl-PToluenesulfonamide; Determination of Significant New Uses for a Chemical Substance , and the regulatory authorities of section supplied by National Starch and 5(e) and section 5(f). v^. v,: conclusions made regarding the " In this notice, EPA is proposing a . substance from the properties of close significant new use rule (SNURJyvhich . structural and use analogs: . . - - would apply to a particular chimical 4 V:#!.1Limited production volume: "'*"7 AGENCY: Environmental Protection substance for which a premanufacture ' between 400 and 600 pounds per year. Agency (EPA). notice (PMN) was submitted under VfV- 2. The substance is a crystalline sojid ACTION: Proposed rule. section 5(a)(1) of TSCA. This action is with a low vapor pressure. SUMMARY: EPA is proposing that certain uses of the chemical substance Nmethanesulfonyl-p-toluene sulfonamide be designated as "significant new uses" under section 5(a)(2) of the Toxic Substances Control Act (TSCA) (15 U.S.C. 2604). This substance was the subject of a premanufacture notice (PMN) submitted on September 5,1979 by National Starch and Chemical one of several approaches under TSCA 3. The substance is not likely to be to follow up on new chemical ". : . ' . metabolized by the body but rather will substances and to obtain additional > pass through the body in its original . data on selected Inventory substances. r state. ... 7.V-.. 4." - First, OPTS will continue to issue section 5(a)(2) significant new use rules - on a case-by-case basis for new ' . chemical substances of concern. Second, because use of the section 5(a)(2) and ' .other reporting authorities on a purely .. : 4. The substance is to be produced in ' probably two to three "batches" per 7 year, each production cycle requiring ' ' -less than 48 hours. .7 . ....' 5. Approximately five to six workers -; would be exposed to the substance during manufacture and processing. Corporation. Under Section 5(a)(1)(B) of case-by-case basis would impqse a 6. The substance would be used in TSCA, any person who intends to heavy burden on OPTS's limited . ` r low concentrations. '.'.. -7' manufacture, import or process the substance for a "significant new use" must submit a notice to EPA at least 90 resources. OPTS will develop model .: 7. The segment of the population using rules suitable for most situations when the substance is experienced in using ' ` follow up of new substances is " substances of this nature and thus. It days prior to manufacture, import or processing for. that. use. necessary. These model follow:up' riiles^ would know how to handle the material establishing general requirements and ^appropriately. - ....^,':77.y.; $ dates: Written comments should be submitted on or before January 12,1981. ADDRESS: Written comments should bear the document number OPTS 50013 and should be submitted in triplicate to the Document Control Officer, Office of Pesticides and Toxic Substances (TS- 793), Environmental Protection Agency, ~ Rm. E-447, 401 M St SW., Washington, ' DC20460. ` ''/ FOR FURTHER INFORMATION CONTACT: John B. Ritch, Jr,, Director, Industry Assistance Office (TS-799), Office of Pesticides and Toxic Substances. -, procedures, would allow EPA to ' promulgate rules more efficiently and " frequently than if it relied strictly upon case-by-case rulemaking. After the . development of model follow-up rules, case-by-case follow-up will be used when the model rules do not suffice. ' ,, Finally, in the future EPA will issue ^.significant new use rules on Inventory ; substances.or categories of substances. : PMN Substance of Concern: N. Methanesulfonyl-P-Toluenesulfonamide; PMN #5AHQ-0979-0016 ' On September 5,1979, National Starch 'T* 8. The product containing the ..substance carries instructions for porper handling and use. -- 7'!?&' . ` 9. The manner of application of the final product (confidential) is such as to minimize exposure. ^ -Tor the reasons stated ahoveTEPA determined that it was not necessary to ; regulate the substance for the use Sind... .exposure conditions described in the ;PMN. As a result EPA did not extend . the notice period, which expired on December 4,1979. National Starch has . been free to commence production since that time. The company submitted a ."Kf Environmental Protection Agency, Rm. and Chemical corporation ("National '' . Notice of Commencement of v ; ' E-429, 401 M St, SW,, Washington, DC 20460: toll free: (800-424-9065); in Starch") submitted a PMN for N- Manufacture, and the substance was methanesulfonyl-p-toluenesulfonamide. added to the Inventory during July 1980, Washington, D.C. (554-1404). According to information supplied by .published in the Federal Register of SUPPLEMENTARY INFORMATION: Section National Starch, the company intends,to August 26,1980 (45 FR 56909). Therefore, 5(a)(2) of the Toxic Substances Control manufacture annually approximately . until this rule becomes effective, the Act (TSCA) authorizes EPA to 400 pounds of the substance for the only substance may be produced without determine that a use of a chemical known use. National Starch claimed that . restrictions under TSCA. J:-: substance is a "significant new use." ~ this use of the chemical was confidential y " 'xr' - EPA must make this determination by a business information ("CBI"), and EPA EPA Concerns . - . r .... rule, promulgated after consideration of accepted this claim. When asked by EPA's decision not to regulate the all relevant factors, including those EPA for the maximum potential , substance under section 5(e) or 5(f) does enumerated in section 5(a)(2)(A) through production volume. National Starch ' ' not indicate a lack of concern about the (D). Once a use is determined to be a indicated that production would not . substance. In fact the Agency remains "significant new use," persons who exceed 1,000 pounds per year. ; concerned about this substance because intend to manufacture or process the During its assessment of the potential of the lack of any information or test substance for that use must, under risks associated with the substance, the data that would allow the Agency > section 5(a)(1)(B), submit a notice at Agency found that to the best of its reliably to determine or estimate its least 90 days proir to manufacture or knowledge no reliable toxicity data _ degree of toxicity. EPA does not processing for that use. The section 5(a)(1)(B) notice is subject to the same exists for the subject compound nor for... presume that this substance is. extremely any close structural analogs. Therefore toxic. Similarly, EPA is unable to - r..rt general statutory requirements and the Agency was unable to evaluate the conclude that it is not toxic. Rather, the KMX 01148 Federal Register / VoL 45, No. 230 / Wednesday. November 28. 