[Federal Register Volume 59, Number 161 (Monday, August 22, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-20557]
[[Page Unknown]]
[Federal Register: August 22, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[OPPTS-50621; FRL-4872-1]
RIN 2070-AB27
Dipropylene glycol dimethyl ether; Proposed Significant New Use
Rule
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing a significant new use rule (SNUR) under
section 5(a)(2) of the Toxic Substances Control Act (TSCA) for the
chemical substance described as modified propylene glycol ether, which
is the subject of premanufacture notice (PMN) P-93-507. This proposal
would require certain persons who intend to manufacture, import, or
process this substance for a significant new use to notify EPA at least
90 days before commencing any manufacturing or processing activities
for a use designated by this SNUR as a significant new use. The
required notice would provide EPA with the opportunity to evaluate the
intended use and, if necessary, to prohibit or limit that activity
before it can occur.
DATES: Written comments must be received by EPA on or before September
21, 1994.
ADDRESSES: All comments must be sent in triplicate to: Environmental
Protection Agency, OPPT Document Control Officer (7407), 401 M St.,
SW., Rm. E-G99, Washington, DC 20460. Comments that are claimed as
confidential business information (CBI) must be clearly marked CBI. If
CBI is claimed, three additional copies of the comments without the CBI
must also be submitted. Nonconfidential versions of comments on this
proposed rule will be placed in the rulemaking record and will be
available for public inspection in the TSCA Nonconfidential Information
Center (NCIC) located in Rm. NE-B607. Comments should include the
docket control number. The docket control number for the chemical
substance in this SNUR is OPPTS-50621. Unit VI. of this preamble
contains additional information on submitting comments containing
information claimed as CBI.
FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director,
Environmental Assistance Division (7408), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, Rm. E-543B, 401
M St., SW., Washington, DC 20460, Telephone: (202) 554-1404, TDD: (202)
554-0551.
SUPPLEMENTARY INFORMATION: This proposed SNUR would require persons to
notify EPA at least 90 days before commencing the manufacture, import,
or processing of the substance identified as modified propylene glycol
ether for the significant new uses described herein. The required
notice would provide EPA with information with which to evaluate an
intended use and associated activities.
I. Authority
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including those listed in section 5(a)(2). Once EPA
determines that a use of a chemical substance is a significant new use,
section 5(a)(1)(B) of TSCA requires persons to submit a notice to EPA
at least 90 days before they manufacture, import, or process the
chemical substance for that use. Section 26(c) of TSCA authorizes EPA
to take action under section 5(a)(2) with respect to a category of
chemical substances. Persons subject to this SNUR would comply with the
same notice requirements and EPA regulatory procedures as submitters of
premanufacture notices under section 5(a)(1) of TSCA. In particular,
these requirements include the information submission requirements of
section 5(b) and (d)(1), the exemptions authorized by section 5(h)(1),
(h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720.
Once EPA receives a significant new use notice (SNUN), EPA may take
regulatory action under section 5(e), 5(f), 6, or 7 to control the
activities for which it has received a SNUN. If EPA does not take
action, section 5(g) of TSCA requires EPA to explain in the Federal
Register its reasons for not taking action.
Persons who intend to export a substance identified in a proposed
or final SNUR are subject to the export notification provisions of TSCA
section 12(b). The regulations that interpret section 12(b) appear at
40 CFR part 707.
II. Applicability of General Provisions
General regulatory provisions applicable to SNURs are codified at
40 CFR part 721, subpart A. Regulatory provisions covering user fees
applicable to significant new use notices are codified at 40 CFR part
700 under the authority of TSCA section 26(b). Interested persons may
refer to these sections for further information.
III. Background
EPA is proposing to establish significant new use and recordkeeping
requirements for the chemical dipropylene glycol dimethyl ether. The
proposed SNUR designates as significant new uses:
(1) Any manner or method of manufacturing, importing, or processing
associated with any use of the substance without the use of dermal
protection, including gloves, that provides an impervious barrier to
the substance.
(2) Annual manufacture and importation volume for any use greater
than 4 times the yearly volume specified in the PMN for the substance
(annual production total must include quantities manufactured for
export and for all domestic uses).
(3) Use of the substance in a consumer product.
