National Emission Standards for Hazardous Air Pollutants:

 Site Remediation

 (40 CFR 63 subpart GGGGG)

Response to Public Comments on Proposed Amendments

U.S. Environmental Protection Agency

Office of Air Quality and Standards

Sector Policies and Programs Division

Research Triangle Park, NC 27711

September 29, 2006

TABLE OF CONTENTS

1.0  INTRODUCTION	1-1

2.0  RESPONSE TO COMMENTS ON PROPOSED AMENDMENTS	2-1

	2.1  Rule Applicability	2-1

		2.1.1  Rule Definitions	2-1

		2.1.2  Major Source Applicability Determination	2-2

		2.1.3  Applicability Determination for Remediation Sites at Oil and

		          Natural Gas Facilities Subject to Clean Air Act Section
112(n)(4) 	2-2

		2.1.4  Annual 1 Mg Site Remediation Applicability Exemption	2-3

	2.2  Short-Term Site Remediation Exemption (30-day)	2-5

	2.3   Air Emission Control Requirements	 2-9

		2.3.1  Point of Determination of Remediation Material VOHAP
Concentration	2-9

		2.3.2  Requirements for Remediation Material Management Units	2-10

		2.4.3  Requirements for Equipment Leaks	2-10

		2.3.4  Requirements for Process Vents	2-11

	2.4  Compliance Requirements	2-11

		2.4.1  Requirements for Remediation Material Sent Offsite	2-11

		2.4.2  Startup, Shutdown, and Malfunction Plan (SSMP) Requirements
2-11

	2.5  Other Comments	2-12

		2.5.1  Including Methyl Ethyl Ketone as a HAP in Subpart GGGGG Table 1
2-12

		2.5.2  Rule Editorial Corrections 	2-12

1.0 INTRODUCTION

	 Site remediation typically consists of clean-up activities to remove
pollutants from soils, sediments, and groundwater.   SEQ CHAPTER \h \r 1
The U.S. Environmental Protection Agency (EPA) promulgated National
Emission Standards for Hazardous Air Pollutants (NESHAP) to control
organic hazardous air pollutant (HAP) emissions from site remediation
activities under 40 CFR 63 subpart GGGGG (68 FR 58172, October 8, 2003).
 On May 1, 2006, EPA proposed amendments to the rule (71 FR 25531).  A
60-day period was provided to accept public comments on the proposed
amendments to subpart GGGGG.  The EPA received comments from a  SEQ
CHAPTER \h \r 1  total of 12 commenters regarding the proposed
amendments.

	 Table 1 lists the names of the commenters, their affiliations, and the
comment docket number for each set of the comment received regarding the
proposed amendments.  Copies of each of the comments submitted to EPA
are available in the public docket for the rulemaking (Docket ID No.
EPA-HQ-OAR-2002-0021) either electronically through   HYPERLINK
"http://www.regulations.gov"  www.regulations.gov  or in hard copy at
the EPA Air & Radiation Docket Office in Washington DC (EPA/DC, EPA
West, Room B102, 1301 Constitution Ave., NW, Washington, DC).    SEQ
CHAPTER \h \r 1 The following section presents responses to the
substantive public comments on proposed amendments by topic
category.Table 1.  Public Commenters on Rule Proposal (71 FR 25531)

Public Docket

EPA-HQ-OAR-2002-0021

Docket Entry No.	Commenter Name, Affiliation, Address, and Date

0035	Jason E. Farmer

Project Manager

Earth Tech

(no address provided)

May 10, 2006

0036	Unidentified commenter

0037	Mike Waller

Environmental Engineer

Ashworth Leininger Group

199 East Thousand Oaks Blvd.

Thousands Oaks, CA 91360

June 28, 2006

0038	Rich Raiders

Environmental and Sustainable Development Department

Arkema, Inc.

900 First Avenue

King of Prussia, PA 19406

June 28, 2006

0039	Matthew Todd

Regulatory Analyst

American Petroleum Institute

1220 L Street NW

Washington, DC 20005-4070

June 30, 2006

0040	W. H. Lane

(no address provided)

June 30, 2006

0041	Leslie Sur Ritts

Counsel to NRDA/CAP

National Environmental Development Association’s Clean Air Project
(NEDA/CAP)