1980 / Proposed Roles .78971 Agency has no knowledge aboot the significant new uses pursuant to section During the PMN review^mfdd, EPA ` >. substance's toxicity whatsoever. ' - ' 5(a)(2) of TSCA. In deciding what will did not evaluate any other qualitative EPA's concerns based on alack of constititnte a significant new use for a uses of the substance, because no other toxicity data were mitigated by the fact particular substance, the Agency will uses were claimed by the submitter. and that according to the information consider all relevant information about none were known to the Agency. ' , ' provided by the submitter, the " the actual or predicted toxicity of the However, now that this substance hail. probability and magnitude of exposure substance and (he exposures associated been added to the Inventory, there is a during manufacturing, processing, and with its proposed and potential uses. In possibility that new qualitative uses ; . use are relatively low. However, since ` this notice, EPA proposes to define each may develop which were not anticipated the substance is on the Inventory, any of the following as a significant new use by the submitter or EPA. Tbise new - person can make the substance under of this chemical substance; (1) qualitative uses may result hi exposures any conditions of manufacture, manufacture andprocessing of the ' which present new potential risks to processing, and use. Moreover, the PMN substance for any '`qualitative* use ' health and the environmehtlSSbsidmrlng submitter itself is not bound to the conditions specified in the PMN, and is free to change the use, volume, or manufacture of (he substance. ' (However, the submitter is bound at the time of submission to provide EPA the information required for a PMN, and any intentional falsification or withholding of required information could result in prosecution under 18 U.S.C. 1001 or appropriate enforcement action under TSCA.) In the absence of further action by EPA, the submitter or anyone else may produce the substance for any use without further notifying EPA. ' c EPA has no information to predict that uses, other than the use described in the other than that described in the PMN; (2) and manufacture or processing of more than 1,000pounds of the substance for the/use described in (lie PMN. These determinations of significant new uses are intended to apply to this chemical substance only, they do not establish a fixed policy with regard to the reporting triggers which may be utilized in future SNURs. The Agency's bases for each of these "significant new use" -' . determinations in this case are -- explained below. . : (1) Change in "Qualitative" Use ofthe Substance. EPA is proposing to require that any person intending to '` the factors set out in sectiotit(aX2) of TSCA. First, the new uses iayVemi!t in ' - a substantial increase in production _; volume. The volumes esthiatarl fe the' i . PMN for the third year bfj^eoifaction are' relatively low (400-600 ibe^isrid It Is' quite possible that a new qulQttfiye use' wiH require production hi excess these amounts. At a minimum, aj* significant increase in prbdu&tfca murid increase the exposures which'the, ' Agency anticipated in its PMNieriew of the substance. Second, a atwjjuafttative use may present new exposnre.problems not presented by the qpalj&ttye use assessed during the Agignc^.PMN -g* - 4 review of the aubstancfc SMfttdSgh only . PMN, will be developed or that such new qualitative uses will result in changes in exposure conditions. Further, in addition to new qualitative uses, there might be increases in production1' volume for the use described in the PMN, either by the submitter or by other manufacture or process the PMN substance for a "qualitative new use" submit a "significant new use" notice under $ 721.7. A "qualitative new use" is defined in proposed 1 721.3 as; the use of a substance, defined by its function " and particular commerickl or technical short term dermal exposure!! expected for the submitters intehriBdTqualitative. use, other qualitative uses mySlyfcg tlds . substance may result in higher. exposures; exposures bydififepent ^ routes, and exposures ijb^recur ibare v' m. companies. ' Hie risk that a substance presents to humans or the environment is a function of toxicity and exposure. In this case we know notiiing about toxicity, and anticipated exposures for the activities described in the PMN are relatively low. However, if.exposures increase in the future, the substance may present risks that cannot be evaluated (by either industry or EPA because there are no ! toxicity data. EPA has a responsibility to evaluate any risks that might result in the event that this substance is toxic. In particular, EPA believes that consistent with the purposes of TSCA section 5, if exposures increase for this substance, the Agency should either review any application, without regard to the quantity of a substance for that use. ' EPA has determined that such - qualitative new uses ire significant because they could present a potential ` for risk based npon the unknown ' toxicity of the substance and the new or additional exposures which would be associated with new qualitative uses. Submittal of a significant new use notice would provide the Agency with an opportunity to examine proposed new qualitative uses of this substance, and deckle if action should be taken under TSCA section 5 to prohibit the . manufacturing and/or processing of the substance for this use. Such changes in exposure slfiild occur if r a new qualitative use rfgyjmbatimcR resulted in changes in the (banner and ^ methods of manu&cttBt^'p^pceefing, distribution in commerce,riaerand': {`jtf ' disposal. In sum, onecraoenaf the * ' changes in exposure which could result - from the new nse would result in both the chemical industry andEPA needing to know mare about the substance's T toxicity to adequately evaluate risks and make informed Judgments about the need to take control actums.* As indicated, the proposal would require manufacturers and processors to submit a PMN notice for any qualitative new use. The Agency recognizes that ' . additional toxicity data which may have As discussed above, EPA has this requirement may remit hi the" "J?'? been developed for this substance or evaluated the potential exposures to the submittal of a PMN notice for new 'v analogous substances, or consider PMN substance which would result from qualitative use which the Agency may whether the substance should be the qualitative use intended by the conclude presents less risk than the controlled until toxicity data are submitter, and the exposures which National Starch qualitative use. The developed. To accomplish this purpose, would occur during manufacture of the Agency, however, was unable to devise EPA proposes to designate as substance by the submitter. The Agency a formula which would identify "significant new uses" certain uses of determined that these exposures would adequately any such new qualitative ' this substance that would Tesult in new be relatively low. Based upon this uses and exclude them from the PMN * or increased exposures. assessment, EPA decided during the submittal requirement The Ag'ency was Proposed Significant New Uses PMN review period that regulatory action was not warranted at that time, unable to do so because the toxicity of the PMN substance ti tfhh&owh and ~ EPA believes that in general, there are although the Agency knew nothing unpredictable, andbecause'(he a variety of different ways to define about the toxicity of the substance. Agency's decision not to abt on the KMX 01149 78972 Federal Register / Vol. 45, No. 230 / Wednesday, November 26, 1980 / Proposed Rules ' National Starch PMN involved - significant new use determination, the judgments which could not be reduced . legislative history indicates that a to a formula. The Agency expressly change in a single factor could be solicits comment on whether such a enough. In this regard, the Conference ' formula can be devised, including any Report stated that "a significant suggestions for "cut off" formulas which increase in the projected volume * * *, commentors believe will adequately a significant change in the type or form accomplish the Agency's objectives. . of human exposure * * *, or a However, the Agency notes that the significant increase in the consequences of having no "cut off" magnitude * * * could be the basis for formula are less severe than the ' determining that a use is a significant consequences of an inadequate cut-off new use." 1 