On February 2, 1993, EPA received a PMN, designated as P-93-507,
for a modified propylene glycol ether. Based on test data on the PMN
substance, submitted with the PMN and during the review period, EPA has
concerns for the substance's potential to cause adverse systemic,
maternal, and fetal effects. The greatest potential for risk appears to
be associated with the dermal route of exposure. The extent to which
the Agency expects that adverse effects may occur relates in large part
to the isomer mix of the PMN substance, which is a combination of three
individual isomers.
If the ratio of these isomers in the PMN substance is maintained at
certain levels, the Agency considers the potential risk to workers
during manufacturing, processing, and use to be reasonable; however, if
the formulation contains a high percentage of an isomer for which the
suspected human health hazard is significant, the Agency might consider
the risk to workers to be unreasonable. Although the Agency does not
consider the higher risk formulations likely to be made, and is
reasonably confident that the isomer of greatest potential concern will
be present at low levels (<5 percent)="" in="" the="" formulation,="" the="" pmn="" submitter="" was="" not="" able="" to="" specify="" with="" certainty="" the="" percentage="" at="" which="" each="" isomer="" would="" be="" present="" in="" the="" pmn="" substance.="" consequently,="" there="" is="" potential="" for="" the="" pmn="" substance="" to="" be="" formulated="" in="" isomer="" ratios="" that="" may="" present="" an="" unreasonable="" risk="" to="" human="" health="" as="" described="" above.="" in="" deciding="" not="" to="" regulate="" the="" pmn="" submitter="" through="" an="" administrative="" consent="" order,="" the="" agency="" balanced="" the="" potential="" risks="" from="" certain="" isomer="" formulations="" with="" the="" benefits="" to="" worker="" safety="" offered="" by="" the="" pmn="" substance="" as="" a="" substitute="" for="" more="" potentially="" hazardous="" glycol="" ethers.="" another="" factor="" in="" the="" agency's="" decision="" not="" to="" regulate="" the="" pmn="" substance="" through="" an="" order="" was="" the="" product="" stewardship="" program="" that="" the="" submitter="" had="" established="" for="" the="" substance,="" which="" included="" up-front="" glove="" testing="" to="" ensure="" that="" accurate="" information="" on="" dermal="" protection="" would="" be="" communicated="" to="" workers="" exposed="" to="" the="" substance.="" the="" results="" of="" the="" glove="" testing="" indicated="" that="" permeation="" at="" rates="" that="" might="" present="" an="" unreasonable="" risk="" could="" occur="" with="" certain="" glove="" models.="" the="" agency="" considers="" it="" prudent="" and="" necessary,="" therefore,="" that="" any="" glove="" or="" dermal="" protective="" clothing="" intended="" for="" use="" in="" handling="" the="" pmn="" substance="" be="" tested,="" or="" the="" specifications="" from="" the="" manufacturer="" or="" supplier="" evaluated,="" prior="" to="" use.="" this="" testing="" or="" evaluation="" must="" ensure="" that="" the="" protective="" item="" will="" be="" impervious="" to="" the="" pmn="" substance="" for="" the="" expected="" duration="" and="" conditions="" of="" exposure,="" which="" includes="" the="" likely="" combinations="" of="" other="" chemicals="" to="" which="" the="" item="" may="" be="" exposed="" in="" the="" work="" area.="" (each="" piece="" of="" personal="" protective="" equipment="" must="" be="" selected="" and="" used="" in="" accordance="" with="" 29="" cfr="" 1910.132="" and="" 1910.133.)="" handling="" the="" pmn="" substance="" without="" the="" use="" of="" equipment="" that="" provides="" an="" impervious="" barrier="" to="" it="" would="" be="" considered="" a="" significant="" new="" use="" requiring="" agency="" notice="" and="" appropriate="" justification.="" based="" in="" part="" on="" the="" submitter's="" commitment="" to="" incorporate="" the="" results="" of="" the="" glove="" study="" in="" its="" product="" literature,="" the="" agency="" considered="" regulation="" of="" the="" submitter="" to="" require="" use="" of="" dermal="" protective="" equipment="" under="" a="" consent="" order="" unnecessary,="" especially="" in="" view="" of="" the="" substance's="" relative="" human="" health="" advantages.