Document ID: EPA-HQ-OPPT-2014-0809-0018
Agency: epa
Document Type: Rule
Title: Partial Exemption of Certain Chemical Substances from Reporting Additional Chemical Data
Posted Date: 2016-03-29T04:00Z

[Federal Register Volume 81, Number 60 (Tuesday, March 29, 2016)]
[Rules and Regulations]
[Pages 17392-17395]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07086]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

 40 CFR Part 711

[EPA-HQ-OPPT-2014-0809; FRL-9941-19]

Partial Exemption of Certain Chemical Substances From Reporting 
Additional Chemical Data

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: EPA is amending the list of chemical substances that are 
partially exempt from reporting additional information under the 
Chemical Data Reporting (CDR) rule. EPA has determined that, based on 
the totality of information available on the chemical substances listed 
in this final rule, there is a low current interest in their CDR 
processing and use information. EPA reached this conclusion after 
considering a number of factors, including the risk of adverse human 
health or environmental effects, information needs for CDR processing 
and use information, and the availability of other sources of 
comparable processing and use information.

DATES: This final rule is effective March 29, 2016.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPPT-2014-0809, 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.

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
Christina Thompson, Chemical Control Division (7405M), Office of 
Pollution Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(202) 564-0983; email address: thompson.christina@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. Does this action apply to me?

    You may be potentially affected by this action if you manufacture 
(defined by statute at 15 U.S.C. 2602(7) to include import) the 
chemical substances contained in this rule. The North American 
Industrial Classification System (NAICS) codes provided here are not 
intended to be exhaustive, but rather provide a guide to help readers 
determine whether this document applies to them. Potentially affected 
entities may include chemical manufacturers subject to CDR reporting of 
one or more subject chemical substances (NAICS codes 325 and 324110), 
e.g., chemical manufacturing and petroleum refineries.

II. Background

A. What action is the agency taking?

    This partial exemption eliminates an existing reporting requirement 
under 40 CFR 711.6(b)(2). EPA is adding the following chemical 
substances to the list of chemical substances that are exempt from 
reporting the information described in 40 CFR 711.15(b)(4): Fatty 
acids, C14-18 and C16-18 unsaturated, methyl esters (Chemical Abstract 
Services Registry Number (CASRN) 67762-26-9); fatty acids, C16-18 and 
C-18 unsaturated, methyl esters (CASRN 67762-38-3); fatty acids, canola 
oil, methyl esters (CASRN 129828-16-6); fatty acids, corn oil, methyl 
esters (CASRN 515152-40-6); fatty acids, tallow, methyl esters (CASRN 
61788-61-2); and soybean oil, methyl esters (CASRN 67784-80-9). 
However, by existing terms at 40 CFR 711.6, this partial exemption will 
become inapplicable to a subject chemical substance in the event that 
the chemical substance later becomes the subject of a rule proposed or 
promulgated under section 4, 5(a)(2), 5(b)(4), or 6 of the Toxic 
Substances Control Act (TSCA); an enforceable consent agreement (ECA) 
developed under the procedures of 40 CFR part 790; an order issued 
under TSCA section 5(e) or 5(f); or relief that has been granted under 
a civil action under TSCA section 5 or 7.
    In the January 27, 2015 Federal Register (80 FR 4482)(FRL-9921-56), 
EPA published a direct final rule to add these six chemical substances 
to the list of chemical substances that are partially exempt from 
reporting additional information under the CDR rule. EPA received one 
adverse comment that was pertinent to all six of the chemical 
substances that were the subject of that direct final rule. In 
accordance with the procedures described in the January 27, 2015 
Federal Register document, EPA withdrew the direct final rule, and 
subsequently proposed to add the six chemical substances to the list of 
chemical substances that are partially exempt from reporting additional 
information under the CDR rule in the July 22, 2015 Federal Register 
(80 FR 43383) (FRL-9928-99). EPA received one comment on the proposed 
rule. Before taking final action, EPA considered both the comment it 
received in response to the direct final rule and the comment it 
received in response to the proposed rule. A full discussion of EPA's 
responses to these comments is included in Unit V. of this document.