Finally, use of production formula--the entrance on the market ; volume in this manner is consistent with place of new qualitative uses posing significant risk concerns without the intent of section 5(a)(2), because and increase in volume usually will correlate necessary Agency review. If the Agency with increased exposure to humans or is correct that an adequate cut-off .. . - \ . the environment, and increased formula cannot be devised, it has no doubt that it has authority to impose a broad PMN. reporting requirement such as the one included in the proposal. To : .' exposure is the primary consideration in making a finding of a'"significant new use." Especially where there is no information about toxicity, as in this conclude otherwise would effectively case. exposure factors such as prevent the Agency from imposing PMN production volume are the focus of requirements on new qualitative uses in EPA's SNUR decisionmaking. cases where industry failure to develop With regard to this substance, the sufficient data have prevented the PMN-submitter's intended use will result Agency from developing a "cut off" , in some exposure to workers at the formula. Congress intended industry to projected production volumes. An bear the burden of developing data to increase in the quantity manufactured access TSCA chemicals, not the Agency. for this particular use very likely will An implicit corollary of the TSCA _ increase either the number of workers burden of proof concept is that the exposed to the substance in the final, industry--and not the Agency and the product at the same level, or the total public-bear the consequences of failing numbers of hours the product is used, _ to meet this burden. . resulting in greater frequency of . ' (2) Increase in Volume ofProduction for the Use Described in the PMN. EPA . proposes to designate production by any one person of more than 1,000 pounds of the substance per year for use in the ., .manner described in the PMN as a "significant new use" of the substance. In die PMN, the submitter stated that he would manufacture a total of .... approximately 400 to 600 pounds per exposure to the present number of persons. In either case, it is reasonable to anticipate that there would be increased exposure of humans to the substance. ..Cri' >' - - An expansion in production volume for this use may increase exposure in another way. Conditions of manufacture and processing of the substance could change if production volume expands significantly. This is because the initial year of the substance by the third year. The submitter subsequently indicated to production equipment arid processes may not, for technical and economic EPA that 1,000 pounds per year was its most optimistic estimate of total production for any year. Therefore, reasons, be the best ones for producing the substance in higher volumes. Thus, if these changes occur in how the because it would be approximately substance is produced and handled, the ' twice the submitter's best third-year types and levels of exposure also may projection and would exceed his most change, including possible increases in optimistic long-run production estimate, exposure. - (S' " production of over 1,000 pounds in any . Not all increases in'production one year would represent a significant volume are "significant" from the expansion in volume. . , standpoint of increased exposures. Also, Congress intended production volume, it is impossible to predict in quantitative to be a major factor in the determination terms the specific changes in exposure of what is a significant new use for a that will result from increased substance. Projected volume of production. Generally, it may not be manufacture and processing is one of appropriate to require submission of the relevant factors listed in section SNUR notices to EPA for marginal 5(a)(2) that EPA must consider in changes in volume. Rather, the notices making its findings that a use is a should reflect "significant" changes, and "significant new" use. Further, while . one measure of "significance" is the section 5(a)(2) states that all relevant ' factors are to be considered in making a ' HR. Rep. 94-1679. 94th Cohg., 2d Sees. 66. submitter's own estimates of production volume. Presumably, maximum or J*?. "outside" estimates represent the . X submitter's own best estimates of '--p? potential market demand, and thus .U production volume, for the new ._ substance. Anything exceeding this would be unanticipated by the submitter in making his technical, commercial, and industrial hygiene plans, i.e.it would be "significant" to him in several respects. If it also could lead to significant new ... exposures, then it may be the basis for.a. finding of a "significant new use,":. -v:.v- partfcularly when there is no,^ XSf&n w information about toxicity. . Z-ifSjrf-*.. ' In this case, the submitter's ultimate . production estimate of 1,000 pounds per year is a maximum figure--a range of 400 to 600 pounds is projected as being realistic and most probably for the third year. To allow for moderate increases in volume consistent with the. . ; manufacturer's own plans for production and commercialization; EPA proposes to use the 1,000 pound figure as a basis for a finding that a significant change in production occurs. As noted above, in' . this case increase in production.will 7" likely correlate with increase\ exposure, so that the selectioriof the 1,000 pound figure accounts both for the normal growth of the product.and ,. . increased risks to humans. EPA proposes that this 1,000 pounds per year amount be applied on a per- '. person basis--that is, under thexxXx proposed SNUR more than l.ODOpounds of the substance could be produced, if several companies manufacture the,,. ar substance, each making no morejthan 1,000 pounds per year. The Agency - 4 considered making the 1,000 pounds figure an aggregate one, so that total U.S. poduction in any one year could not exceed 1,000 pounds without ''`W's'-. notification to EPA. However, EPA.is not proposing this requiremerit for three reasons: ' ' 1. To implement such a rule EPA ... -; might need to develop some type of .. "allocation" or "rationing" systeiri,' " requiring some manufacturers to submit a notice based on the cumulative production of the substance bya-X number of different persons. Although such an approach may be appropriate for some production volume SNURs, it is neither necessary nor appropriate to do so here, particularly in light of the next two points. .: . 2. Based upon information gathered during EPA's review of the PMN It is likely that this company will be the only producer of the PMN substance fot his use. . . , . :. .v'-KX'.',. . 