="" the="" balance="" in="" favor="" of="" non-regulation="" might="" shift,="" however,="" if="" aspects="" of="" the="" manufacture="" and="" use="" of="" the="" pmn="" substance="" were="" to="" change="" from="" those="" on="" which="" the="" agency's="" risk="" assessment="" was="" originally="" based.="" the="" production="" volume="" estimated="" by="" the="" submitter="" in="" its="" pmn,="" for="" example,="" is="" expected="" to="" result="" in="" relatively="" few="" workers="" being="" exposed="" to="" the="" pmn="" substance.="" if="" the="" production="" level="" were="" to="" increase="" substantially,="" however,="" the="" number="" of="" workers="" and="" the="" duration="" of="" exposure--especially="" during="" manufacture--would="" increase="" proportionately.="" as="" a="" consequence,="" epa="" would="" need="" to="" revisit="" its="" original="" risk="" assessment,="" consider="" whether="" a="" potential="" unreasonable="" risk="" might="" result="" at="" the="" higher="" production="" levels="" and="" whether="" to="" regulate="" to="" mitigate="" that="" risk.="" of="" course,="" if="" this="" increase="" in="" production="" volume="" were="" coupled="" with="" formulation="" of="" the="" pmn="" substance="" with="" a="" proportionally="" greater="" amount="" of="" the="" isomers="" of="" concern,="" the="" potential="" risk="" to="" workers="" would="" increase="" as="" well.="" the="" filing="" of="" a="" snun="" based="" on="" production="" volume="" would="" afford="" the="" agency="" an="" opportunity="" to="" evaluate="" not="" only="" the="" increased="" worker="" exposures="" and="" risks,="" but="" also="" the="" risks="" associated="" with="" a="" particular="" isomer="" formulation="" of="" the="" pmn="" substance,="" the="" knowledge="" of="" which="" would="" be="" based="" on="" actual="" production="" experience.="" for="" purposes="" of="" determining="" the="" annual="" pmn="" production="" volume="" and="" compliance="" with="" the="" volume="" limitation,="" quantities="" of="" the="" pmn="" substance="" manufactured="" for="" both="" domestic="" use="" and="" export="" should="" be="" totaled="" (i.e.="" considered="" in="" aggregate),="" even="" if="" the="" export="" volumes="" were="" formerly="" manufactured="" ``for="" export="" only.''="" once="" domestic="" manufacture="" is="" intended="" or="" commences,="" all="" volumes="" produced--both="" for="" domestic="" consumption="" and="" export--are="" subject="" to="" pmn="" reporting="" requirements="" and="" tsca="" section="" 5="" regulation.="" also,="" the="" annual="" production="" total="" should="" reflect="" manufacture="" or="" import="" volumes="" for="" any="" and="" all="" uses;="" the="" total="" should="" not="" be="" calculated="" on="" a="" per-use-basis.="" (see="" 40="" cfr="" 720.45="" and="" associated="" agency="" guidance="" documents="" and="" instructions.)="" in="" addition,="" while="" the="" potential="" risk="" to="" workers="" from="" exposure="" to="" the="" pmn="" substance="" might="" be="" considered="" reasonable,="" similar="" exposures="" and="" risks="" to="" the="" general="" population="" by="" way="" of="" consumer="" uses="" for="" the="" pmn="" substance="" might="" not.="" the="" agency="" considers="" potential="" risks="" to="" workers="" to="" be="" mitigated="" in="" part="" by="" the="" greater="" level="" of="" protective="" measures="" normally="" found="" in="" the="" workplace="" and="" the="" generally="" greater="" awareness="" among="" workers="" of="" the="" potential="" hazards="" associated="" with="" the="" substances="" they="" handle.="" consumers,="" on="" the="" other="" hand,="" usually="" are="" not="" as="" aware="" of="" potential="" hazards,="" do="" not="" have="" access="" to="" the="" same="" types="" of="" information="" and="" protections="" available="" to="" workers,="" and="" therefore="" are="" potentially="" at="" greater="" risk="" if="" exposed="" to="" a="" hazardous="" new="" substance="" in="" a="" consumer="" product.