[Federal Register Volume 80, Number 33 (Thursday, February 19, 2015)]
[Notices]
[Pages 8926-8927]
[FR Doc No: 2015-03459]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA Docket No. FMCSA-2014-0310]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition.

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SUMMARY: FMCSA confirms its decision to exempt 66 individuals from its
rule prohibiting persons with insulin-treated diabetes mellitus (ITDM)
from operating commercial motor vehicles (CMVs) in interstate commerce.
The exemptions enable these individuals to operate CMVs in interstate
commerce.

DATES: The exemptions were effective on January 15, 2015. The
exemptions expire on January 15, 2017.

FOR FURTHER INFORMATION CONTACT: Charles A. Horan, III, Director,
Carrier, Driver and Vehicle Safety Standards,<PHONE_NUMBER>,
<EMAIL_ADDRESS>FMCSA, Room W64-224, Department of
Transportation, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
Office hours are from 8:30 a.m. to 5 p.m., Monday through Friday,
except Federal holidays.

SUPPLEMENTARY INFORMATION:

I. Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at: http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

II. Background

    On December 15, 2014, FMCSA published a notice of receipt of
Federal diabetes exemption applications from 66 individuals and
requested comments from the public (79 FR 74159). The public comment
period closed on January 14, 2015, and no comments were received.
    FMCSA has evaluated the eligibility of the 66 applicants and
determined that granting the exemptions to these individuals would
achieve a level of safety equivalent to or greater than the level that
would be achieved by complying with the current regulation 49 CFR
391.41(b)(3).

Diabetes Mellitus and Driving Experience of the Applicants

    The Agency established the current requirement for diabetes in 1970
because several risk studies indicated that drivers with diabetes had a
higher rate of crash involvement than the general population. The
diabetes rule provides that a person is physically qualified to drive a
commercial motor vehicle if that person has no established medical
history or clinical diagnosis of diabetes mellitus currently requiring
insulin for control (49 CFR 391.41(b)(3)).
    FMCSA established its diabetes exemption program, based on the
Agency's July 2000 study entitled ``A Report to Congress on the
Feasibility of a Program to Qualify Individuals with Insulin-Treated
Diabetes Mellitus to Operate in Interstate Commerce as Directed by the
Transportation Act for the 21st Century.'' The report concluded that a
safe and practicable protocol to allow some drivers with ITDM to
operate CMVs is feasible. The September 3, 2003 (68 FR 52441), Federal
Register notice in conjunction with the November 8, 2005 (70 FR 67777),
Federal Register notice provides the current protocol for allowing such
drivers to operate CMVs in interstate commerce.
    These 66 applicants have had ITDM over a range of one to 41 years.
These applicants report no severe hypoglycemic reactions resulting in
loss of consciousness or seizure, requiring the assistance of another
person, or resulting in impaired cognitive function that occurred
without warning symptoms, in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the past 5 years. In each case,
an endocrinologist verified that the driver has demonstrated a
willingness to properly monitor and manage his/her diabetes mellitus,
received education related to

diabetes management, and is on a stable insulin regimen. These drivers
report no other disqualifying conditions, including diabetes-related
complications. Each meets the vision requirement at 49 CFR
391.41(b)(10).
    The qualifications and medical condition of each applicant were
stated and discussed in detail in the December 15, 2014, Federal
Register notice and they will not be repeated in this notice.

III. Discussion of Comments

    FMCSA received no comments in this proceeding.

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the diabetes requirement in 49 CFR 391.41(b)(3) if the exemption
is likely to achieve an equivalent or greater level of safety than
would be achieved without the exemption. The exemption allows the
applicants to operate CMVs in interstate commerce.
    To evaluate the effect of these exemptions on safety, FMCSA
considered medical reports about the applicants' ITDM and vision, and
reviewed the treating endocrinologists' medical opinion related to the
ability of the driver to safely operate a CMV while using insulin.
    Consequently, FMCSA finds that in each case exempting these
applicants from the diabetes requirement in 49 CFR 391.41(b)(3) is
likely to achieve a level of safety equal to that existing without the
exemption.