3. The other proposed SNUR 1 "trigger"--requiring a notice prior to ' manufacture for any other qualitative KMX 01150 ; *; I1 Federal Register / Vol 45, - No. 230 / Wednesday, November 28, 1980 / Proposed Rales .78973 use--provides assurance that other year average may pose some difficulty several does not significantly'affect total c possible exposures will not occur - in enforcement actions. EPA requests exposure. EPA requests comment on " . without poor notice to EPA. By taking a - comment on these problems, and the whether the 1,000 pound trigger should - comprehensive approach to this SNUR. overall utility of die two-year average in be applied to processors as indirect -,p ' in terms of the possible exposures that cases like this one. ,. means of limiting aggregate manufacture' are covered, EPA can set production Persons Subject To Section 5(a)(1)(B) of the substance. volume limits at the maximum levels projected by the PMN submitter and still Section 5(a)(1)(B) states that no Required Information ... ensure that significant mcreases in person shall manufacture or process a As indicated in $ 72X7, EPA is not hi I""' exposure will not take place before EPA substance for a significant new use ~ this time proposing any noticejfana has reviewed them. Under the proposed unless that person submits a notice in other special information requirements ' - rule, a person would be required to accordance with section 5(a). This . for notices submitted under this Part. .._ sumbit a notice at least 90 days before suggests that any significant new use - Instead, the Agency is prppqsia&tha^;.! manufacturing or processing the rule applies automatically to both any such notices comply with the ' substance for the significant new use. In manufacturers and processors. explicit requirements ofeectiqn<5 of the caseof the production volume ' - However, EPA does not interpret this TSCA. In particular. Ihislncltides theT ' . trigger, this would mean the notice must provision in this manner instead, the requirement to submit thejnfanniation ; t': be filed at least 90 days prior to the point when the 1J000 pound trigger - >- Agency believes that it bas authority to J and data described in actijmJtiJM- :r v.. and should adjust the coverage of S; vEPA's policy with regard lo ujfctt) tostw would be exceeded and the 14)00 pound manufacturers and processors in the level could not be exceeded until the -rule in order to eliminate duplication, or other health and safety daia'fi, person.^; should include in a noticeji|dihcuased" . SNUR notice period expired. reduce unnecessary burdens, where it - in the next section at rids notice; other In EPA's proposed rule, the " ' calculation of when a person would exceed the 14X30 pound level is made for each calendar year on an individual basis, without regard to the'production far previous years. However, EPA is also considering substituting a moving two-year average for the calculation made on a year-by-year basis. Under this method a person would average his production for the current year with that of die previous year, and would only be has a reasonable basis for doing so. In this case, EPA is proposing that both manufacturers and processors be required to give notice of significant new uses as defined in proposed - { 721.75(a), that is, for qualitative new '' . uses. Both manufacturers and .' .processors are capable of initiating, - > either singly or in concert, the actions ' which may result in si^prificant new exposures in conjunction with - ;. manufacturing or processing the ' - : substances for qualitative new uses. For issues concerning mfoa&atio& submittal, requirements under section 5(d)(1) are discussed immediately EPA previously'has proppaedform*. ~ and other requirements^mcb iiSlbe . .. applicable to notices far^y,Cfajmic*l ^ . substances, submitted under ' 5{a}{lKA} published . Register of January 1418?) (44 64572), reproposed in.tte'Ejjdetal ' Register of October 14 UMjjff 59764). EPA at this tiBteT^Apropqstng similar detailed rules for apace* * ' , ; . -w ; _ .> ' subject to the porting"requirement at example, 2 a person manufactures the ' significant new usesfotjj^erttlre&sons.' ' least 90 days prior to the time when the substance, and sells it to a person who c The Agency, still befiamj^t.fpnms . average of the current year and the ' processes it for a qualitative new use, ~ and rules for reporting uhtw section 5^ly. preceding year exceed 1,000 pounds. For increased exposures may result from the are useful andnecessary,]the long example, a person could produce 1,500 independent actions ofeither the -7; run. EPA has been re<?^(M WdN's far . . u pounds of the substance in 1983 if his manufacturer or processor at their ' new chemical substano^imiice juty 197B production had been 500 pounds or less respective stages of the chemical's life under an Interim Poliqy pabfished in Ike 1 - in 1982. . ' ' : *" . cycle. In this case, the reporting ' Federal Register of May,l!f2979 (44 FR.; Use of a two-year average might more responsibility should fall on both , 28564). Experience under^ms ^policy. .' . closely.approximate the realities of persons, who may submit either ... which among other thingsstated that the production of low-volume specialty separate notices reflecting forthcoming PMNs should include information and . chemicals. Fluctuations in annual changed exposures at each stage, or a data required by thelaw'bjubeen ...ti production levels that result in an combined notice reflecting ail stages of mixed. A few notices have Seen quite" occasionally very high or very low the substance's life-cycle. complete; others, while meeting the . annual figure seem to be common. Thus, EPA is proposing that only the statutory minimums. have b,een so brief depending on inventory levels, cost and persons who intend to manufacture in and informative as to haiqper EPA's ; availability of feedstocks, or availability excess of 1,000 pounds per annum of the initial review, although in almost all '. * of production equipment a single year's substance for the use proposed in the cases the submitters later were willing production can be much greater or less PMN be required to submit a notice. to supplement the PMN to some degree than previous or succeeding years. Under this proposal, it would In response to specific questions posed However, such changes may not signal theoretically be possible for a single by the Agency. In short the "past few significant growth. person to process more than 1.000 months have generally reinforced EPA's .' EPA can foresee two possible pounds of the substance for the original view that an efficient and -:;.x : ' disadvantages to a production volume originally proposed use without effective section 5 prenuauriacture " trigger based on a two-year moving notifying EPA. He could do this by notification review program, especially 1 t t average. First some significant growth scenarios would be identified only one year after the growth had actually purchasing the substance from two or mare different manufacturers, each of whom manufactured less than the 1,000 one that may have to process a ::.:p significantly greater number of notices than ifhas in this early phase, needs exceeded the 1,000 pound level. For pounds which would trigger significant rules and forms to standardize the ` example, if production equalled 200 new use reporting. However, this submittal of information. Inline with pounds in 1981, and 1,700 pounds in 1982 eventuality is unlikely; in addition, once this determination, EPA is continuing ~ as part of planned significant growth, a given amount of the substance has with efforts to develop afumi or forma --- . EPA might not receive a notice until been manufactured, the fact that .. for significant new use notification, as - i 1983. A second concern is that a two- processing occurs at one site rather than one of the many facets iff developing ~ - _'_. , KMX 01151 78974 Federal Register / Vol. 45, No. 230 / Wednesday, November 28. 