Document ID: EPA-HQ-OPPT-2016-0675-0022
Agency: epa
Document Type: Notice
Title: Toxic Substances Control Act Reporting and Recordkeeping Requirements: Standards for Small Manufacturers and Processors; Final Determination
Posted Date: 2017-11-30T05:00Z

[Federal Register Volume 82, Number 229 (Thursday, November 30, 2017)]
[Notices]
[Pages 56824-56826]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25822]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2016-0675; FRL-9968-41]

TSCA Reporting and Recordkeeping Requirements; Standards for 
Small Manufacturers and Processors; Final Determination

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: On December 15, 2016, EPA issued a notice in the Federal 
Register requesting public comment on whether revision to the current 
size standards for small manufacturers and processors, which are used 
in connection with reporting regulations under the Toxic Substances 
Control Act (TSCA) section 8(a), is warranted. This document describes 
EPA's final determination that revision to the current size standards 
is warranted.

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
Lynne Blake-Hedges, Chemistry, Economics, and Sustainable Strategies 
Division (7406M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: (202) 564-8807; email 
address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture 
or process chemical substances or mixtures. The following list of North 
American Industrial Classification System (NAICS) codes is not intended 
to be exhaustive, but rather provides a guide to help readers determine 
whether this document applies to them. Potentially affected entities 
may include:
     Basic Chemical Manufacturers (NAICS code 3251);
     Resin, Synthetic Rubber, and Artificial Synthetic Fibers 
and Filament Manufacturers (NAICS code 3252);
     Pesticide, Fertilizer, and Other Agricultural Chemical 
Manufacturers (NAICS code 3253);
     Paint, Coating, and Adhesive Manufacturers (NAICS code 
3255);
     Other Chemical Product and Preparation Manufacturers 
(NAICS code 3259); and
     Petroleum Refineries (NAICS code 32411).

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification 
(ID) number EPA-HQ-OPPT-2016-0675, is available at http://www.regulations.gov or at the Office of Pollution Prevention and Toxics 
Docket (OPPT Docket), Environmental Protection Agency Docket Center 
(EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 
Constitution Ave. NW., Washington, DC. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280. Please review the visitor instructions and additional information 
about the docket available at http://www.epa.gov/dockets.

II. What action is the agency taking?

    On June 22, 2016, President Obama signed into law the Frank R. 
Lautenberg Chemical Safety for the 21st Century Act which amends the 
Toxic Substance Control Act (TSCA), the nation's primary chemicals 
management law. A summary of the new law is available at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/frank-r-lautenberg-chemical-safety-21st-century-act. This particular action 
involves revised TSCA section 8(a)(3)(C), which requires EPA, after 
consultation with the Administrator of the Small Business 
Administration, to review the adequacy of the standards for determining 
which manufacturers and processors qualify as small manufacturers and 
processors for purposes of TSCA sections 8(a)(1) and 8(a)(3). (Note 
that under TSCA section 3(9), manufacture includes import.) TSCA 
furthermore requires that (after consulting with the Small Business 
Administration and providing public notice and an opportunity for 
comment) EPA determine whether revision of the standards is warranted. 
For the reasons described below, EPA determines that revision of the 
standards is warranted.
    In the 1980s, EPA issued standards that are used in identifying 
which businesses qualify as small manufacturers and processors for 
purposes of the reporting and recordkeeping rules issued under TSCA 
section 8(a). Under TSCA section 8(a)(1), small manufacturers and 
processors are generally exempt from section 8(a) reporting 
requirements, except in limited cases set forth in TSCA section 
8(a)(3).
    In 1982, EPA finalized standards for determining which 
manufacturers of a reportable chemical substance qualify as small 
manufacturers for purposes of the section 8(a) Preliminary Assessment 
Information Reporting (PAIR) rules, codified in 40 CFR part 712, 
subpart B. The small manufacturer standard for PAIR rules is found at 
40 CFR 712.25(c).
    In 1988, EPA established general small manufacturer standards for 
use in other rules issued under TSCA section 8(a) (40 CFR 704.3). For 
example, these are the standards that now apply to the Chemical Data 
Reporting (CDR) rule (40 CFR part 711). The general standards are 
somewhat different from the earlier standards that are codified for use 
in the PAIR rules. The general small manufacturer standards are as 
follows:
    Small manufacturer or importer means a manufacturer or importer 
that meets either of the following standards:
    1. First standard. A manufacturer or importer of a substance is 
small if its total annual sales, when combined with those of its parent 
company (if any), are less than $40 million. However, if the annual 
production or importation volume of a particular substance at any 
individual site owned or controlled by the manufacturer or importer is 
greater than 45,400 kilograms (100,000 pounds), the manufacturer or 
importer shall not qualify as small for purposes of reporting on the 
production or importation of that substance at that site, unless the 
manufacturer or importer qualifies as small under standard (2) of this 
definition.
    2. Second standard. A manufacturer or importer of a substance is 
small if its