555 13th Street NW

Washington, DC 20004

June 30, 2006

0042	David O. Plunkett

Technical Specialist

Operations Regulatory Management

The Dow Chemical Company

2301 N. Brazosport Blvd., Bldg. B-101

Freeport, TX 77541

June 30, 2006

0043	Leslie A. Hulse

Assistant General Counsel

American Chemistry Council

1300 Wilson Blvd.

Arlington, VA 22209

June 30, 2006

0044	Mary Crocket

Deputy Director

Alaska Oil and Gas Association

121 W. Fireweed Lane, Suite 207

Anchorage, AK 99503-2035

June 30, 2006

0045	Janet Bounds

Senior Environmental Scientist

Union Oil Company of California

P.O. Box 196247

Anchorage, AK 99519-6247

June 30, 2006

0046	Frederick G. Fedri

Corporate HES Air Quality Specialist

Occidental Chemical Corporation

5505 LBJ Freeway, Suite 2200

P.O. Box 809050

Dallas, TX 75380-9050

June 30, 2006

0047	Kerry Kelly

Director, Federal Public Affairs

WM Waste Management, Inc

701 Pennsylvania Ave., NW, Suite 590

Washington, DC 20004

July 25, 2006

2.0 RESPONSE TO COMMENTS ON PROPOSED AMENDMENTS

2.1  Rule Applicability

2.1.1  Rule Definitions

	Comment:  Several commenters (0039, 0044) stated that the subpart GGGGG
definition of “site remediation” is not clear whether emergency
responses to spills and the contemporaneous mitigation activities to
inhibit environmental impact of spills are “site remediations" and,
consequently, subject to requirements under the rule.  The commenters
stated that including activities such as the containment, recovery and
disposition of free product and initial efforts to remove soil to stop
further migration of the pollutant need to be conducted expediently as
"site remediations" will put severe disincentives on sources trying to
actively respond to emergency situations in a timely manner.  It is
infeasible for emergency response activities to incorporate all of the
control measures required by the rule, since such response activities
are usually characterized by rapid deployment of equipment and
personnel, and use of equipment to store recovered product that may not
be amenable to vapor containment.  One of the commenters (0039) stated
that emergency response and contemporaneous spill clean-up activities
that are conducted under a federal regulatory regime (such as OPA
removal action or other similar authorities) or equivalent state
authority are not site remediations.  Another commenter (0044)
recommended modifying the definition of “site remediation” to
exclude source control, contaminant, product recovery, or other
activities performed during emergency spill responses.  The term
“emergency spill response” could be defined as any activity that
occurs as a result of material or product release prior to assessing a
site for the extent of contamination in preparation for a site
remediation.

	Response:  Comment does not pertain to the amendments proposed for
subpart GGGGG.

	Comment:  One commenter (0041) stated that the subpart GGGGG definition
of a “remediation material” it is not clear whether waste material
generated from the cleanup of process leaks in contained areas such as
buildings or containment dikes is included under this definition.  The
commenter stated that manufacturing operations often experience small
drips and leaks of material such as fuel oil or process liquids from
pumps and connectors.  Many of these leaks occur in areas that are
contained, such as inside a building or within a concrete containment
dike, and therefore do not present any risk of contaminating
environmental media.  Equipment operators or maintenance staff generally
clean up these leaks immediately upon occurrence or soon after as part
of their normal daily manufacturing and maintenance activities.  In many
cases, cleanup of these small spills is often necessary in order to
repair the leaking equipment.  The commenter requested that materials
generated from such cleanup activities should be exempt from the rule as
“waste or residue generated by routine equipment maintenance
activities.”  The reasons presented by the commenter for the exemption
are: 1) the administrative burden of having to track and quantify
numerous small, process-related cleanups outweighs the very small
potential reduction in HAP emissions that might arise from including
these materials in the rule’s definition of “remediation
materials”; 2) application of the rule to these materials is not
consistent with EPA’s intent for the rule to address emissions from
remediation of contaminated media and also from remediation of materials
that pose a reasonable potential threat to contaminating environmental
media; and 3) it is not practical to assume these activities could be
addressed by the 30-day exemption.  The commenter recommended that the
definition of “remedial materials” be modified to clarify that the
definition does not include wastes generated by cleanup of small,
process-related leaks and spills from process equipment or manufacturing
operations.

	Response:  Comment does not pertain to the amendments proposed for
subpart GGGGG.

2.1.2	Major Source Applicability Determination

	Comment:  One commenter (0039) requested clarification on determination
of major source applicability for subpart GGGGG at a facility where the
contaminated area and remediation activities are owned and operated by a
third party other than the facility owner or operator.  The commenter
asked if the third party calculates HAP emissions for its operations
separate from the facility’s HAP emissions.  The commenter referenced
a letter submitted to EPA on June 14, 2004 requesting clarification on
this issue.

	Response:  Comment does not pertain to the amendments proposed for
subpart GGGGG.  Requests for a determination of the applicability of
subpart GGGGG to site-specific situations should be submitted to the
appropriate EPA or State authority.

	Comment:  One commenter (0044) stated that an areas source that becomes
a HAP major source due to site remediation activity should only be
subject to subpart GGGGG and not subject to any other MACT standard.
The commenter stated that completion of the remediation within the
3-year compliance period allowed for existing sources could return the
facility’s HAP emission levels below the major source threshold
levels.

	Response:  Comment does not pertain to the amendments proposed for
subpart GGGGG.

2.1.3	Applicability Determination for Remediation Sites at Oil and
Natural Gas	 	 		Facilities Subject to Clean Air Act Section 112(n)(4)

		Comment:  Several commenters (0038, 0039, 0042, 0043, 0044, 0045)
supported the proposed amendment to subpart GGGGG that would limit
emission aggregation for the major source determination at “production
field facilities” only to “glycol dehydration units”, “storage
vessels with flash emission potential”, as defined in 40 CFR 63
subpart HH and site remediation activities.  To provide clarity on this
provision, one of the commenters (0044) requested that EPA amend 40 CFR
63 subpart HH to add site remediation emissions to the other listed
categories of emissions listed in §63.761.

	Response:  In the existing Oil and Natural Gas Production NESHAP (40
CFR 63 subpart HH), we comply with the statutory directives under Clean
Air Act (CAA) section 112(n)(4) by limiting the emission points that are
aggregated for the major source status determination of a production
field facility to only the glycol dehydration units and storage vessels
with flash emission potential, as defined in the rule (see 40 CFR
63.761).  Consistent with our approach used for subpart HH, the final
amendments to subpart GGGGG specify that for a major source status
determination of a production field facility only the HAP emissions from
the glycol dehydration units and storage vessels with the potential for
flash emissions, as defined in subpart HH, are to be aggregated with the
HAP emissions from the site remediation activities at the facility.
However, for the purpose of determining the applicability of the
existing subpart HH to a production field facility, the sources to be
aggregated for the major source status determination are still only the
glycol dehydration units and storage vessels with flash emission
potential.  The final amendments to subpart GGGGG do not change the
emission points used for a major source status determination under
subpart HH.  Therefore, subpart HH should not be amended to add site
remediation emissions to the other emission points already listed in
§63.761.