1980 / Proposed Rules ' general rules and procedures for : "follow-up" of new chemical - substances. When these rules are proposed, the Agency also will propose ' that the information requirements extend to any significant new use rules for individual substances which are in effect at that time. However. EPA will not be prepared to propose these rules until 1981. EPA believes that, with an exhaustive examination of significant new use information requirements pending, it is not necessary or useful to devote 1,: resources to a detailed consideration of these requirements in the context of a SNUR for a single chemical substance. The number of notices likely to be ; submitted under this rule should be rather low, and therefore assessing notices which are not in a standard format, or which EPA must request the submitter to supplement to some degree, should not constitute a serious burden on the program. . .. Pending development of detailed reporting rules for notices submitted under SNURs, EPA believes persons should submit notices on the basis of EPA's Interim Policy for Premanufacture Notices published in the Federal Register of May 15,1979 (44 FR 28564). Although the Interim Policy document was not drafted specifically to include significant nevy use notices, EPA has " reviewed the Interim Policy and - determined that, the guidance it provides is generally applicable. However, for the purposes of this proposed SNUR, EPA is supplementing the Interim Policy with the following additional guidance. - First, persons would not be required to submit information and data that were included in the original PMN. For example, if a person submits a SNUR notice because he intends to manufacture 2,000 pounds of the - substance for the use described in the PMN, he would focus on the volume increase and need not provide further deatiled descriptions of the use. However, to the extent that the estimated exposures differed significantly from those in the PMN, this information must be corrected and updated. ' ? ; Second. EPA would urge persons to submit more specific and detailed information on the human exposures and environmental release that result from any significant new use of the substance. Information on these topics will allow EPA to focus on these new uses at a level of detail consistent with its conclusion that they are "significant." . EPA requests comments on additional guidance which the Agency should provide when this rule is promulgated. Health and Safety Studies In addition to submitting information required by section 5(d)(1)(B) and (C) of the-Act concerning the submittal of data related to health and environmental effects, these sections require the submittal of health and environmental effects data that are known to or . reasonably ascertainable by the ..... submitter but do not require the . submitter to perform additional testing. EPA has proposed its interpretation of these requirements under proposed 40 CFR 720.23 published in the Federal Register January 10,1979 (44 FR 2270), and the Agency's final rules on this subject would apply to any section . 5(a)(1)(B) notices submitted under this SNUR. ut~gs4T_-`'tr.44' Any notice submitted under this rule would describe a proposed use of this substance that involves signficant . exposure to humans or the environment. As discussed above, at this time EPA is unable to conclude anything about the .. substance's toxic properties, and this lack of information is one of the reasons for issuing this SNUR. If exposures . change or increase, so will possible ... risks, and it is this possibility that is the basis for EPA's concerns about ... production and use of the chemical. _ Because of these potential-risks from the increased exposures indicated by the proposed SNUR triggers, EPA .;:, strongly encourages any person who submits a notice under this SNUR to include information on the substance's toxic properties. EPA is planning to publish premanufacture testing guidance in the near future. Persons subject to this SNUR are urged to refer to the testing guidance for EPA's recommendations concerning data needed for assessment of risk presented by new chemicals or significant new uses of existing chemicals. Procedures for Filing SNUR Notices EPA is not in this notice, proposing any procedures for the processing of notices which may be submitted under this rule. Instead, the proposed rule focuses only on the most essential elements of this SNUR, including definition of significant new uses, description of types of persons subject to the requirements, and special exemption procedures. As discussed above, EPA has begun to develop general rules on the subject of "follow up," under the authorities of section 5(a)(2) and section 8(a). This rulemaking will parallel the initial PMN rulemaking, addressing any overall procedural . issues in the implementation of SNUR requirements and review of notices. When these rules are proposed, EPA will indicate that certain portions of / ' them--including information requirements, disposition procedures, ' etc.--would apply to any SNURs 'Si; * promulgated on a case-by-case basis ` prior to the effective date of the general follow-up rules. (The general rules ' would also-apply to subsequent case-by.- case significant new use rules unless the individual rule specifically stated otherwise.) - .x-.-.r-e Pending completion of that .. x rulemaking, persons submitting SNUR ... notices should rely on EPA's Interim Policy for guidance. Thecpresent PMN Interim Policy (44 FR 28564) addresses a variety of topics including submitter^ identification, notice certification, ",; section 5(d)(2) Federal Register notices and procedures for asserting confidentiality claims. EPA is . ,, considering supplementing and 'Ti modifying this policy, based on ' experience with PMNs.thus far. EPA requests comments on any special r> procedures that should be. developed for significant new use notices., '- y^. Procedures for Informing lPefsons of lhe Existence,of This SigniflcanfNew Use" Rule One practical problem that EPA must confront in implementing.this proposed' rule is the task of informing'persons That certain uses of the substance are subject to a significant new use ruleT.jC_'.. discussion of the Agency(s'proposed . methods follows. EPA requests .'. suggestions for additions! methods of .. disseminating this information. EPA will follow the foBnal.".',^'^^- mechanisms for notice that anew regulation has come into effect. First, the .final rule will be published in the v Federal Register. Second, because the rule is one of continuing applicability and effect, it will be codified in Title 40 of Code of Federal Regulations (CFR), which is revised annually. ;> In addition to these formal notice ' mechanisms. EPA is exploring the " possibility of using the Inventory of existing chemical substances or . associated documents to inform persons of'the existence of this SNUR, The Agency contemplates placing a footnote on the Inventory by the chemical " identity of this substance. This footnote could refer the user to a statement that the substance was subject to a SNUR; this would notify the person of the ' requirement, and lead him to contact EPA for further information. In the >v* alternative, the footnote could refer the user to an Inventory Appendix which would give a Federal Register or CFR citation of the rule. ' EPA believes that use of the Inventory in this manner would be an effective KMX 01152 ' r - . Federal Register / Vol. 45, No. 230 / Wednesday, November 28, 1980 / Proposed J8975 way of informing persons about the rule. requester indicates that he hSa a bona '-ll ' similar to premanufssjjire,notices for Any person who intends to manufacture fide intent to manufacture or process the new chemical substanoe, When a notice a substance which he has not - substance for that purpose. The is received, EPA willjiublish a summary manufactured before should check the proposed rule sets out the information in the Federal Register in, accordance Inventory to determine if the substance EPA would require a person to submit in with 5(d)(2). The revi^wjperiod for the . is listed, in order to determine whether order to establish bona fide intent Use notice will run 90 days lrom,EPA receipt or not to file a PMN for a new chemical of this procedure will prevent fishing of the notice; under section 5(c) this - substance. If he does find the substance expeditions by competitors, while period may be extended up to an on the Inventory, but it is subject to a allowing persons with legitimate additional 90 days for^gqod cause." The SNUR, he will be put on notice of this intentions to determine whether a ' . submitter may not manufacture or . fact, and can take further-actions to section 5(a)(1)(B) notice is required. On process the substance_fojthe significant determine whether he would be subject the other hand use of such an approach new use until the nadewpfldod. 