="" thus,="" in="" an="" effort="" to="" prevent="" an="" unreasonable="" risk="" to="" the="" general="" population,="" the="" pmn="" substance="" cannot="" be="" manufactured="" or="" processed="" for="" a="" consumer="" use="" until="" that="" use="" and="" the="" potential="" exposures="" and="" risks="" associated="" with="" it="" have="" been="" reviewed="" and="" evaluated="" by="" the="" agency.="" in="" summary,="" for="" the="" reasons="" described="" above,="" the="" agency="" has="" designated="" handling="" the="" pmn="" substance="" without="" adequate="" dermal="" protection,="" production="" volume="" when="" it="" reaches="" a="" substantial="" level="" per="" year,="" and="" any="" consumer="" use="" of="" the="" pmn="" substance="" as="" significant="" new="" uses.="" iv.="" applicability="" of="" snur="" to="" uses="" occurring="" before="" effective="" date="" of="" the="" final="" snur="" epa="" has="" decided="" that="" the="" intent="" of="" section="" 5(a)(1)(b)="" is="" best="" served="" by="" designating="" a="" use="" as="" a="" significant="" new="" use="" as="" of="" the="" date="" of="" proposal="" rather="" than="" as="" of="" the="" effective="" date="" of="" the="" rule.="" if="" uses="" which="" had="" commenced="" between="" that="" date="" and="" the="" effective="" date="" of="" this="" rulemaking="" were="" considered="" ongoing,="" rather="" than="" new,="" any="" person="" could="" defeat="" the="" snur="" by="" initiating="" a="" significant="" new="" use="" before="" the="" effective="" date.="" this="" would="" make="" it="" difficult="" for="" epa="" to="" establish="" snur="" notice="" requirements.="" thus,="" persons="" who="" begin="" commercial="" manufacture,="" import,="" or="" processing="" of="" the="" substance="" for="" uses="" regulated="" under="" this="" snur="" after="" the="" date="" of="" this="" proposed="" rule="" will="" have="" to="" cease="" any="" such="" activity="" before="" the="" effective="" date="" of="" the="" rule.="" to="" resume="" their="" activities,="" such="" persons="" would="" have="" to="" comply="" with="" all="" applicable="" snur="" notice="" requirements="" and="" wait="" until="" the="" notice="" review="" period,="" including="" all="" extensions,="" expires.="" epa,="" not="" wishing="" to="" unnecessarily="" disrupt="" the="" activities="" of="" persons="" who="" begin="" commercial="" manufacture,="" import,="" or="" processing="" of="" a="" significant="" new="" use="" before="" the="" effective="" date="" of="" the="" snur,="" has="" promulgated="" provisions="" to="" allow="" such="" persons="" to="" comply="" with="" this="" proposed="" snur="" before="" it="" is="" promulgated.="" if="" a="" person="" were="" to="" meet="" the="" conditions="" of="" advance="" compliance="" as="" codified="" at="" sec.="" 721.45(h),="" the="" person="" would="" be="" considered="" to="" have="" met="" the="" requirements="" of="" the="" final="" snur="" for="" those="" activities.="" if="" persons="" who="" begin="" commercial="" manufacture,="" import,="" or="" processing="" of="" the="" substance="" between="" proposal="" and="" the="" effective="" date="" of="" the="" snur="" do="" not="" meet="" the="" conditions="" of="" advance="" compliance,="" they="" must="" cease="" that="" activity="" before="" the="" effective="" date="" of="" the="" rule.="" to="" resume="" their="" activities,="" these="" persons="" would="" have="" to="" comply="" with="" all="" applicable="" snur="" notice="" requirements="" and="" wait="" until="" the="" notice="" review="" period,="" including="" all="" extensions,="" expires.="" v.="" economic="" analysis="" epa="" has="" evaluated="" the="" potential="" costs="" of="" establishing="" significant="" new="" use="" notice="" requirements="" for="" potential="" manufacturers,="" importers,="" and="" processors="" of="" the="" chemical="" substance.="" the="" agency's="" complete="" economic="" analysis="" is="" available="" in="" the="" public="" record="" for="" this="" proposed="" rule="" (oppts-50621).="" vi.="" comments="" containing="" confidential="" business="" information="" any="" person="" who="" submits="" comments="" claimed="" as="" cbi="" must="" mark="" the="" comments="" as="" ``confidential,''="" ``trade="" secret,''="" or="" other="" appropriate="" designation.