[[Page 17393]]

B. What is the agency's authority for taking this action?

    This action is finalized under the authority of TSCA, 15 U.S.C. 
2600 et seq., to carry out the provisions of section 8(a), 15 U.S.C. 
2607(a). TSCA section 8(a) authorizes EPA to promulgate rules under 
which manufacturers of chemical substances and mixtures must submit 
such information as the Agency may reasonably require. The partial 
exemption list was established in 2003 (Ref. 1) and can be found in 40 
CFR 711.6.
    Consistent with section 553 of the Administrative Procedure Act 
(APA), 5 U.S.C. 553, EPA is finalizing this action based on public 
notice and opportunity to comment afforded by the July 22, 2015 
proposed rule. Under section 553(d)(1) of the APA, the Agency may make 
a rule immediately effective ``which grants or recognizes an exemption 
or relieves a restriction.'' EPA has determined that this action 
``relieves a restriction'' by creating a partial exemption from CDR 
reporting, without creating any new reporting or recordkeeping 
requirements, and that this action will be effective immediately upon 
publication in the Federal Register.

C. Why is the agency taking this action?

    This rule is in response to a petition EPA received for these 
chemical substances (Refs. 2 and 3) submitted under 40 CFR 
711.6(b)(2)(iii)(A). EPA reviewed the information put forward in the 
petition and additional information against the considerations listed 
at 40 CFR 711.6(b)(2)(ii). EPA's chemical substance-specific analysis 
is detailed in supplementary documents available in the docket under 
docket ID number EPA-HQ-OPPT-2014-0809 (Refs. 4, 5, 6, 7, 8, and 9). 
The Agency is adding these chemical substances to the partially exempt 
chemical substances list because it has concluded that, based on the 
totality of information available, the CDR processing and use 
information for these chemical substances is of low current interest.

D. What are the impacts of this action?

    There are no costs associated with this action and the benefits 
provided would be related to avoiding potential costs. This partial 
exemption eliminates an existing reporting requirement without imposing 
any new requirements. See also the discussion in Unit VI.

III. Petition Process and ``Low Current Interest'' Partial Exemption

    In 2003 (Ref. 1), EPA established a partial exemption for certain 
chemical substances for which EPA determined the processing and use 
information required in 40 CFR part 711 to be of ``low current 
interest.'' That provision establishes a particular procedure whereby 
the public may petition EPA to add or remove a chemical substance to or 
from the list of partially exempt chemical substances. In determining 
whether the partial exemption should apply to a particular chemical 
substance, EPA considers the totality of information available for the 
chemical substance in question, including but not limited to 
information associated with one or more of the considerations listed at 
40 CFR 711.6(b)(2)(ii).
    The addition of a chemical substance under this partial exemption 
will not necessarily be based on its potential risks. The addition is 
based on the Agency's current assessment of the need for collecting CDR 
processing and use information for that chemical substance, based upon 
the totality of information available during the petition review 
process. Additionally, interest in a chemical substance or a chemical 
substance's processing and use information may increase in the future, 
at which time EPA will reconsider the applicability of a partial 
exemption for a chemical substance.

IV. Rationale for These Partial Exemptions

    EPA is granting a partial exemption for: Fatty acids, C14-18 and 
C16-18 unsaturated, methyl esters (CASRN 67762-26-9); fatty acids, C16-
18 and C-18 unsaturated, methyl esters (CASRN 67762-38-3); fatty acids, 
canola oil, methyl esters (CASRN 129828-16-6); fatty acids, corn oil, 
methyl esters (CASRN 515152-40-6); fatty acids, tallow, methyl esters 
(CASRN 61788-61-2); and soybean oil, methyl esters (CASRN 67784-80-9) 
because the Agency has concluded it has low current interest in the 
processing and use information for these chemical substances. EPA made 
these determinations based on its analysis of the totality of 
information available on the six chemical substances, including 
information about the chemical substances relevant to the 
considerations defined at 40 CFR 711.6(b)(2)(ii). EPA's chemical 
substance-specific analysis is detailed in supplementary documents 
available in the docket under docket ID number EPA-HQ-OPPT-2014-0809 
(Refs. 4, 5, 6, 7, 8, and 9).