'I to the section 5(a)(1)(B) reporting does moderately increase the burden on including extensions, & expired. As - requirement . . persons intending to manufacture or . with a PMN for a neWchnnlcal Finally, to help ensure that all persons process the substance. This approach substance, EPA wiUusemahqticeaVa potentially subject to the rule are put on for responding to inquiries concerning point of departure for asMssment,^ fl - .notice, EPA is considering imposing on qse description is similar to the ;:n supplementing the the original manufacturer the duty of procedure utilized in the Inventory Rules submitted with it wjthb^gJ^avaflabie^ . informing persons purchasing the (40 CFR 710.7(g)) to enable EPA to ' ' data to the extent necesaanTandv`V:`.,' substance from him of the existence of ' respond to bona ,^'de inquiries ... -piMaible. ' the significant new use rule. The ' concerning the identities of confidential The Agency has a variety of means of requirement to give notice could also be substances on the Inventory. ", ' addressing concems^raised bysuch a extended to other situationsin which EPA examined the alternative of using notice. Section 5(e) specm&ilyprovides the original manufacturer becomes the authorities of section 14(a) to for EPA to regulate the substance^under aware that another person intends to disclose the proposed use of the . ' certain conditions, penaiggThe"t ' " manufacture, process, or use the substance for the purposes of this ' development of informal substance-- especially situations in rulemaking and in the final rule itself. . to evaluate the healffijm which the original manufacturer has a The Agency believfes such a disclosure environmental effects^ ^substance. . commercial interest in the new use, as in . could be based on the authprity of ' . In addition, sections^ sale of production rights or production section 14(a)(4), which states that *"' ' authority'for EPA to.cj Oj exposures . technology. . - T-. . .. ' otherwise confidential information "may which result in an jimt priableris^to EPA authority to impose such a ' be disclosed when relevant in any ' . ` health or the envir6'nmS_ imay^'; requirement would be based on the . ~ .-proceeding" under the Act. This 1 ', ` also refer the information JierEPA terms of the SNUR, which make it rulemaking is clearly'such a ' : . " offices and otherFeda'"* aciesTlf' unlawful to manufacture or process a . ^proceeding" arid the qualitative use 1 [ these offices would! substance for a significant new use as description, an essential part of the rule, evaluating new uses'! - defined by the Agency. Inherent in this is clearly "relevant." However, EPA is 'substances and corifrolL S.fKem when requirement is the responsibility of a not proposing to disclose specific use appropriate, manufacturer or processor to know information in this case. Section 14(a)(4) -Section 5(g) is theft! [[ofTectibn something about the uses being made of qualifies the Agency's rights to disclose 5 which mandates spra eatment Bf a substance, or at least to inform by stating that disclosure "shall be 'f SNUR notices. This pro Ion stales ' persons for whom the substance is being made in such manner as to preserve ' ' that, at the'end of thenofi ationpeflbd manufactured or processed that certain confidentiality to the extent practicable for a significant new use,*! R.A .must ' ' . uses are subject to a SNUR. _ without impairing the proceeding." ' publish in the Federal Register a ` ' ^ ^ Confidentiality ofProposed Use In its PMN, the manufacturer asserted a claim of confidentiality with respect to the qualitative use of the new chemical substance, and EPA has acquiesced in this claim. The confidentiality of the use poses significant problems for the implementation of this rule, in which significant new uses of the substance are at least partially defined by the use ' proposed in the PMN. EPA's proposed resolution of the problem, and alternative approaches which were considered are discussed below. EPA is proposing that the confidential description of the use not be published in the final rule, 721.75. Instead, under 721.11 of the proposal, a person who intends to manufacture or process the substance (the chemical identity of which is not confidential) for any use EPA's tentative conclusion is that, because the identity of the substance is not confidential, maintaining - confidentiality in this case except where bona fide intent to manufacture is ^ - shown may not unduly hamper the ability of persons to participate in this rulemaking or to comply with the rule when promulgated. This determination, however, is based on the facts of this particular case; the Agency is not ' proposing a general policy of maintaining confidentiality for essential elements of section 5 rulemaking, and believes that on different facts section 14(a)(4) would justify broader disclosure. EPA specifically requests comments on how it should handle confidentiality issues in this and future SNURs. EPA Review ofNotice _.'......... . statement of the reasonsTor not initiating an action'undjjrse'ctioh 8 or . section 7 to control tKe subsfhnce. EPA has not determined the'[appropriate --' '' contents or level of dbtafi for. this notice, ' and requests public comment on the ' ^ purposes this notice"should serve. " ' . Modification ofReportingRequirement Based on Notices - EPA is not propdsingfiMffi3oes riot' ,l' believe it would be appropriate to ; proposed, a sunset provision that would terminate, on the basis of passage of time alone, the signficant new use ' ' reporting requirement On,the other hand, the Agency believes that there may be several circumstances, arising from the submittal of notices, which will bmjtted . may ask EPA if that use is the same as ' EPA intends to process and review which describes a significant new use, the existing one. However, EPA will any section 5(a)(1)(B) notices submitted EPA will be able to review the use to provide this information only if the under this proposed rule in a manner determine whether any control KMX 01153 i 78976 Federal Register / Vol. 45, No. 230 / Wednesday, November 26, 1980 / .Proposed Rules ' 'v;' AU- measures are necessary. Once the Cost Analysis - and (f) of TSCA. These uncertainties ^. Agency has had its review opportunity, the use reported would arguably not be "new" any longer, and EPA believes that in general, the requirement to submit PMNs for such specific new uses should be lifted once the submitter begins to manufacture or process for that particular use. In these cases, the Agency proposes that the significant new use rule itself be modified or annotated automatically--that is, without following rulemaking procedures. The justification for such an approach is simple. Addition of a particular use to a fist of existing uses would not be a discretionary activity. Rather, it would be akin to the ; automatic addition to the Inventory of a new chemical substance upon EPA's receipt of a Notice of Commencement of