	Comment:  Several commenters (0039, 0044, 0045) stated that to meet the
statutory directives under CAA section 112(n)(4) a similar applicability
determination provision proposed for facilities subject to the Oil and
Natural Gas Production NESHAP should be provided for facilities subject
to the Natural Gas Transmission and Storage Facilities NESHAP.
Consistent with the major source definition in this rule, emission
aggregation for major source status determination used to determine
applicability of natural gas transmission and storage facilities to
subpart GGGGG should be limited to pipeline compressor and pump
stations.

	Response:  We agree that to meet the statutory directives in CAA
section 112(n)(4) a similar applicability provision should be provided
in subpart GGGGG for natural gas transmission and storage facilities
consistent with the major source definition in the Natural Gas
Transmission and Storage Facilities NESHAP (40 CFR 63 subpart HHH).
Therefore, the final amendments to subpart GGGGG specify that for
natural gas transmission and storage facilities, HAP emissions are to be
aggregated for a major source status determination according to the
definition of major source as defined in subpart HHH (see 40 CFR
63.1271).

	Comment:  One commenter (0045) stated that the same applicability
exemption provided for production field facilities should be provided
for oil and gas exploration activities to be consistent with statutory
directives under CAA section 112(n)(4).

	Response:  Subpart GGGGG is not applicable to oil exploration
activities.  The rule applies only to those site remediations   SEQ
CHAPTER \h \r 1 co-located at a facility with one or more other
stationary sources that emit HAP and meet an affected source definition
specified for a source category that is regulated by another subpart in
40 CFR part 63.  There is no separate NESHAP in 40 CFR part 63 for oil
exploration activities.  Consequently, there is no need for the addition
of special language to subpart GGGGG for oil exploration activities
related to the directives of CAA section 112(n)(4).

2.1.4   Annual 1 Mg Site Remediation Applicability Exemption

	Comment:  Several commenters (0035, 0039, 0040, 0041) requested
clarification whether remediation materials from site remediations at a
facility specifically exempted under other provisions of subpart GGGGG
are counted towards the annual 1 megagram (Mg) exemption provided under
§63.7881(c).  Exempted site remediation activities cited by the
commenters include remediation research and development facilities,
equipment operated less than 300 hours per year, short duration site
remediations completed within 30 days, remediation material with less
than 500 ppmw VOHAP concentrations, remediation activities controlled to
comply with other subparts in 40 CFR parts 61 or 63, RCRA regulations,
or CERCLA regulations.  One commenter (0040) requested EPA confirm that
a facility may designate up to 1 Mg/yr of organic HAP content exempt
from the standards under subpart GGGGG, even though other site
remediations activities that are either controlled by the rule or
qualify for other exemptions result in the facility wide total organic
HAP content greater than 1 Mg/yr.  One of the commenters (0039)
requested that a descriptive phrase such as "subject to control under
this subpart" be included in the exemption and suggested specific rule
language.

	Response:  The annual 1 Mg exemption provided in §63.7881(c) is an
applicability exemption that exempts the site remediation activities
conducted at a facility from all of  SEQ CHAPTER \h \r 1  the
requirements of subpart GGGGG (except for certain recordkeeping
requirements).  The exemption may be used at a facility if the total
quantity of the HAP that is contained in the remediation material
excavated, extracted, pumped, or otherwise removed during all of the
site remediations conducted at the facility is less than 1 Mg annually.

 	The exemptions in §63.7881(b) exempt site remediations from being
subject to subpart GGGGG that are subject to certain other EPA or State
regulatory programs or are conducted at certain types of sites.
Remediation activities meeting the exemption criteria under
§63.7881(b)(2) and (3) are not counted towards the 1 Mg exemption
total.  The remaining paragraphs under 63.7881(b) pertain to overall
facility classification so the 1 Mg issue is not relevant.  It is not
appropriate to exclude any other remediation material that is exempted
under Subpart GGGGG from the 1 Mg determination because those exemptions
(e.g., 500 parts per million by weight (ppmw) VOHAP exemption, equipment
operating less than 300 hours annually) do not exempt site remediations
from being subject to subpart GGGGG, but rather exempt a site
remediation activity from being designated as an affected source under
the rule, or exempt an affected source from having to implement the
rule’s applicable air emission control requirements.

	The final amendments clarify the subpart GGGGG language with respect to
how the annual 1 Mg exemption is to be applied to a facility that meets
the applicability conditions in §63.7881(a).  (If a facility does not
meet the applicability conditions in §63.7881(a), it is not subject to
subpart GGGGG regardless of any site remediation activity that is
conducted at the facility.) The final amendments language for the
exemption does not change how the 1 Mg limit is applied nor change the
documentation requirements for the exemption, but adds clarifying
language stating that the 1 Mg limit applies on a facility-wide, annual
basis and that there is no restriction to the number of site
remediations that can be conducted under the exemption.

		Comment:  Several commenters (0039, 0041) requested that the proposed
rule language be modified to clarify that a site remediation is exempt
from the requirements of subpart GGGGG if the total HAP remediated
during the calendar year prior to the date of the remediation activity
is less than 1 Mg/yr.  The commenters state that this approach will
avoid retroactive application of the rule requirements, and will provide
a definite basis for determining applicability of the exemption.
Because the total quantity of the HAP that is contained in the
remediation material from the exempted site remediations is determined
on a cumulative basis for the calendar year, site remediation activities
performed under 1 Mg threshold early in a calendar year would be subject
to control under subpart GGGGG should the 1 Mg threshold limit be
exceeded later in the year.  Remediation activities which have been
completed should not be subject to enforcement of the subpart GGGGG
requirements retroactively (e.g., investigation of earlier handling of
remediated material sent offsite for treatment before the 1 Mg limit was
exceeded).  This assurance is needed so that future remediation activity
can take place in a timely manner, not just to meet a calendar year
threshold.  Accordingly, the commenters recommended that EPA should
clarify in the final amendments that site remediations at the facility
become subject to the subpart GGGGG requirements after the 1 Mg limit is
exceeded for the calendar year.