V. Response to Comment

    The Agency reviewed and considered both comments received related 
to the direct final rule and the proposed rule.
    Comment 1: The commenter states that methyl esters can degrade to 
methanol, and provides references to support this statement. The 
commenter questioned how the possible existence of methanol from methyl 
esters can be ignored as ``a hazard for human health and the 
environment.''
    EPA Response: EPA is aware that some methanol may be formed when 
methyl esters degrade. However, under both aerobic and anaerobic 
conditions, such methanol is itself rapidly degraded (Ref. 10). 
Therefore, EPA does not expect exposure to methanol from use of the six 
biofuels included in this petition for partial exemption. Note also 
that the inclusion of a chemical substance under this partial exemption 
is not a determination on the potential risks of a chemical substance. 
Rather, it is a determination that there is a low current interest in 
CDR processing and use information for that substance. Hazard alone is 
not determinative of the level of interest in such information. Other 
pertinent factors include the information needs of various parties and 
the current availability of comparable processing and use information. 
The commenter did not assert that he had a particular need for 
additional CDR information about the processing and use of these 
chemical substances. Nor did he dispute EPA's characterization of the 
currently available processing and use information. If the level of 
interest in the CDR processing and use information for any listed 
chemical substance were to change after final listing, EPA may 
reevaluate the listing decision and pursue amendment of the listing as 
appropriate.
    Comment 2: The Biobased and Renewable Advocacy Group (BRAG), the 
group that submitted the petitions to EPA for these chemical 
substances, submitted a comment on the proposed rule in support of 
adding these chemical substances to the list at 40 CFR 711.6(b)(2)(iv). 
BRAG's comment stated that these chemical substances should be treated 
similarly to the petroleum products included in 40 CFR 711.6(b)(1) due 
to the conditions of manufacture and the properties and uses of the 
substances. The commenter also notes that based on the considerations 
listed at 40 CFR 711.6(b)(2)(ii) ``a partial reporting exemption does 
not require that EPA determine that an affected substance poses neither 
hazard nor toxicity.''

[[Page 17394]]

    EPA Response: This partial exemption decision is based on the 
considerations described under 40 CFR 711.6(b)(2)(ii). EPA has made no 
determination whether any of the six chemical substances should be, as 
the commenter BRAG suggested, treated similarly to the petroleum 
products included in 40 CFR 711.6(b)(1) due to the conditions of 
manufacture and the properties and uses of the substances. This latter 
issue is moot because equivalent partial exemptions are being granted 
under 40 CFR 711.6(b)(2)(ii).
    EPA agrees that in this action it is not making a determination of 
the potential risks of the six chemical substances.

VI. Economic Impacts

    EPA has evaluated the economic consequences associated with 
amending the CDR partially exempt chemical substances list. Since this 
final rule creates a partial exemption from CDR reporting, without 
creating any new reporting or recordkeeping requirements, this action 
does not impose any new burden. Based on the currently approved 
Information Collection Request (ICR), the burden estimates for 
reporting processing and use information total 65.63 hours with an 
associated cost of $4,367 per submission. Based on 2012 CDR reporting, 
EPA estimates that 61 submissions with manufacture volumes of 25,000 
pounds or greater will be received for these chemical substances in 
2016 and subsequent reporting years.
    Eliminating the requirement to report processing and use 
information for these submissions results in a total burden savings of 
approximately 4,003 hours and $266,387 in future reporting cycles (Ref. 
11).