Manufacture. This would mean essentially that for each substance subject to a SNUR there would be a list of uses not subject to the SNUR which EPA would supplement automatically as new uses were reviewed, unless EPA acted to prohibit die. use. However, . establishing a list of non-SNUR uses may not be necessary in all cases, ' depending on how the reporting triggers are defined.. . ' ';'v ' ;i; " - -While the Agency would hot have ; discretion tojrevent a new use from being added to the fist of "existing" ' uses, in some cases it might want.to propose that certain changes in that use themselves be considered as significant. According to the manufacturer of the PMN chemical, its production (or processing] of the PMN chemical is not expected to exceed the "trigger" level stated in the SNUR. Therefore, the may afreet the total market for the PMN ^ chemical. While the Agency C? acknowledges that these indirect costs'; may exist, it also realizes that ft is extremely difficult (Ifnot impossible) to manufacturer is not required to do estimate the extent of these boats and . , ' anything at this time, and should not ' incur any direct costs as a result of this ` SNUR. .. ' ' ' their p* ossible impacts at f'ills time. ~ ' '`'!'v' Rulemaking Record J 'r- However, in the event that production The following documents constitute^ (or processing) of the chemical is the administrative recordoffhia rule . intended to exceed the "trigger" level, (docket number OPTS 50013jjExcepto* ' then the manufacturer or processor will the extent that confidential business ' be required to submit the information -information has been maskwL&ll :_,J$ included in section 5(d)(1) in accordance documents are available tqjtbj^jiublic in ' with EPA's Interim PMN Policy. The ' cost of submitting a notice under EPA's Interim'Policy has not been determined. However, the Agency did propose a PMN form in October 1979, and the cost offilling out and submitting that farm was estimated to range from $1,155 to $8,900. EPA believes the cost of submitting a notice under the Interim Policy has in most cases been in the . the OPTS Reading Room. fl^aam.to . 4:00 p.m. Monday through Friday, except _ - legal holidays, Room E-447,4CH M St, SW, Washington, D.C. 20480, This record includes baric information '' '"*)'%/ considered by the Agency In'developing ~ the proposed rule. EPA will supplement' the record with additional information ' - as it is received. The recordintrudes the lower part of this range. . - ; - following categories of infmmuq'fiim; ; ' The cost estimate for completing the ` 11 The PMN submitted by^ati^nsj, revised PMN'form cited above did not Starch, and other gupplemeatary written v include the cost for asserting and . materials."J / substantiating mnfiA>iitility rlaim. 2. The Federal Register notice of ' 'Hie costs for claiming and " - ... . , receipt of the PMN. substantiating confidentiality claims on 3. Records of all communications and EPA's proposed farm estimated by . j ; meetings between EPA pereb&el and EPA's contractor ranged from $900- , ; ft National Starch. $8,400. Although EPA has not prepared an assessment of the cost PMN -. submitters have actually been incurring '4. 'Any factual infarmatirani?tne Agency considered m developing thiferule. " '* . For example. EPA might not be - . in asserting and substantiating .. ' 5. Comments received onjfius notice. - concerned if a person proposed to manufacture 1^500 pounds of the confidentiality claims under the Interim . EPA will identify the complete . ; $ - . Policy far PMNs. EPA believes it has rulemaking record on or before the date . " . substance for qualitative new use X, but might wish to review the use in the future if the total production rose to 10.000 pounds, or if some aspect of that use changed. The requirement to report these changes could result from a narrow description of the qualitative use added to the existing use list, e.g., been only a small percentage of the . costs estimated for the Agency's . October 16,1979 reproposed form. . EPA has not estimated the costs a submitter might incur in developing test or other data on the substance subject to SNUR notice. Although the SNUR does not require that the person perform of promulgation, as prescribed by...... ,i, ^ section 19(a)(3) of TSCA. and will accept additional materials for. inclusion - in the record at any time between this' . notice and that designation. final ' ' rule will also permit persons lo pcnnt out any errors or omissions'in file record. 1 . ...... "manufacture of 1,500 lbs. for qualitative additional testing EPA expects that Regulatory Analysis , ....... use X." In other cases, further rulemaking under section 5(a)(2) might be appropriate. In addition to modifying the SNUR, EPA may follow up on particular new uses in other ways, including issuance of section 8 reporting some level of additional information, which may include testing will be generated. However, it is impossible for EPA to estimate the level of costs which may result. . The cost also does not include any EPA has determined that this ' document does not contain e proposal! ' for which the Agency is required to _ ' conduct aHegulatory Analysis under " Executive Order 12044. . ^ ; -s': - rules. ' - Of course, submittal of a section 5 notice for a significant new use may result in a more substantial modification indirect costs that may result from the imposition of the SNUR. These indirect costs may result from business decisions against the use of the PMN chemical due Regulatorry. D.evelopme nt EPA has determined that the proposal contained in this document is a .... of the significant new use rule. If, for to increased uncertainties about the specialized regulation. Specialized example, a notice contains information economic viability of the chemical for regulations are not subject to the ' i' sufficient to show that a substance is of levels of production (or processing) procedural requirements of E.O. 12044, very low toxicity, the class of exceeding the trigger level, and the and are not subject to the uniform "significant" new uses subject to uncertainty of using a chemical that may regulation development procedures ' reporting may be nanowed to very high be subject to future Agency promulgated by EPA and published in exposure situations, or eliminated requirements, i.e., testing requirements the Federal Register of May 29,1979 (44 entirely. or regulatory controls, under section 5(e) fr 30988). - KMX 01154 Federal Register / Vol. 45, No. 230 / Wednesday, November 26, 1980 / Proposed Rules 78??7 Dated: November 18.1980. .. territory of the U.S. consists of the 50 Part for any significant new use, of.that ' Douglas M. Costle, states. Puerto Rico, and the District of substance specified in Subpart Bof this_ Administrator. . It is proposed that a new Part 721 be added to Chapter I of Title 40 as follows: Columbia. (c) "Manufacture for commercial purposes" means to import, produce, or manufacture with the purpose of Part. . - .-2sjR4sr^t|psL*^'-, . (2) Any person who intends to import if into the United States for commercial '--/ / purposes, other than as part ofan PART 721--SIGNIFICANT NEW CHEMICAL USE Subpart A--General Provisions obtaining an immediate or eventual commercial advantage for the manufacturer and include(s), among other things, such "manufacture" of any article, any chemical substance listedjp..! Subpart B of this Part for anyslgflificaht^ ' new use.of that substance spedfied in.,.^^/ Subpart B of this Part Sec. amount of a chemcial substance or 721.1 Scope. mixture: . - / '. ' 721.3 Definitions. - (1) For commercial distribution, 721.S Persons who must report including for test marketing. 