	Response:  The annual 1 Mg exemption is intended to be used at those
facilities for which the owners or operators know that for all of the
on-going site remediations being conducted, or for a planned site
remediation to be conducted at a given facility, the total quantity of
the organic HAP that is contained in the remediation material excavated,
extracted, pumped, or otherwise removed during all of the site
remediations conducted at the facility will remain below 1 Mg on an
annual basis.  The exemption is available to those owners and operators
of facilities where a site remediation does not qualify for one of the
applicability exemptions provided in §63.7881(b), but the potential for
total organic HAP emissions from the site remediation activities is low.
 The annual 1 Mg exemption is not intended to be used to delay
application of organic air emission controls to the site remediation
activities at a facility until the day when the total quantity of the
HAP in the remediation material removed from site remediation reaches a
1 Mg threshold limit.  An owner or operator should not rely on using
the annual 1 Mg exemption for complying with subpart GGGGG if there is
uncertainty about the total organic HAP content in the remediation
material to be removed during the site remediation conducted at the
facility or whether additional site remediations to clean up organic
contaminated media will need to be performed at the facility during the
year.

 	To clarify our intended application of the annual 1 Mg exemption, the
regulatory language for the final amendments was revised to use the term
“annual” in place of the term “calendar year” that was used for
the proposed regulatory language.

	Comment:  Several commenters (0038, 0042, 0043) stated that a facility
owner or operator wanting to use the annual 1 Mg exemption may be
required to amend its Title V operating permit to include the
recordkeeping requirements for the exemption into their permits to
comply with the provision.  This would be an unnecessary burden on both
the facility owner and the permit reviewing regulatory authority.  The
commenters requested that §63.7881(c) be modified so that a facility
does not have to resubmit or amend its Title V operating permit if the
only provisions of subpart GGGGG applicable to the facility is the
recordkeeping requirement in §63.7881(c).  To the extent necessary, a
similar amendment should be made in Table 3 to subpart GGGGG.  The
commenters noted that EPA addressed a similar Title V issue in
§63.7936(c) of the rule where it determined that an off-site
treatment/disposal facility accepting remediation material from a
remediation subject to subpart GGGGG does not, by itself, require the
facility to obtain a Title V permit.

	Response:    SEQ CHAPTER \h \r 1 The inclusion of the recordkeeping
requirement associated with the annual 1 Mg exemption is not intended
to trigger a Title V permit revision for the owner or operator of a
facility that qualifies for the exemption.  To address this situation,
we have added to the final amendments an explicit provision stating that
a Title V permit does not have to be reopened or revised solely to
include the recordkeeping requirement required for the annual 1 Mg
exemption.  However, the recordkeeping requirement must be included in
the facility’s Title V permit the next time the permit is renewed,
reopened, or revised for another reason.

2.2  Short-Term Site Remediation Exemption (30-day)

	Comment:  Several commenters (0038, 0039, 0041, 0042, 0043, 0046)
requested that EPA reconsider requiring all off-site processing and
treatment activities be completed within the 30-day period specified in
the short-term site remediation exemption as proposed under
§63.7884(b)(l).  In general, the commenters requested that a site
remediation qualifies for the exemption provided all of the remedial
material is shipped to an appropriate treatment or disposal facility
within the 30-day period.  Arguments presented by the commenters to
support their position include:  1) generators transferring the
remediation material offsite do not have control over the
treatment/disposal schedule of the receiving treatment, storage, and
disposal facility (TSDF); 2) requiring the offsite transfer, treatment
and disposal to be completed in 30 days significantly limits the number
of cleanups able to use this exemption and will be a strong disincentive
for facilities to voluntarily initiate cleanups, 3) generators may be
forced to pay a “very high premium” to the TSDF operator in order
for the remedial material to be treated within the 30-day period; and 4)
the completion of treatment activities at off-site processing and
treatment facilities are appropriately addressed in §63.7936 of the
rule and by other regulations, such as Off-Site Waste and Recovery
Operations (OSWRO) NESHAP (40 CFR 63 subpart DD) and other federal,
State and local regulations controlling volatile organic compounds
(VOC).

	One commenter (0038) stated that facilities should be able to certify
compliance with subpart GGGGG if all waste materials from a short-term
remediation activity arrive at the final disposal facility in enough
time for a typical TSDF to process the materials.  The commenter
recommended that EPA modify the proposed language to allow facilities to
use the short-term exemption if all remediation site activities are
completed within 30 days of the start of the remediation, including
completion of appropriate waste manifest documents or nonhazardous waste
shipping documentation.  The ultimate disposal activities should be
completed as soon as practicable under RCRA regulations.  The commenter
stated that the proposed amendment conflicts with established RCRA
disposal requirements and this violates the RCRA-Clean Air Act
harmonization provision under CAA Section 112(n)(7).  Two other
commenters (0042, 0043) requested that the final rule be amended to
indicate the generator of a remediation material has met their
obligation to qualify for the exemption if the material has been shipped
offsite to a TSDF within the 30 day period.  Completion of the shipment
documents (e.g., manifest) transferring the remediation material to a
TSDF by, or on, day 30 should indicate that the person undertaking the
short-term remediation has complied with the 30-day period requirements.