="" comments="" not="" claimed="" as="" confidential="" at="" the="" time="" of="" submission="" will="" be="" placed="" in="" the="" public="" file.="" any="" comments="" marked="" as="" confidential="" will="" be="" treated="" in="" accordance="" with="" procedures="" in="" 40="" cfr="" part="" 2.="" any="" party="" submitting="" comments="" claimed="" to="" be="" confidential="" must="" prepare="" and="" submit="" a="" nonconfidential="" public="" version="" in="" triplicate="" of="" the="" comments="" that="" epa="" can="" place="" in="" the="" public="" file.="" vii.="" rulemaking="" record="" epa="" has="" established="" a="" record="" for="" this="" rulemaking="" (docket="" control="" number="" oppts-50621).="" the="" record="" includes="" basic="" information="" considered="" by="" the="" agency="" in="" developing="" this="" proposed="" rule.="" epa="" will="" supplement="" the="" record="" with="" additional="" information="" as="" it="" is="" received.="" epa="" will="" accept="" additional="" materials="" for="" inclusion="" in="" the="" record="" at="" any="" time="" between="" this="" proposal="" and="" designation="" of="" the="" complete="" record.="" epa="" will="" identify="" the="" complete="" rulemaking="" record="" by="" the="" date="" of="" promulgation.="" a="" public="" version="" of="" the="" record,="" without="" any="" cbi,="" is="" available="" in="" the="" tsca="" nonconfidential="" information="" center="" (ncic)="" from="" 12="" noon="" to="" 4="" p.m.,="" monday="" through="" friday,="" except="" legal="" holidays.="" the="" tsca="" nonconfidential="" information="" center="" is="" located="" in="" rm.="" ne-b607,="" 401="" m="" st.,="" sw.,="" washington,="" dc.="" viii.="" regulatory="" assessment="" requirements="" a.="" executive="" order="" 12866="" under="" executive="" order="" 12866="" (58="" fr="" 51735,="" october="" 4,="" 1993),="" the="" agency="" must="" determine="" whether="" the="" regulatory="" action="" is="" ``significant''="" and="" therefore="" subject="" to="" review="" by="" the="" office="" of="" management="" and="" budget="" (omb)="" and="" the="" requirements="" of="" the="" executive="" order.="" under="" section="" 3(f),="" the="" order="" defines="" a="" ``significant="" regulatory="" action''="" as="" an="" action="" that="" is="" likely="" to="" result="" in="" a="" rule:="" (1)="" having="" an="" annual="" effect="" on="" the="" economy="" of="" $100="" million="" or="" more,="" or="" adversely="" and="" materially="" affecting="" a="" sector="" of="" the="" economy,="" productivity,="" competition,="" jobs,="" the="" environment,="" public="" health="" or="" safety,="" or="" state,="" local="" or="" tribal="" governments="" or="" communities="" (also="" referred="" to="" as="" ``economically="" significant'');="" (2)="" creating="" serious="" inconsistency="" or="" otherwise="" interfering="" with="" an="" action="" taken="" or="" planned="" by="" another="" agency;="" (3)="" materially="" altering="" the="" budgetary="" impacts="" of="" entitlement,="" grants,="" user="" fees,="" or="" loan="" programs="" or="" the="" rights="" and="" obligations="" of="" recipients="" thereof;="" or="" (4)="" raising="" novel="" legal="" or="" policy="" issues="" arising="" out="" of="" legal="" mandates,="" the="" president's="" priorities,="" or="" the="" principles="" set="" forth="" in="" this="" executive="" order.="" pursuant="" to="" the="" terms="" of="" this="" executive="" order,="" epa="" has="" determined="" that="" this="" proposed="" rule="" is="" not="" ``significant''="" and="" is="" therefore="" not="" subject="" to="" omb="" review.="" b.="" regulatory="" flexibility="" act="" under="" the="" regulatory="" flexibility="" act="" (5="" u.s.c.="" 605(b)),="" epa="" has="" determined="" that="" this="" proposed="" rule="" would="" not="" have="" a="" significant="" impact="" on="" a="" substantial="" number="" of="" small="" businesses.="" epa="" has="" not="" determined="" whether="" parties="" affected="" by="" this="" proposed="" rule="" would="" likely="" be="" small="" businesses.="" however,="" epa="" expects="" to="" receive="" few="" snuns="" for="" this="" substance.