721.7 Notice requirements and procedures. (2) For use by the manufacturer 721.11 Information for persons - demonstrating a bona fide intent to manufacture, import or process. ' 721.15 Exemptions and exclusions. . _ .. including use for product research and />-.:. ./development, or -Manufacture for as an intermediate. commercial purposes - also applies to substances that are Subpart B--New Uses for Specific Chemical produced coincidentally during the Substances manufacture, processing, use, or 721.175 N-methanesulfonyl-ptoluenesulfonamide. , . disposal of another substance or ,, - - mixture, including both byproducts that Authority: Sec. 5 of the Toxic Substances Control Act, Public Law 94-469 (90 Stat. 2003 (15 U.S.C. 2601 et seq.)). are separated from that other substance or mixture. Such byproducts and impurities may, or may not in Subpart A--General Provisions themselves have commercial value. They are nonetheless produced for the 721.1 Scope. , .. - purpose of obtaining a commercial ,, This Part identifies activities with ~ advantage since they are part of the* respect to certain chemical substances. - manufacture of a chemcial product for a (3) Any person who intends to process- in die United States for commercial -purposes any substancelisted In Subpart B of this Part for anyslgnificant?. . r new use of that substancii spdclfied'lri- -v Subpart B of this Part iI . (b) [Reserved] ' ' 721.7 Notice requlrements'and ' procedures. '*13 ?as*U.-wdia^iiiSlatSBwSC' . Each person who'is reijuKirtcfsulmiit . a significant new use noticgunder .this;* Part must submit the noticftAtJeast 90 ;/ calendar days before commencing an 5 . . activity specified in 721.5 withjespect , to that use. The submitterbiusT&mply^...... with any applicable require*^ section 5(b) of TSCA, andJ, the information and data\sp section 5(d)(1). " which EPA has determined are . "significant new uses" under the v authority of section 5(a)(2) of the Toxic Substances Control Act (TSCA). In - . commercial purpose. `' (d) "Qualitative use-" means the use of a substance, defined by its function and /particular commercial or technical . 721.11 Information tor persons' demonstrating a bona fidalntehito ' . manufacture, Import, or /' (a) If an impoiianffac^^SiJ^:^'*^b>j.; ; addition, it specifies the persons subject ' application, without regard to the to the reporting requirements, c ^ > quantity of the substance for that use. procedures for exclusions in certain ((e) "Person" means any natural cases, and the information to be reported in a notice. . * . person, firm, company, corporation, joint venture, partnership, sole proprietorship, association, or any other business 721.3 Definitions. : - ' entity, arid State or political subdivision The definitions in section 3 of TSCA, thereof, any municipality, and interstate 15 U.S.C section 2602, apply for this body, and any department, agency, or rule. In addition, the following terms are instrumentality of the Federal defined: . ,- Government. ' (a) "EPA" means the U.S. ' .. (f) "Process for commercial purposes" Environmental Protection Agency. means the preparation of a chemical (b) "Importer" or "person who intends substance or mixture, after its to import" means anyone who intends to manufacture, for distribution in - import any chemical substance, in pure commerce with the purpose of obtaining form or as part of a mixture or article, an immediate or eventual commercial into the customs territory of the U.S. and advantage for the processor. Processing includes: ' ' any amount of a chemical substance or (1) The person liable for-the payment mixture is included. If a chemical or of any duties on the merchandise, or any mixture containing impurities is authorized agent oh his behalf (as processed for commercial purposes, then defined in 19 CFR 1.11). (2) The consignee. those impurities are also processed for commercial purposes. (3) The importer of record. . description of a use deferaunedTcr be a" '// . significant new use is confidential treatment, apef^qn'who^. T?.;.. . intends to manufacture, imgort, or 774*1^' process that substance mayask EPA` whether his intended use of the . substance is subject to this Pah. If the . /'*' answer to the inquiry would require : . EPA to reveal otherwise confidential ' information, EPA will answer such an inquiry only if the Agency determines__ Sf - / that the person has a bona fide intent to ^ manufacture, import, or process, the substance for the use.with regard to which inquiry is made. (b) If inquiry is made concerning the particular use or uses of the substance, to establish the bona fide intent the / person must submit to EPAi^/V5r-. ' (1) A signed statement'.uiat the person * 2 intends to manufacture, import, or - process the substance for the indicated^ ' * ' . purposes. (2) A description of the research and (4) The actual owner if an actual 721.5 Persons who must report. development activities he has conducted owner's declaration and superseding (a) General. The following persons to date. . bond has been filed in accordance with must submit a notice under the (c) EPA will compare the use , . 19 CFR Part 141.20. provisions of section 5(a)(1)(B) of TSCA information submitted with information (5) The transferee, if the right to draw and of this Part: v on existing uses and will inform the ./ ' merchandise in a bonded warehouse has (1) Any person who intends to . submitter whether a notice of significant^ been transferred in accordance with manufacture in the United States for new use is required if the person intends' Subpart C of 19 CFR Part 144. For the commercial purposes any chemcial to manufacture, import, or process the ' purpose of this definition the Customs substance listed in Subpart B of this substance for that purpose. . ' .. KMX 01155 V 78978 Federal Register / VoL 45, No. 230 / Wednesday, November 26, 1980 / Proposed Rules' (d) A disclosure of the use description of a substance to a person with a bona fide intent to manufacture, import, or process a particular chemical substance for that particular use will not be considered a disclosure of confidential information. f--f> "" - -v- ' (e) EPA will provide a final response to an inquiry under these procedures - within 45 days after the Agency's receipt of a complete submission under - . ! paragraph (b) of this section. ' . -; $721.15 Exemptions and exclusions. The exemptions and exemption ^ authorities of Bee. 5(h) of TSCA apply without modification to any significant new uses defined in this Part. 1. Subpart B--New Uses For Specific Chemical Substances . 721.175 N-methanesulfonyl-p-'' ' toluenesulfonamide. EPA has determined that the ; following are "significant new uses" of the chemical substance N-" " " methanesulfonyl-p-toluenesulfdnamide: fa) Use of the substance as other than confidential qualitative use, unless the" new qualitative use is excluded under $ 721.15. . y.' v (b) Manufacture or import of an . .. amount of the substance in excess of . S 1,000 pounds per annum for use as a confidential qualitative use. . [FRDoc. ss-3ssga FUed 11-aMSs MS) - ' BnOJNG CODE 6560-31-M ....... .... . ' ............... . -. ...- ; 'll' . r,, W . . ' - f> . . f* * . " -yiy.r . -V .n* O'''*:'. - . . . .s&saC .1 . ... , ... " . - - > .WO- . . vv ... '. ;T i)C- v-V ^ i '- ' -V s&vjjpj.gy `1,4 r ,r^ ijoiY'Jii ! \.... , . '. .. f i KMX 01156 ;S " ' :^.W3.nr v . United States Environmental Protection AflWCV TS 7 99- Washington DC 20460 -V Official Business Penalty for Private Use *300 ---------_-r". . ' - : '"'Vr v Pottage and Fees Paid EPA " Permit No. G-35 - 4- * - - ' . . ' r - -if.->% ^ .. "K 'fcv5-, V v