V. Conditions and Requirements

    The terms and conditions of the exemption will be provided to the
applicants in the exemption document and they include the following:
(1) That each individual submit a quarterly monitoring checklist
completed by the treating endocrinologist as well as an annual
checklist with a comprehensive medical evaluation; (2) that each
individual reports within 2 business days of occurrence, all episodes
of severe hypoglycemia, significant complications, or inability to
manage diabetes; also, any involvement in an accident or any other
adverse event in a CMV or personal vehicle, whether or not it is
related to an episode of hypoglycemia; (3) that each individual provide
a copy of the ophthalmologist's or optometrist's report to the medical
examiner at the time of the annual medical examination; and (4) that
each individual provide a copy of the annual medical certification to
the employer for retention in the driver's qualification file, or keep
a copy in his/her driver's qualification file if he/she is self-
employed. The driver must also have a copy of the certification when
driving, for presentation to a duly authorized Federal, State, or local
enforcement official.

VI. Conclusion

    Based upon its evaluation of the 66 exemption applications, FMCSA
exempts the following drivers from the diabetes requirement in 49 CFR
391.41(b)(10), subject to the requirements cited above (49 CFR
391.64(b)):

Eric D. Ambler (WI)
Clay B. Anderson (IL)
Gregory C. Bartley (PA)
Aaron M. Batts (NC)
Nathan R. Batzel (MN)
Michael R. Bell (MD)
Andrew P. Coffey (CT)
Robert N. Coury (NV)
Jerry A. Cox, Sr. (LA)
Lloyd F. Cuckow (CO)
Kenneth B. Dennard (GA)
Eric Q. Dickerson (IN)
James P. Dreifuerst (WI)
Billy D. Dryer (MO)
James H. Elliott (OH)
Domenic R. Folino (PA)
Jimmie W. Grist (ID)
Scott M. Guyette (WI)
Carl D. Hall (KY)
Howard M. Hammel (NJ)
Derrick D. Harris (IL)
Terry M. Jacobson (WI)
Kevin R. Johnson (MI)
Martin S. Kiss (IL)
Robert S. Krueger (WA)
David J. Long (PA)
Michael R. Ludowese (MN)
David P. Magee (MO)
Gary F. Marson (WI)
Steven R. Mc Clain (IL)
Arthur D. McFadden, Sr. (IA)
Elbert J. Means (SC)
James A. Meridith (MI)
Richard A. Moore (PA)
Keith B. Muehler (ND)
John K. Murray (NY)
Harold N. Myers (IA)
Clayton L. Neuhauser (ND)
Eugene E. Patterson, III (TX)
John D. Pede, Jr. (PA)
Jack E. Pollock (GA)
John F. Prophet (FL)
David M. Pullen (VA)
Dominic F. Quartullo (WI)
David Quintrall (WY)
Michael E. Reed (IA)
Carlos B. Rodriguez (NY)
Marvin A. Ryan (IN)
David J. Sierra (NJ)
Larry D. Small (NJ)
Roger E. Smith (IA)
Terrell W. Smith (PA)
Anthony L. Spratto (WI)
Timothy R. Stephens (KS)
Howard C. Stines (TN)
Christopher E. Swanson (CA)
Scott R. Swisher (KS)
Diana C. Tabala (NY)
Brewster E. Thurston (VT)
Phillip J. Ulmer (LA)
Charles A. Walker (IL)
Roger L. Watt (PA)
John D. Weaver (WY)
Avery White (GA)
Leroy D. Yost (IA)
Wayne W. Zander (SD)

    In accordance with 49 U.S.C. 31136(e) and 31315 each exemption is
valid for two years unless revoked earlier by FMCSA. The exemption will
be revoked if the following occurs: (1) The person fails to comply with
the terms and conditions of the exemption; (2) the exemption has
resulted in a lower level of safety than was maintained before it was
granted; or (3) continuation of the exemption would not be consistent
with the goals and objectives of 49 U.S.C. 31136(e) and 31315. If the
exemption is still effective at the end of the 2-year period, the
person may apply to FMCSA for a renewal under procedures in effect at
that time.