[[Page 56825]]

total annual sales, when combined with those of its parent company (if 
any), are less than $4 million, regardless of the quantity of 
substances produced or imported by that manufacturer or importer.
    3. Inflation index. EPA shall make use of the Producer Price Index 
for Chemicals and Allied Products, as compiled by the U.S. Bureau of 
Labor Statistics, for purposes of determining the need to adjust the 
total annual sales values and for determining new sales values when 
adjustments are made. EPA may adjust the total annual sales values 
whenever the Agency deems it necessary to do so, provided that the 
Producer Price Index for Chemicals and Allied Products has changed more 
than 20 percent since either the most recent previous change in sales 
values or the date of promulgation of this rule, whichever is later. 
EPA shall provide Federal Register notification when changing the total 
annual sales values.
    Pursuant to authority under section 8(a)(3)(B), certain section 
8(a) rules codify slight variations of the general small manufacturer 
standards at 40 CFR 704.3. (See, e.g., 40 CFR 704.45). Other rules 
issued under TSCA section 8(a) establish (for use in a particular rule) 
analogous standards for small processors (See, e.g., 40 CFR 704.33).
    As an initial step in evaluating whether a change in these current 
size standards are warranted, EPA reviewed the change in the Producer 
Price Index (PPI) for Chemicals and Allied Products between 1988 (the 
year the general size standards at 40 CFR 704.3 were last revised) and 
2015 (the most recent year of PPI data available) (Ref. 1). EPA found 
that the PPI has changed by 129 percent, far exceeding the 20 percent 
inflation index specified as a level above which EPA may adjust annual 
sales levels in the current standard if deemed necessary. This change 
to the PPI is pertinent for both the $4 million annual sales standard 
and the $40 million threshold used in the combined sales and production 
standard. Furthermore, among the more than 500 revenue-based size 
standards set by the Small Business Administration (SBA), the lowest is 
$5.5 million, and more than 75% of those standards are in excess of 
$7.5 million. Some revenue-based standards are as high as $38.5 
million. Thus, EPA's existing $4 million annual sales standard is an 
outlier at the low end of this range. Along the same lines, the sales-
only size standard EPA recently adopted for the TSCA section 8(a) 
nanoscale reporting rule is $11 million, significantly larger than $4 
million. Because of the magnitude of the increase in the PPI since the 
last revision of the size standards and because the current annual 
sales standard is comparatively low given current revenue-based size 
standards developed by SBA, EPA preliminarily determined that a 
revision to currently codified size standards is warranted.
    On December 15, 2016, EPA published its preliminary determination 
and requested public comment on the adequacy of the current standards 
and whether revision of the standards is warranted. In addition, EPA 
consulted with the SBA and received feedback on the consultation from 
SBA on April 5, 2017. SBA's consultation feedback recommended that EPA 
``apply a comprehensive approach that not only evaluates inflation but 
also examines other important factors, such as the characteristics of 
firms and industries associated with manufacturing or importation of 
chemical substances and percentage of firms impacted by the rules, to 
determine whether or not a revision to the current size standards is 
warranted.''
    EPA reopened the public comment period on May 9, 2017 to give the 
public an opportunity to review SBA's consultation feedback to inform 
their comments on EPA's preliminary determination. On May 9, 2017, 