	One commenter (0041) requested that rather than make the facility owner
responsible for the actions of the off-site disposal facility, EPA
should finalize a rule that provides that if remediation material
transferred to an off-site facility is not treated or disposed of within
the 30-day period, the owner of the off-site facility must manage the
waste in accordance with the rule following the end of the 30-day
period.  This would provide the off-site facility an incentive to
minimize emissions by completing quickly those activities within its
control while also avoiding making the original facility owner
responsible for the inactions of an unrelated entity.  In addition, this
approach would provide a clearly defined date that owners could plan
around.  Finally, this approach would pose little or no risk of
significant HAP emissions because the small amounts of remediation
materials generated by most short-term remediations are usually
transported in enclosed containers such as drums meeting U.S. Department
of Transportation (DOT) requirements.

	Response:  The 30-day site remediation exemption provided under
§63.7884 (b) is not a general applicability exemption that exempts the
site remediation from being subject to subpart GGGGG.  Rather, under
this exemption, site remediations at a facility with affected sources
subject to regulation under subpart GGGGG that can be completed within
30-days are exempted from having to meet the air emission control
requirements specified in the rule.  Subpart GGGGG is amended to clarify
the rule language with respect to our intent for application of the
30-day site remediation exemption, including those situations when the
remediation material is transferred off-site.  The final amendment
language explicitly defines the beginning and end of the 30-day period
for the purpose of qualifying for the exemption.

	 The first day of the exemption period is defined as the day on which
the facility owner or operator initiates any action that removes,
destroys, degrades, transforms, immobilizes, or otherwise manages the
remediation materials.  Certain activities that are performed to prepare
for the actual cleanup of the contaminated media are not counted as part
of the 30-day period, provided that these activities are completed
before the actual site cleanup begins:  characterizing the type and
extent of the contamination by collecting and analyzing samples;
obtaining permits from Federal, State, or local authorities to conduct
the site remediation; scheduling workers and necessary equipment; and
arranging for contractor or third party assistance in performing the
site remediation.

	The last day of the exemption period is defined as the day on which all
of the remediation materials generated by the cleanup have been treated
or disposed of in a manner such that the organic HAP in the material no
longer have a reasonable potential for volatilizing and being released
to the atmosphere.  The exemption does not apply to a site remediation
where the only activities completed during the 30-day period are
excavating, pumping, or otherwise removing the remediation material from
the contaminated area, and then storing this material on-site (e.g., in
waste piles, tanks, or containers) to be treated or disposed at some
later date after the end of the 30-day period.  In this case, the
processes and equipment used for site remediation need to meet the
applicable air emission control requirement in subpart GGGGG (unless the
site remediation qualifies for another exemption allowed under the
rule).

	It is our intention that this exemption be used for those short-term
site remediations for which all of the remediation materials generated
by the cleanup are treated or disposed within the 30-day period to meet
the requirement that the organic HAP constituents in the materials no
longer have a reasonable potential for volatilizing and subsequent
release to the atmosphere.  However, we recognize that in some
situations where the remediation materials are shipped off-site for
treatment or disposal, special circumstances beyond the direct control
of the facility owner or operator may not allow the final treatment or
disposal of the remediation material sent to the off-site location to be
completed within the 30-day period required to qualify for the
exemption.  To address these situations, the final amendments include a
provision allowing the facility owner or operator to qualify for the
exemption provided that all of the remediation material generated by the
cleanup is transferred off-site within the 30-day period according to
the existing requirements specified in §63.7936 of subpart GGGGG for
SEQ CHAPTER \h \r 1 remediation material transferred to another party or
shipped to another facility.  These   SEQ CHAPTER \h \r 1 requirements
apply to the off-site transfer of all remediation materials subject to
regulation under subpart GGGGG (including those units required to use
air emission controls) that   SEQ CHAPTER \h \r 1 have an average total
average volatile organic HAP (VOHAP) concentration equal to or greater
than 10 ppmw.  In addition, the date that the 30-day exemption period
ends must be documented such that the off-site facility knows the
deadline after which the requirements of subpart GGGGG apply for
remediation material received.

	Comment:  One commenter (0037) stated that facilities preparing to
cleanup contaminated soil routinely rent soil vapor
extraction/combustion systems to characterize the extent of
contamination and feasibility of soil remediation using a vapor
extraction method.  These pilot studies may take up to several days at a
single extraction well location.  As many potential extraction wells can
exist at a given facility, pilot studies may continue intermittently
greater than the 30 day period allowed to qualify for the exemption.
Therefore, pilot study activities should not be considered a remediation
activity; rather, pilot studies should be considered
“characterization” prior to remediation.  The commenter requested
that §63.7884(b) include an exemption for “pilot study” activities
at various locations at a facility as long as the total time period at a
single location (single sample well or defined remediation area) does
not exceed 30 days.

	Response:  The 30-day site remediation exemption is intended to be used
for those short-term site remediations for which all of the remediation
materials generated by the cleanup can receive final treatment or
disposal within the 30-day period.  The existing rule does not count as
part of the 30-day exemption period activities to characterize the type
and extent of the contamination by collecting and analyzing samples;
activities to obtain permits from Federal, State, or local authorities
to conduct the site remediation; activities to schedule workers and
necessary equipment; and activities to arrange for contractor or third
party assistance in performing the site remediation.  The exclusion of
these specified activities from not being counted as part of the 30-day
exemption period are appropriate and sufficient to characterize the
extent of the site contamination and prepare for the type of site
remediations that we intend the 30-day site remediation exemption to be
applied.  We do not intend the exemption to be used for those site
remediations requiring on-site pilot studies to select the treatment
methods, map the contaminated area boundaries, or otherwise prepare for
subsequent full-scale cleanup activities.