="" therefore,="" epa="" believes="" that="" the="" number="" of="" small="" businesses="" affected="" by="" the="" proposed="" rule="" would="" not="" be="" substantial,="" even="" if="" all="" of="" the="" snun="" submitters="" were="" small="" firms.="" c.="" paperwork="" reduction="" act="" omb="" has="" approved="" the="" information="" collection="" requirements="" contained="" in="" this="" proposed="" rule="" under="" the="" provisions="" of="" the="" paperwork="" reduction="" act="" (44="" u.s.c.="" 3501="" et="" seq.),="" and="" has="" assigned="" omb="" control="" number="" 2070-="" 0012.="" public="" reporting="" burden="" for="" this="" collection="" of="" information="" is="" estimated="" to="" vary="" from="" 30="" to="" 170="" hours="" per="" response,="" with="" an="" average="" of="" 100="" hours="" per="" response,="" including="" time="" for="" reviewing="" instructions,="" searching="" existing="" data="" sources,="" gathering="" and="" maintaining="" the="" data="" needed,="" and="" completing="" and="" reviewing="" the="" collection="" of="" information.="" send="" comments="" regarding="" the="" burden="" estimate="" or="" any="" other="" aspect="" of="" this="" collection="" of="" information,="" including="" suggestions="" for="" reducing="" this="" burden,="" to="" chief,="" information="" policy="" branch="" (2131),="" environmental="" protection="" agency,="" 401="" m="" st.,="" sw.,="" washington,="" dc="" 20460;="" and="" to="" office="" of="" information="" and="" regulatory="" affairs,="" office="" of="" management="" and="" budget,="" washington,="" dc="" 20503,="" marked="" ``attention:="" desk="" officer="" for="" epa.''="" the="" final="" rule="" will="" respond="" to="" any="" omb="" or="" public="" comments="" on="" the="" information="" requirements="" contained="" in="" this="" proposal.="" list="" of="" subjects="" in="" 40="" cfr="" part="" 721="" environmental="" protection,="" chemicals,="" hazardous="" materials,="" reporting="" and="" recordkeeping="" requirements,="" significant="" new="" uses.="" dated:="" august="" 12,="" 1994.="" joseph="" a.="" carra,="" acting="" director,="" office="" of="" pollution="" prevention="" and="" toxics.="" therefore,="" it="" is="" proposed="" that="" 40="" cfr="" part="" 721="" be="" amended="" as="" follows:="" part="" 721--[amended]="" 1.="" the="" authority="" citation="" for="" part="" 721="" would="" continue="" to="" read="" as="" follows:="" authority:="" 15="" u.s.c.="" 2604,="" 2607,="" and="" 2625(c).="" 2.="" by="" adding="" new="" sec.="" 721.3550="" to="" subpart="" e="" to="" read="" as="" follows:="" sec.="" 721.3550="" dipropylene="" glycol="" dimethyl="" ether.="" (a)="" chemical="" substances="" and="" significant="" new="" uses="" subject="" to="" reporting.="" (1)="" the="" chemical="" substance="" identified="" as="" dipropylene="" glycol="" dimethyl="" ether="" (pmn="" p-93-507)="" is="" subject="" to="" reporting="" under="" this="" section="" for="" the="" significant="" new="" uses="" described="" in="" paragraph="" (a)(2)="" of="" this="" section.="" (2)="" the="" significant="" new="" uses="" are:="" (i)="" protection="" in="" the="" workplace.="" requirements="" as="" specified="" in="" 40="" cfr="" 721.63(a)(1),="" (a)(2)(i),="" and="" (a)(3).="" (ii)="" industrial,="" commercial,="" and="" consumer="" activities.="" requirements="" as="" specified="" in="" 40="" cfr="" 721.80(o)="" and="" annual="" manufacture="" and="" importation="" volume="" for="" any="" use="" greater="" than="" 4="" times="" the="" yearly="" volume="" specified="" in="" the="" pmn="" for="" the="" substance.="" (b)="" specific="" requirements.="" the="" provisions="" of="" subpart="" a="" of="" this="" part="" apply="" to="" this="" section="" except="" as="" modified="" by="" this="" paragraph.="" (1)="" recordkeeping="" requirements.="" recordkeeping="" requirements="" specified="" in="" sec.="" 721.125(a),="" (b),="" (c),="" and="" (i)="" are="" applicable="" to="" manufacturers,="" importers,="" and="" processors="" of="" this="" substance.="" (2)="" limitations="" or="" revocation="" of="" certain="" notification="" requirements.="" the="" provisions="" of="" sec.="" 721.185="" apply="" to="" this="" significant="" new="" use="" rule.="" [fr="" doc.="" 94-20557="" filed="" 8-19-94;="" 8:45="" am]="" billing="" code="" 6560-50-f="">