EPA's preliminary finding and its basis remained the same as in the 
December 15, 2016 publication in the Federal Register.
    EPA's decision not to consider a more comprehensive range of 
factors as recommended in SBA's consultation feedback before taking the 
current action is appropriate because the current action is limited to 
determining whether ``revision of the standards'' is warranted or not. 
See TSCA section 8(a)(3)(C)(ii). (The set of size standards covered by 
this determination are those that EPA has issued under TSCA section 
8(a)(3)(B), pertinent to information collection under TSCA section 
8(a).) EPA found that the PPI index changed by a percentage far 
exceeding the 20 percent inflation index. EPA had previously specified 
20 percent as a level above which EPA may adjust annual sales levels in 
the current standard if deemed necessary. This change in the PPI index 
(along with the observation that the current annual sales standard is 
comparatively low given current revenue-based size standards developed 
by SBA) is a sufficient basis to determine that some revision of the 
standards is warranted, even if there are other factors that could have 
supported the same conclusion. EPA notes that the SBA's Office of 
Advocacy substantively agreed with EPA's preliminary determination 
(that a revision to the current size standards is warranted) even 
though it requested EPA to consider additional factors in reaching that 
conclusion.
    EPA received a number of comments on its preliminary determination. 
Most commenters agreed with EPA's preliminary determination that an 
update is warranted. SBA submitted comments that argued that EPA should 
have considered more than the second (i.e., the sales-only) standard 
when making a final determination, such as whether the standard is 
structured appropriately. This comment is similar to the SBA's 
recommendation in its consultation feedback that EPA evaluate a broader 
set of factors related to firm and industry characteristics and 
percentage of firms impacted by section 8 rules to determine whether or 
not a revision to the standards is necessary. However, as previously 
noted, the change in the PPI index (along with the comparative analysis 
of the current annual sales standard) is a sufficient basis to 
determine (even if other factors could have supported the same 
conclusion) that some revision of the standards for small manufacturers 
and processors is warranted, for both the sales-only and the sales plus 
production standards.
    Two commenters questioned whether a revision to the standards is 
warranted. One of these commenters argued that the standards should not 
be changed, based on the serious nature of unspecified chemicals of 
concern. The second commenter argued that a revision to the standards 
that would result in classifying more manufacturers or processors as 
small is not warranted because states need to have complete information 
about chemical use, including volume, location, and toxicity, in order 
to effectively respond to emergencies and to prioritize resources to 
address concerns among various chemicals.
    EPA does not agree that either argument justifies a determination 
that revision of the standards is not warranted. The first commenter 
did not explain how chemical risks would be exacerbated by updating the 
status quo of small manufacturer standards. With regard to the second 
comment, the outcome of the rulemaking (i.e., whether it would result 
in exempting more firms from reporting than under the current 
standards) cannot be known until the rulemaking is complete. Although 
revising the size standards for inflation could be presumed to increase 
the number of exempt firms, the second commenter did not explain how 
such increase would necessarily translate into a loss of information 
necessary for