VII. 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.

1. EPA. TSCA Inventory Update Rule Amendments; Final Rule. Federal 
Register (68 FR 848, January 7, 2003) (FRL-6767-4).
2. Letter from Biobased and Renewable Products Advocacy Group, to 
EPA, OPPT CDR Submission Coordinator, October 21, 2014. Docket ID 
number EPA-HQ-OPPT-2014-0809, regarding request for exemption of 
biodiesel products.
3. Letter from Biobased and Renewable Products Advocacy Group, to 
EPA, OPPT CDR Submission Coordinator, November 5, 2014. Docket ID 
number EPA-HQ-OPPT-2014-0809, supplement to request for exemption of 
biodiesel products.
4. EPA, OPPT. Fatty acids, C14-18 and C16-18 unsaturated, methyl 
esters (CASRN 67762-26-9) Partial Exemption Analysis. December 2014.
5. EPA, OPPT. Fatty acids, C16-18 and C-18 unsaturated, methyl 
esters (CASRN 67762-38-3) Partial Exemption Analysis. December 2014.
6. EPA, OPPT. Fatty acids, canola oil, methyl esters (CASRN 129828-
16-6) Partial Exemption Analysis. December 2014.
7. EPA, OPPT. Fatty acids, corn oil, methyl esters (CASRN 515152-40-
6) Partial Exemption Analysis. December 2014.
8. EPA, OPPT. Fatty acids, tallow, methyl esters (CASRN 61788-61-2) 
Partial Exemption Analysis. December 2014.
9. EPA, OPPT. Soybean oil, methyl esters (CASRN 67784-80-9) Partial 
Exemption Analysis. December 2014.
10. OECD (Organization for Economic Co-operation and Development). 
2004. SIDS (Screening Information Data Set) Initial Assessment 
Report: Methanol. SIAM 19. Berlin, Germany, 18-20 October, 2004.
11. EPA, OPPT. Cost Savings Estimate of Adding Six Chemicals to the 
40 CFR 711.6(b)(2)(iv) List of Chemical Substances. December 2015.

VIII. Statutory and Executive Order Reviews

    Additional information about these statutes and Executive Orders 
can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was 
therefore not submitted to the Office of Management and Budget (OMB) 
for review under Executive Orders 12866, October 4, 1993 (58 FR 51735) 
and 13563, January 21, 2011 (76 FR 3821).

B. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection 
requirements that would require additional review or approval by OMB 
under the PRA, 44 U.S.C. 3501 et seq.
    The information collection requirements related to CDR have already 
been approved by OMB pursuant to the PRA under OMB control number 2070-
0162 (EPA ICR No. 1884.08). Since this action creates a partial 
exemption from that reporting, without creating any new reporting or 
recordkeeping requirements, this action does not impose any new burdens 
that require additional OMB approval.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic 
impact on a substantial number of small entities under the RFA, 5 
U.S.C. 601 et seq. In making this determination, the impact of concern 
is any significant adverse economic impact on small entities. An agency 
may certify that a rule will not have a significant economic impact on 
a substantial number of small entities if the rule has no net burden 
effect or otherwise has a positive economic effect on the small 
entities subject to the rule.
    As indicated previously, EPA is eliminating an existing reporting 
requirement for the chemical identified in this document. In granting a 
partial exemption from existing reporting, this final rule does not 
have a significant economic impact on any affected entities, regardless 
of their size.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or 
more as described in UMRA, 2 U.S.C. 1531-1538, and does not 
significantly or uniquely affect small governments. In granting a 
partial exemption from existing reporting, this action imposes no new 
enforceable duty on any State, local or tribal governments, or on the 
private sector. In addition, based on EPA's experience with chemical 
data reporting under TSCA, State, local, and Tribal governments are not 
engaged in the activities that would require them to report chemical 
data under 40 CFR part 711. Accordingly, this action is not subject to 
the requirements of UMRA, 2 U.S.C. 1501 et seq.