	Comment:  One commenter (0037) stated that the requirement under
§63.7884 (b)(2) seems to imply that site remediations, where only the
treatment and/or disposal of the remediation material exceeds 30 days,
need only comply with the §63.7936 requirements.  The commenter
recommended that the provision should read “If a remediation material
is to be shipped or otherwise transferred to an offsite facility where
the final treatment or disposal of the material cannot be completed
within the 30-day period, then management of the remediation material
must comply with all applicable provisions of this subpart.”

	Response:  The 30-day exemption under §63.7884 (b) only exempts site
remediations at a facility with affected sources subject to regulation
under subpart GGGGG and can be completed within 30-days from having to
meet the air emission control requirements specified in the rule.  It
does not exempt these site remediations from having to comply with other
applicable provisions in the rule.  Section 63.7936 of subpart GGGGG
specifies the requirements for all   SEQ CHAPTER \h \r 1 remediation
material generated by a site remediation activity subject to subpart
GGGGG and transferred from the facility where the site remediation is
conducted to another party or shipped to another facility.  These   SEQ
CHAPTER \h \r 1 requirements provide the owner or operator of the
affected facility from which the remediation material is transferred
with several compliance alternatives.  Remediation material generated by
a site remediation qualifying for the 30-day site remediation exemption
that is transferred off-site for treatment or disposal must be
transferred to a facility in compliance with the §63.7936 requirements.

	Comment:  One commenter (0047) stated that in cases when owners and
operators using the 30-day site remediation exemption ship the
remediation material off-site for final disposal, the owner or operator
of the off-site facility receiving the material would not know when the
30-day period begins.  While the waste generator is required to prepare
and maintain at the facility, written documentation of the remediation
with the listed initiation and completion dates, there does not appear
to be any requirement for the waste generator to notify the receiving
facility of the initiation date of the 30-day period allowable for the
exemption.  Because of the short time frame allowed in the exemption for
performing the remediation and completing the disposal, the receiving
facility would also need to know this information to ensure that
disposal could be completed by the 30th day.  The commenter suggests
that the final rule formalize a mechanism whereby the generator provides
the receiving notification of the start of the 30-day period by
requiring that this information be recorded on the remediation material
shipping paper(s).

	Response:  We agree that it is important that the owner or operator
receiving the remediation material be informed of the specific exemption
period for the site remediation (i.e., the initiation date and
corresponding 30-day completion date) to allow the final treatment or
disposal of the remediation material to be completed as promptly as
possible to meet the intent of the exemption.  Therefore, the final
amendments add to the 30-day exemption a requirement to include in the
appropriate waste manifest documents or other applicable shipping
documentation, in addition to the notifications and certifications
required under §63.7936, a statement that the shipped material was
generated by a site remediation subject to requirements under §63.7884
(b).  The statement must include the date on which the facility owner or
operator initiated the site remediation activities generating the
shipped remediation materials, as specified in paragraph §63.7884
(b)(1)(i), and the date 30 calendar days following this initiation date.

2.3  Air Emission Control Requirements

2.3.1  Point of Determination of Remediation Material VOHAP
Concentration

	Comment:  Several commenters (0037, 0039, 0042, 0043) supported using
the point of determination language EPA originally proposed for the rule
(67 FR 49408) to replace requirement in the final rule that the point of
determination for measuring the VOHAP concentration for the remediation
material be the “point-of-extraction.”  Placing the point of
determination for the average total VOHAP concentration of the
remediation material at a point prior to, or within, a remediation
material management unit simplifies the determination procedure and
allows flexibility in the treatment and management processes.

	Response:  Subpart GGGGG applies the air emission control requirements
for remediation material management units (i.e., tanks, surface
impoundments, containers, oil/water separators, organic/water separators
and transfer systems) to those units that manage remediation material
with an average VOHAP concentration equal to or greater than 500 ppmw.
The final amendments revise the applicable regulatory language in
subpart GGGGG referring to the point at which the facility owner or
operator determines the average VOHAP concentration of a remediation
material.  These final amendments implement our original intended VOHAP
determination procedure by reinstating the regulatory language and
terminology we originally proposed for rule, and removing the term
“point-of-extraction” from the rule.

 	Under the amended Subpart GGGGG, the facility owner or operator is
required to determine the average total VOHAP concentration of the
remediation material at a point prior to, or within, a remediation
material management unit.  Thus, once the VOHAP concentration for a
remediation material has been determined to be less than 500 ppmw, all
remediation material management units downstream from the point of
determination that manage this material are no longer required to meet
the air emission control requirements in subpart GGGGG unless a
remediation process is used that concentrates all, or part of, the
remediation material being managed in the unit such that the VOHAP
concentration of the material increases to 500 ppmw or more.

2.3.2  Requirements for Remediation Material Management Units

		Comment:  One commenter (0037) stated that under the proposed
amendments to §63.7886(b)(2), once determination of VOHAP concentration
has been made, all remediation material management units downstream of
the determination point may use this determined concentration level
unless “a remediation process is used to concentrates all, or part of,
the remediation material being managed in the unit such that the VOHAP
concentration of the material could increase (e.g., free-product
separation).”  The commenter stated that the term “free-product
separation” used for the proposed rule language seems to imply that
recovered free product from a remediation material management unit, such
as a corrugated plate interceptor (CPI) separator used to treat
extracted contaminated groundwater at a site, would be considered a
remediation material rather than a product/commodity.  Consequently, all
downstream units processing this recovered free product (e.g.,
refinery/chemical manufacturing processes) would be subject to subpart
GGGGG.  As free product consists mainly of hydrocarbon material, the
reference to free product separation in the proposed rule language is
not consistent with the rule definition of “remediation material”.
Under §63.7957, remediation material is defined as a material that
“…is made up primarily of media…”  The commenter recommended
modifying the wording under §63.7886(b)(2) to reflect that free
products or other materials from free-product separation that do not
consist mostly of “media” are not subject to the requirements of
this rule.