    Dated: February 10, 2015.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2015-03459 Filed 2-18-15; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register: July 17, 2008 (Volume 73, Number 138)]
[Notices]
[Page 41064-41065]
[DOCID:fr17jy08-58]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL08-75-000]

PacifiCorp; Notice of Filing

July 10, 2008.
    Take notice that on July 3, 2008, PacifiCorp tendered for filing a
Petition for Declaratory Order for Incentive Rate Treatment approving
specific incentive rate treatments for PacifiCorp's Energy Gateway
Transmission Expansion Project.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of

the Commission's Rules of Practice and Procedure (18 CFR 385.211,
385.214). Protests will be considered by the Commission in determining
the appropriate action to be taken, but will not serve to make
protestants parties to the proceeding. Any person wishing to become a
party must file a notice of intervention or motion to intervene, as
appropriate. Such notices, motions, or protests must be filed on or
before the comment date. On or before the comment date, it is not
necessary to serve motions to intervene or protests on persons other
than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on July 24, 2008.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-16298 Filed 7-16-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 106 (Tuesday, June 3, 2014)]
[Notices]
[Pages 31951-31952]
[FR Doc No: 2014-12808]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-E-0594]

Determination of Regulatory Review Period for Purposes of Patent
Extension; XIAFLEX

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for XIAFLEX and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of Patents
and Trademarks, Department of Commerce, for the extension of a patent
which claims that human biological product.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions (two copies are required) and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit petitions electronically to http://www.regulations.gov at Docket
No. FDA-2013-S-0610.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of
Management, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6257, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Pub. L. 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human biological product and
continues until FDA grants permission to market the biological product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of U.S. Patents and
Trademarks may award (for example, half the testing phase must be
subtracted as well as any time that may have occurred before the patent
was issued), FDA's determination of the length of a regulatory review
period for a human biological product will include all of the testing
phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human biologic product XIAFLEX
(collagenase clostridium histolyticum). XIAFLEX is indicated for
treatment of adult patients with Dupuytren's contracture with a
palpable cord. Subsequent to this approval, the U.S. Patent and
Trademark Office received a patent term restoration application for
XIAFLEX (U.S. Patent No. RE39941) from Auxilium Pharmaceuticals, Inc.,
and the U.S. Patent and Trademark Office requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated March 11, 2013, FDA advised the U.S. Patent and Trademark
Office that this human biological product had undergone a regulatory
review period and that the approval of XIAFLEX represented the first
permitted commercial marketing or use of the product. Thereafter, the
U.S. Patent and Trademark Office requested that FDA determine the
product's regulatory review period.
    FDA has determined that the applicable regulatory review period for
XIAFLEX is 5,278 days. Of this time, 4,937 days occurred during the
testing phase of the regulatory review period, while 341 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: August 24,
1995. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on August 24,
1995.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): February 27, 2009. FDA has verified the
applicant's claim that the biologics license application (BLA) for
XIAFLEX (BLA 125338) was initially submitted on February 27, 2009.
    3. The date the application was approved: February 2, 2010. FDA has
verified the applicant's claim that BLA 125338 was approved on February
2, 2010.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 1,806 days of
patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by August 4, 2014. Furthermore, any interested person
may petition FDA for a determination regarding whether the applicant
for extension acted with due diligence during the regulatory review
period by December 1, 2014. To meet its burden,

the petition must contain sufficient facts to merit an FDA
investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-
42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written or
electronic petitions. It is only necessary to send one set of comments.
Identify comments with the docket number found in brackets in the
heading of this document. If you submit a written petition, two copies
are required. A petition submitted electronically must be submitted to
http://www.regulations.gov, Docket No. FDA-2013-S-0610. Comments and
petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: May 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12808 Filed 6-2-14; 8:45 am]
BILLING CODE 4160-01-P


> Airgas comments that the demand for HCFC-22 has changed from the estimate EPA used in 2008/9 and has continued to drop each year. Airgas believes that since the supply continued to exceed demand, pricing has continued to drop. They are concerned that the low pricing has kept some applications from switching to alternative refrigerants. Airgas further comments that individuals, contractors, and equipment manufacturers all believe that there will not be any supply shortage of HCFC-22 in the foreseeable future. Airgas believes that EPA's allowance allocations made in the 2009 Final Rule have unexpectedly resulted in an ample supply of virgin HCFC-22 in the market. They state that EPA needs to make more aggressive reductions in supply of virgin material to spur a switch to alternative refrigerants and increased reclamation. [0022]
EPA Response: See previous response in this section to NRDC.
> RemTec International is concerned that there is too much R-22 being manufactured and sold on the market, which deflates the price of R-22 to levels that make it impossible for reclaimed R-22 to compete with newly manufactured material. They would like to see an incentive based system for end-users to reclaim. RemTec International believes that there is no need to amend the HCFC Pre-charged Appliance Rule unless the supply of R-22 is substantially reduced. [0024]
EPA Response: See previous response in this section to NRDC.
> Williams & Associates comments that no reclaim facility can process recovered product anywhere near the cost of virgin product. The commenter states that all indicators suggest that there is too much HCFC-22 available in the U.S. market. They commend EPA's aggressive approach to phase-down HCFCS. They believe that EPA must consider and adjust for the effects that over supply of HCFC-22 is having throughout the industry. [0032]
EPA Response: See previous response in this section to NRDC.
 5.2	Providing allowances to reclaimers
EPA received eight comments related to providing allowances to reclaimers, four in support and four in opposition.

