ARTICLE
Mar 11, 2011

The Constantly Pending PMN: Low Volume Exemption Applications Are Living Documents
When available, a Low Volume Exemption ("LVE") is an attractive and quicker path to commercial marketing than
filing a full premanufacture notification ("PMN") pursuant to the Toxic Substances Control Act ("TSCA").
Specifically, because LVE substances are never listed on the TSCA Chemical Substances Inventory ("Inventory"),
having an LVE is akin to operating under a constantly pending PMN, obligating an LVE holder to submit to the
United States Environmental Protection Agency ("EPA") information on changes to the process of manufacturing the
LVE substance and on significant new information about the substance for the life of the exemption. As described
below, the on-going notice requirement is a point worth noting when considering the advantages and
disadvantages of filing an application for an LVE.
Premanufacture Notices
Pursuant to TSCA section 5, anyone who plans to manufacture or import a new chemical substance for a
non-exempt commercial purpose is required to provide EPA with notice before initiating the activity.[1] This
notice, the PMN, must be submitted at least 90 days prior to the manufacture or import of the chemical.[2] An
obligation exists for the submitter during review of the PMN to provide relevant new information on the PMN
substance to EPA. As such, while approval of a PMN is pending, the submitter is obligated to provide additional
information to EPA if the information "materially adds to, changes, or otherwise makes significantly more
complete" the information included in the PMN notice.[3] Time constraints exist on submission of new information
to EPA during the PMN review as follows: the submitter must provide information to EPA within ten days of
receiving the new information, but no later than five days before the end of the notice review period (save where
new information becomes available during the last five days of the notice review period, in which case the
submitter must immediately inform EPA of the information by telephone).[4]
Once the PMN review period has ended, its content is largely irrelevant, barring the need to correct the chemical
identity or as potential evidence that the notice was not submitted in good faith. Process conditions, anticipated
end uses and markets may all change without any need to alert EPA as long as the PMN substance (or any not
otherwise regulated Inventory-listed substance) is produced. The submitter must provide notice to EPA within 30
calendar days of the date the substance is first manufactured or imported for nonexempt commercial purposes and
comply with on-going obligations to report substantial risk information under section 8(e) and other reporting and
data requirements that arise.[5] Notice takes the form of a Notice of Commencement (NOC) of Manufacture or
Import. The chemical substance is considered to be on the TSCA Inventory as soon as a complete NOC is received
by EPA. Actual EPA processing of the NOC to complete the transaction takes about four weeks.
Low Volume Exemption Applications
Not every substance requires the filing of a full PMN. Specifically, certain categories of new chemical substances
are exempted from full PMN review pursuant to regulations under TSCA section 5(h)(4), viz., chemicals
manufactured at 10,000 kg/year or less.[6] The advantage of filing an LVE application is that it undergoes only a
30-day review and is not subject to user fees. It is an attractive option for high-toxicity substances since risks are

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 mitigated by the limitations on exposure. If submitted as a PMN, the same substance might well wind up being
regulated under section 5(e).
Reliance on an LVE can be problematic from a customer assurance standpoint because the substance never
becomes an "existing" chemical substance listed on the TSCA Inventory.[7] Moreover, the right to manufacture is
limited to the LVE holder, although EPA can approve more than one LVE per chemical substance.[8] Furthermore,
the conditions of approval must be followed. At times this may require manufacturers to notify processors and
industrial users of the LVE substance that the substance can only be used for specific purposes and with specific
controls.[9]
PMN-like data obligations also continue to apply to the manufacturer of an LVE substance even after approval of
the LVE. Specifically, LVE regulations state: "[i]f the manufacturer of a new chemical substance under the terms of
this exemption obtains test data or other information indicating that the new chemical substance may not qualify
under terms of this section, the manufacturer must submit these data or information to EPA within 15 working
days of receipt of the information."[10] Further, similar to PMN requirements, the LVE submitter is obligated to
provide additional information to EPA during the LVE review period if the information "materially adds to, changes,
or otherwise makes significantly more complete" the information included in the LVE application.[11]
The conditions of an LVE can be materially changed by more than just new health and safety information. Namely,
a holder of an LVE is bound to the conditions described in the LVE application, including:
   ▪ Use;
   ▪ Site of manufacture;
   ▪ Exposure and release controls;
   ▪ Physical form, such that the manufacturer must continue manufacturing, processing, and/or using the new
chemical substance in either the same physical form described in the LVE application or in a physical form which
will not increase the human exposure to or environmental release of the chemical substance over those exposures
or releases resulting from physical form specified in the LVE application;
   ▪ Importation only, if so specified; and
   ▪ Production volume of less than 10,000 kg per year, if the submitter agrees to be bound to that volume.[12]
As such, material changes to conditions listed above may need to be submitted to EPA in the form of a new LVE
submission, save under limited circumstances pursuant to 40 C.F.R. § 723.50(j)(6).[13]
The (j)(6) provision carves out an exception to the requirement that changes in the manufacturing site necessitate
the filing of a new submission, provided there is no greater exposure of individual workers to the LVE substance
and releases to water are negligible or zero.[14] In that case, the manufacturer need only notify EPA of the new
manufacturing site no later than 30 days after the commencement of manufacture of the new chemical substance
at the new manufacturing site.[15]

 Failure to comply with any provision discussed above is deemed a violation of TSCA and could subject the violator
to a maximum penalty of up to $37,500 per violation.[16] Moreover, EPA may seek to enjoin the manufacture or
processing of a chemical substance in violation of LVE requirements, or EPA may act to seize any chemical
substance manufactured or processed in violation of LVE requirements.
Manufacturers that rely upon LVE's should take care to implement tracking systems and standard operating
procedures that take into account that the termination of the notice period for an LVE application is only the end
of the beginning of the life of the LVE.
[1] 15 U.S.C. § 2604.
[2] PMN regulations appear at 40 C.F.R. Part 720.
[3] 40 C.F.R. §720.40(f).
[4] Id.
[5] 40 C.F.R. § 720.102(b).
[6] PMN exemption regulations appear at 40 C.F.R. Part 723.
[7] EPA, "Low Volume Exemptions," available at http://www.epa.gov/oppt/newchems/pubs/backlvem.htm (last
accessed March 9, 2011).
[8] 40 C.F.R. § 723.50(f).
[9] 40 C.F.R. § 723.50(k).
[10] 40 C.F.R. § 723.50(i) (emphasis added).
[11] Id.
[12] 40 C.F.R. § 723.50(j).
[13] 40 C.F.R. § 723.50(e) (emphasis added).
[14] 40 C.F.R. §§ 723.50(j)(6)(i)(A) and (B)
[15] 40 C.F.R. § 723.50(j)(6)(ii). The notification must contain the EPA-designated exemption number to which the
notification applies, manufacturer identity, the street address of the new manufacturing site, the date on which
manufacture commenced at the new site, the name and telephone number of a technical contact at the new site,
any claim of confidentiality, a statement that the notification is an amendment to the original exemption
application, and an original signature of an authorized official of the manufacturer.

 [16] 40 C.F.R. § 723.50(o).