E. Executive Order 13132: Federalism

    This action does not have federalism implications as specified in 
Executive Order 13132, August 10, 1999 (64 FR 43255). It will not have 
substantial direct effects on States, on the relationship between the 
national government and the States, or on the distribution of power and 
responsibilities among the various levels of government. Thus, 
Executive Order 13132 does not apply to this action.

F. Executive Order 13175: Consultation and Coordination With Indian 
Tribal Governments

    This action does not have Tribal implications as specified in 
Executive Order 13175, November 9, 2000 (65 FR 67249). This action will 
not have any effect on Tribal governments, on the relationship between 
the Federal Government and the Indian Tribes, on the distribution of 
power and

[[Page 17395]]

responsibilities between the Federal Government and Indian Tribes. Thus 
Executive Order 13175 does not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks

    EPA interprets Executive Order 13045, April 23, 1997 (62 FR 19885) 
as applying only to those regulatory actions that concern environmental 
health or safety risks that the EPA has reason to believe may 
disproportionately affect children, per the definition of ``covered 
regulatory action'' in section 2-202 of the Executive Order. This 
action is not subject to Executive Order 13045 because it does not 
concern an environmental health risk or safety risk.

H. Executive Order 13211: Actions That Significantly Affect Energy 
Supply, Distribution, or Use

    This action is not subject to Executive Order 13211, May 22, 2001 
(66 FR 28355), because it is not a significant regulatory action under 
Executive Order 12866.

I. National Technology Transfer Advancement Act (NTTAA)

    This action does not involve any technical standards that would 
require the consideration of voluntary consensus standards pursuant to 
NTTAA section 12(d), 15 U.S.C. 272 note.

J. Executive Order 12898: Federal Actions To Address Environmental 
Justice in Minority Populations and Low-Income Populations

    This action does not involve special considerations of 
environmental justice related issues as specified in Executive Order 
12898, February 16, 1994 (59 FR 7629). This action does not address 
human health or environmental risks or otherwise have any 
disproportionate high and adverse human health or environmental effects 
on minority or low-income or indigenous populations.

IX. Congressional Review Act (CRA)

    This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA 
will submit a rule report to each House of the Congress and to the 
Comptroller General of the United States. This action is not a 
``major'' rule as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 711

    Environmental protection, Chemicals, Hazardous substances, 
Reporting and recordkeeping requirements.

    Dated: March 22, 2016.
Wendy C. Hamnett,
Director, Office of Pollution Prevention and Toxics.

    Therefore, 40 CFR chapter I is amended as follows:

PART 711--[AMENDED]

0
1. The authority citation for part 711 continues to read as follows:

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

0
2. In Sec.  711.6, add in numerical order by CASRN number the following 
entries to Table 2 in paragraph (b)(2)(iv).

Sec.  711.6  Chemical substances for which information is not required.

* * * * *
    (b) * * *
    (2) * * *
    (iv) * * *

         Table 2--CASRN of Partially Exempt Chemical Substances
------------------------------------------------------------------------
               CASRN                              Chemical
------------------------------------------------------------------------
 
                              * * * * * * *
61788-61-2........................  Fatty acids, tallow, methyl esters.
 
                              * * * * * * *
67762-26-9........................  Fatty acids, C14-18 and C16-18
                                     unsaturated, methyl esters.
67762-38-3........................  Fatty acids, C16-18 and C-18
                                     unsaturated, methyl esters.
67784-80-9........................  Soybean oil, methyl esters.
 
                              * * * * * * *
129828-16-6.......................  Fatty acids, canola oil, methyl
                                     esters.
515152-40-6.......................  Fatty acids, corn oil, methyl
                                     esters.
------------------------------------------------------------------------

[FR Doc. 2016-07086 Filed 3-28-16; 8:45 am]
BILLING CODE 6560-50-P