Four commenters believe that EPA should issue allowances to reclaimers:
> Golden Refrigerant believes that significant allowances should be provided to reclaimers. The commenter suggests that allowances could be distributed to reclaimers based on an average of their past three years reported HCFC-22 reclamation totals or some other mechanism that directs the allowances in proportion to the actual amount of reclamation being provided by the entity to directly reward reclamation actions. To help prevent "gaming" the numbers, reclaimers could be required by EPA to submit (confidentially) both a transactional list of received HCFC-22 and production tracking documents showing yields and losses. In order to promote good practices, reclaimers that are not able to provide such data should not qualify for allowances.
      Golden Refrigerant suggests a pound of consumption allowance for each pound of average reclamation yield for HCFC-22, which is approximately 10% to 15% of the total allowances for 2012, and the percentage would increase as the phaseout progresses. The reclaimers would buy the material from the manufacturers and importers, which will provide a strong incentive for the manufacturers and other allowance holders to work cooperatively with the reclamation industry. As HCFC-22 becomes scarce, the commenter believes that reclaimers will likely distribute their product back first to the wholesalers and contractors that provide the reclaimer with the recovered and used refrigerant. According to Golden Refrigerant, this will provide a strong incentive to the wholesalers and contractors to participate in good recovery practices since it will allow them greater access to supplies of HCFC-22 moving forward. Therefore, by providing allowances to reclaimers, all parties will have their best interests aligned with EPA in addition to strengthening the reclamation industry, fostering a competitive environment for reclamation, and leading to a smoother transition from HCFCs. [0054]
      Golden Refrigerant notes that a large majority of the current reclaimers do not have access to any of the allocations and that most allowances are given to a few manufacturers, putting the reclamation industry in a weak position. The commenter provides a few examples of how manufacturers provide a difficult working environment for reclaimers:
         * The manufacturers exert pressure on wholesalers and contractors not to return their used refrigerants to a reclaimer, using their supply of virgin refrigerants as leverage.
         * The manufacturers seldom work cooperatively with reclaimers and often expect reclamation work to be done for a low number (50 cents/lb) that would not allow the reinvesting of any profits into new technology.
         * The manufacturers have threatened legal action against reclaimers attempting to work on newer patented blends.
         * The manufacturers have refused to sell components or allow reclaimers a method to work with them to restore fractionated blends back to specification.
         * The manufacturers have asked cylinder manufacturers not to sell pre-labeled DOT 39 cylinders for their blends to reclaimers.
         * The manufacturers will offer cash bounties to wholesalers collecting their used refrigerant but will not offer any incentive to reclaimers to do the same.
         * The manufacturers or their agents will buy an account back by offering cash for the used refrigerants higher than justified.
         * The desire of manufacturers to promote their own best self-interest results in a difficult environment for a refrigerant reclaimer to prosper.
         For these reasons, Golden Refrigerant believes that EPA should assign a portion of total pool of allowances to the reclaimers to build a strong reclamation industry that is profitable enough to make investments in the technology to fully reclaim HCFC refrigerants as well as other refrigerants. According to the commenter, EPA is only providing the main instrument of financial benefit to a portion of the needed participants.
         Further, the commenter believes it would be appropriate to subtract any stockpiles from the allowances of any of the allowance holders in their next years' allowances. Allowance holders could choose whether allowances or stockpiles serve their best interests. This would result in a more predictable supply of material into the marketplace, which would also allow EPA to better understand the market to adjust allocations moving forward.
         Golden Refrigerant comments that they are also concerned about the demand for the reclaimed product. They state that the problem occurs when there is an oversupply in the market. Because reclaimers work on a fairly low margin, it is critical to sell quickly to recover expenses and fund the next round of purchases and production. When demand is low, reclaimers are forced to lower prices, which strain the business. Therefore, the commenter suggests that EPA cuts the allocations at least to the level that the allocations plus the available amount of material coming from reclamation is less than the demand amount for 2011. [0054, 0025]
EPA Response: See section IV.B.4. of the preamble to the final rule and section 4.1 of this document for a full response to comments on this issue.
> USA Refrigerants asks that EPA gives reclaimers an opportunity and level the playing field. They comment that the acquisition price, whether imported or produced domestically, of R-22 for allocation holders has remained virtually unchanged, despite the years of touting price increases, increased manufacturing costs, shortages, etc. [0021]
EPA Response: See section IV.B.4. of the preamble to the final rule for a full response to comments on this issue.
> ICOR International believes that EPA's refusal to establish reclamation credit allocation was bad policy. They state that EPA should provide each EPA certified reclaimer, currently not holding HCFC-22 allocation, HCFC-22 consumption allocation equal to two times their previous year's HCFC-22 recovery activity. They believe this process should begin in 2012, using 2011 reclamation data and continue until 2014. [0031]
EPA Response: See section IV.B.4. of the preamble to the final rule for a full response to comments on this issue.