	Response:  The final amendments clarify that any free product returned
to a manufacturing process from a remediation material management unit
is no longer subject to the air emission control requirements in subpart
GGGGG.

2.3.3  Requirements for Equipment Leaks

		Comment:  Several commenters (0038, 0042, 0043) support EPA’s
proposed addition of a compliance option in §63.7887(b) allowing
affected sources to use leak detection and repair (LDAR) programs that
comply with any other applicable standard under 40 CFR parts 61 or 63.
This provision will ensure that owners and operators routing remediation
streams to existing control devices subject to other NESHAP will not be
burdened with overlapping LDAR requirements.

	Response:  The final amendments add a compliance option to the subpart
GGGGG air emission control requirements for those affected equipment
leak sources already using air emission controls or work practices to
comply with another subpart under 40 CFR part 61 or 63.  Under this
option, the affected source is in compliance with subpart GGGGG if the
HAP emissions from the equipment leak affected source are controlled in
compliance with the standards specified in the other subpart in part 61
or 63 that is applicable to the source.  The final amendments extend the
same compliance option that subpart GGGGG already allows for affected
process vent and remediation material management unit sources to
affected equipment leak sources.

2.3.4  Requirements for Process Vents

		Comment:  One commenter (0037) stated that §63.7890(b) allows process
vents to be controlled to a level not to exceed certain mass emissions
rates or to a minimum of ≥95% control.  At some facilities where
remediation activities to clean up large quantities of material are
performed, the mass emissions limits are not feasible to maintain.
Additionally, vendors are not able to guarantee control ≥95% for high
volume, low concentration air streams; vendor guarantees typically are
worded to read that emissions reductions will be ≥95% or to a lower
limit of XX ppmv (~20-40 ppmv as methane is typical).  The commenter
recommended modifying either §63.7885(c)(1)(ii) to remove the
volumetric flow rate limit (maintain less than 20 ppmv) or modify
§63.7890(b) to allow ≥95% or to a lower limit of 40 ppmv.

	Response:  Comment does not pertain to the amendments proposed for
subpart GGGGG.

2.4  Compliance Requirements

2.4.1  Requirements for Remediation Material Sent Offsite

	Comment:  Two commenters (0042, 0043) stated that the preamble to the
proposed amendments clarifies that the 10 ppmw average total VOHAP
concentration value for remediation material transferred offsite is to
be interpreted not as a treatment standard but rather a threshold at
which some action may be required under this rule.  The proposal
preamble (71 FR 25535-25536) stated that the 10 ppmw action level simply
means that “some action” may be required by both the transferring
facility and the receiving facility.  The commenters requested that the
preamble clarification discussion also be included in final rule
language.

	Response:  The requirements for owners and operators transferring
remediation material, having an average VOHAP concentration of 10 ppmw
or greater, to an off-site facility are specified in §63.7936 of
subpart GGGGG.  We did not propose to amend the existing language in
§63.7936, but did include an explanation in the preamble to the
proposed amendments as guidance on how the 10 ppmw action level is
applied to remediation material transferred off-site.  We specifically
selected this approach because we concluded that the existing rule
language for the provision does not require revision but publishing
additional guidance on implementing the provision would be helpful to
facility owners and operators.

2.4.2	Startup, Shutdown, and Malfunction Plan (SSMP) Requirements

	Comment:  One commenter (0040) stated that the standards in subpart
GGGGG provide owners and operators an alternative compliance option for
affected sources already using air emission controls pursuant to another
applicable subpart in 40 CFR part 61 or part 63.  The commenter
requested that EPA confirm for a source already complying with standards
in Part 61 that the source is not required to meet the SSMP required in
subpart A of Part 63.

	Response:  For affected process vent, remediation material management
unit, and equipment leak sources required by subpart GGGGG to use air
emission controls or work practices, but already using such measures to
comply with another subpart under 40 CFR part 61 or 63, the affected
source is in compliance with subpart GGGGG if the HAP emissions from the
affected source are controlled in compliance with the standards
specified in the other subpart in part 61 or 63 that are applicable to
the source.  In those cases when the affected source is controlled in
compliance with applicable standards under subpart in 40 CFR part 61,
then the corresponding general provisions in 40 CFR part 61 apply to the
affected source.

	Comment:  One commenter (0043) stated that EPA recently issued a final
rule relating to the SSMP provisions in the General Provisions and made
corresponding changes in NESHAP rules including 40 CFR subpart GGGGG (71
FR 20446, April 20, 2006).  The commenter requested that these
amendments now be incorporated into the final subpart GGGGG rule and
provided suggested rule language to be added.

	Response:  Provisions in subpart GGGGG related to startup, shutdown,
and malfunction requirements have been revised, as appropriate, to be
consistent with the amendments to the General Provisions in subpart A
under 40 CFR part 63 that we promulgated on April 20, 2006.

2.5  Other Comments

2.5.1 	Including Methyl Ethyl Ketone as a HAP in Subpart GGGGG Table 1

		Comment:  Several commenters (0039, 0043) requested that methyl ethyl
ketone (MEK) be deleted from the Table 1 list of HAPs since EPA has
formally de-listed methyl ethyl ketone (MEK) as a HAP (70 FR 75047,
December 19, 2005).

	Response:  For purposes of implementing the requirements of subpart
GGGGG, Table 1 in the rule lists the specific organic chemical
compounds, isomers, and mixtures that are HAP.  The final amendments
update this table to be consistent with EPA’s current HAP list.  The
final amendments remove from Table 1 the listings for 1,1-dimethyl
hydrazine and MEK.  Both of these organic chemical compounds have been
delisted as HAP.