[[Page 56826]]

states to effectively respond to emergencies and prioritize resources. 
With respect to the need of states to have complete information about 
the toxicity of particular chemical substances, EPA notes that the size 
standards at issue in this action only relate to the collection of 
information under TSCA section 8(a). The primary information collection 
under TSCA section 8(a) is the Chemical Data Reporting rule, 40 CFR 
part 711, which collects exposure-related data rather than hazard data. 
In any event, although the exemption of small businesses from reporting 
necessarily reduces the amount of chemical information EPA collects, 
Congress nonetheless decided to provide for an exemption and directed 
EPA to determine the need for revision. As explained above, EPA 
believes the currently promulgated standards are clearly outdated with 
respect to the current understanding of what qualifies a business as 
small. EPA has not yet proposed any revisions to the size standards; 
any changes would be established through future notice and comment 
rulemaking. At that time, public comments regarding the merits of any 
proposed revisions would be sought by EPA and subsequently addressed.
    Several commenters also provided their opinions on how the 
standards should be specifically revised or explained why specific 
parts of the standards ought to be maintained. For example, SBA 
commented that, when developing standards, EPA should consider a broad 
range of factors that may potentially be relevant in the context of 
TSCA reporting. These factors include barriers to entry, start-up and 
expansion costs, capital versus labor intensiveness of industries, 
average firm size (employment and revenue), growth trends, and 
technological factors. Multiple commenters agreed with SBA's 
recommendations. Additionally, one commenter argued that the combined 
sales and production standard should be revised by lowering its 
production threshold and not changing its $40 million sales threshold. 
However, the scope of this action is limited to a general determination 
as to whether some revision to the TSCA small manufacturer and 
processor standards is warranted. More particular issues (i.e., 
relating to how the standards ought to be revised) will be addressed in 
a subsequent rulemaking and are beyond the scope of this action. 
Although EPA has no obligation to respond to the suggestions for 
specific revisions submitted as comments on this action, EPA intends to 
consider these comments as it develops its rulemaking proposal. Members 
of the public who wish to maintain previously submitted comments or who 
wish to submit new comments may do so following the publication of 
EPA's proposal in the Federal Register. EPA will address such comments 
prior to finalizing any changes to the TSCA size standards.
    EPA's preliminary determination that a revision to size standards 
was warranted did not include the size standard for nanoscale materials 
found at 40 CFR 704.20. See 81 FR 90842 (determination was only with 
respect to currently codified size standards as of December 15, 2016). 
EPA promulgated the size standards at 40 CFR 704.20 on January 12, 
2017, along with the other provisions of EPA's reporting and 
recordkeeping rule for nanoscale materials. Concurrent with 
promulgating the size standards at 40 CFR 704.20, EPA indicated that it 
would consider the adequacy of the size standards at 40 CFR 704.20 in 
the course of finalizing this determination under TSCA section 
8(a)(3)(C). 82 FR 3650. At this point, EPA has not made a determination 
as to whether the size standards in the nanotechnology rule warrant 
revision. EPA will further evaluate the need for any revision as part 
of the rulemaking to revise the standards identified in this final 
determination.
    Based on EPA's preliminary determination, a review of the comments 
on the preliminary determination, and the feedback from consultation 
from SBA, EPA is now making a final determination under TSCA section 
8(a)(3)(C)(ii) that revision to the TSCA section 8(a) size standards 
for manufacturers and processors is warranted.

III. References

    The following is a listing of the documents that are specifically 
referenced in this document. The docket includes these documents and 
other information considered by EPA, including documents that are 
referenced within the documents that are included in the docket, even 
if the referenced document is not physically located in the docket. For 
assistance in locating these other documents, please consult the 
technical person listed under FOR FURTHER INFORMATION CONTACT.
    U.S. Bureau of Labor Statistics. ``Producer Price Index, Series 
WPU06, Chemicals and Allied Products, 1933-2015''. Retrieved November 
14, 2016 from http://data.bls.gov/cgi-bin/srgatet.

    Authority:  15 U.S.C. 2607(a).

    Dated: November 21, 2017.
Charlotte Bertrand,
Acting Principal Deputy Assistant Administrator, Office of Chemical 
Safety and Pollution Prevention.
[FR Doc. 2017-25822 Filed 11-29-17; 8:45 am]
 BILLING CODE 6560-50-P