2.5.2 	Rule Editorial Corrections

		Comment:  One commenter (0037) identified and requested the following
editorial and cross-reference corrections be made to the proposed rule
language.

§63.7938(b)(2): Refers to documentation required in §63.7886(c)(2).
This reference is incorrect and should refer to §63.7885(c)(2).

§63.7918(d)(2): Refers to inspection requirements in §63.7918(c).
This reference is incorrect and should refer to §63.7917(c).

§63.7918(d)(3): Refers to inspection requirements in §63.7918(e).
This reference is incorrect and should refer to §63.7917(e).

§63.7941(h): Refers to Method 21 inspections for Container Level 1
controls according to the requirements in §63.925(a).  This is the only
citation where Method 21 inspections are indicated for Container Level 1
controls.  The reference to Method 21 inspections is incorrect and
should actually refer to §63.926(a) visual inspection requirements.

§63.7950(c): Requires notification of initial startup of a new affected
source within 120 days of startup and references §63.9(b)(3).  This
reference is incorrect; the correct reference is §63.9(b)(4)(v) or
§63.9(b)(5)(ii) which only allow for 15 days.

Table 3 citation §63.8(c)(6): Erroneously refers to CPMS requirements
in §63.7900 and §63.7913.  This reference is incorrect and should
refer to §63.7927.

Proposed §63.7884(b)(2): Incorrectly references itself in the statement
“for the purpose of complying with this paragraph (b)(2).” This
reference should refer to paragraph (b) only, not (b)(2).

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nd several cases where the subpart GGGGG paragraph cited was not the
correct requirement that we had intended to the implemented by the
facility owner or operator.  For these cases, we revised the
cross-reference citations in the final amendments to cite the correct
provision in subpart GGGGG that we had intended to be referenced.  Also,
the final amendments correct terminology, typographical, and grammatical
errors in specific provisions of subpart GGGGG that have been identified
since the rule was originally promulgated.  These final amendments
replace the rule language with the correct cross-reference citation,
term, or wording, but do not change any of the technical or
administrative requirements of the rule.

 PAGE

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[Federal Register Volume 82, Number 168 (Thursday, August 31, 2017)]
[Proposed Rules]
[Pages 41364-41365]
[FR Doc No: 2017-18464]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 117

[Docket No. FDA-2016-D-2343]

Hazard Analysis and Risk-Based Preventive Controls for Human
Food: Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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

SUMMARY: The Food and Drug Administration (FDA, we, or Agency) is
announcing the availability of another draft chapter of a multichapter
guidance for industry entitled ``Hazard Analysis and Risk-Based
Preventive Controls for Human Food: Guidance for Industry.'' This
multichapter draft guidance is intended to explain our current thinking
on how to comply with the requirements for hazard analysis and risk-
based preventive controls under our rule entitled ``Current Good
Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive
Controls for Human Food.'' The newly available draft chapter is
entitled ``Chapter Six--Use of Heat Treatments as a Process Control.''

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that we consider your comment on this draft
guidance before we issue the final version of the guidance, submit
either electronic or written comments by February 27, 2018.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-D-2343 for ``Hazard Analysis and Risk-Based Preventive
Controls for Human Food: Guidance for Industry.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff office between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to
Office of Food Safety, Center for Food Safety and Applied Nutrition,
Food and Drug Administration (HFS-300), 5001 Campus Dr., College Park,
MD 20740. Send two self-addressed adhesive labels

to assist that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Jenny Scott, Center for Food Safety
and Applied Nutrition (HFS-300), Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353)
enables FDA to better protect public health by helping to ensure the
safety and security of the food supply. It enables FDA to focus more on
preventing food safety problems rather than relying primarily on
reacting to problems after they occur. FSMA recognizes the important
role industry plays in ensuring the safety of the food supply,
including the adoption of modern systems of preventive controls in food
production.
    Section 103 of FSMA amended the Federal Food, Drug, and Cosmetic
Act (FD&C Act), in section 418 of the FD&C Act (21 U.S.C. 350g), by
adding requirements for hazard analysis and risk-based preventive
controls for establishments that are required to register as food
facilities under our regulations, in 21 CFR part 1, subpart H, in
accordance with section 415 of the FD&C Act (21 U.S.C. 350d). We have
established regulations to implement these requirements within part 117
(21 CFR part 117).
    In the Federal Register of August 24, 2016 (81 FR 57816), we
announced the availability of several chapters of a multichapter draft
guidance for industry entitled ``Hazard Analysis and Risk-Based
Preventive Controls for Human Food.'' We now are announcing the
availability of an additional draft chapter of this multichapter
guidance for industry. We are issuing the draft guidance consistent
with our good guidance practices regulation (21 CFR 10.115). The draft
guidance, when finalized, will represent the current thinking of FDA on
this topic. It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternate approach if it
satisfies the requirements of the applicable statutes and regulations.
This guidance is not subject to Executive Order 12866.
    The multichapter draft guidance for industry is intended to explain
our current thinking on how to comply with the requirements for hazard
analysis and risk-based preventive controls under part 117, principally
in subparts C and G. The chapter that we are announcing in this
document is entitled ``Chapter Six--Use of Heat Treatments as a Process
Control.''
    We intend to announce the availability for public comment of
additional chapters of the draft guidance as we complete them.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in part 117 have been approved under OMB
control number 0910-0751.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA Web site listed in the previous
sentence to find the most current version of the guidance.

    Dated: August 22, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-18464 Filed 8-30-17; 8:45 am]
BILLING CODE 4164-01-P