EPA received four comments in opposition of issuing allowances to reclaimers:
> NRI does not believe that EPA should issue allowances to reclaimers. There is no precedent for EPA to do so. The commenter states that advocating the blending of newly manufactured refrigerant with used refrigerant is irresponsible and will adversely affect the reputation of reclaimed refrigerant. Further, they state that it does not make economic sense to dilute the supply of newly manufactured refrigerant. NRI disagrees with EPA's assertion that "reclaiming without significant blending further increases the costs of reclamation." The commenter believes that if a reclaimer cannot properly remove impurities in used refrigerant, it should be sent to a reclaimer to destroy it. [0068]
EPA Response: See section IV.B.4. of the preamble to the final rule for a full response to comments on this issue.
> Honeywell does not support the allocation of allowances to reclaimers. According to the commenter, to provide allowances to reclaimers would give them the ability to contaminate virgin product with recovered (but not reclaimed) material and then sell this blend for use. The commenter believes that EPA should not encourage such actions, and that reclaimers need to upgrade recovered material to specification by reclamation, not by blending contaminants to a lower concentration through the use of virgin-22.
      Moreover, for several reasons, Honeywell does not believe that allocations of consumption allowances to reclaimers will have the effect of encouraging greater recycling and reclamation in the marketplace. First, Honeywell believes that sufficient reclamation capacity to meet greater future demand already exists today, and is aware of several reclaimers, including Honeywell, with capacity to accept large additional future volumes of reclamation material. Second, Honeywell notes that additional consumption allowances are not needed by reclaimers, because virgin HCFC-22 is not required to reclaim product. Reclamation of product can easily be accomplished by distillation processes that do not require the use of virgin HCFC-22. Finally, Honeywell states that allocating allowances to reclaimers creates a myriad of administrative and practical problems. EPA would face difficult questions relating to the amount of allowances to allocate, to whom it should allocate those allowances, and how to prevent the virgin HCFC-22 produced or imported with "Reclamation" allocation from simply being sold in the marketplace. Honeywell expresses concern that developing, vetting, and implementing these new procedures would only further delay the Final Rule.
      Honeywell believes the continued success of efforts to encourage more recycling and reclamation does not depend upon the capacity of the reclamation industry (of which there already is plenty), but instead depends upon incentives for users to recycle and send more product for reclamation. This has been accomplished by limiting the proposed number of HCFC-22 allowances to a volume that is well short of EPA demand estimates. Honeywell believes the EPA's current proposal fully encourages recycling and reclamation and there is no need to allocate allowances to reclaimers. [0082]
EPA Response: See section IV.B.4. of the preamble to the final rule for a full response to comments on this issue.
> DuPont does not support providing allowances to reclaimers. DuPont comments that it is clear from the definition of "refrigerant reclamation" contained in a report referenced in the Proposed Rule that blending used HCFC-22 with new HCFC-22 is not reclamation. DuPont comments that it is critical that the reclamation industry be ready for the 2020 elimination of HCFC-22 consumption by developing the infrastructure to reclaim HCFCs. DuPont believes that providing allowances to reclaimers would be counterproductive in achieving this objective. [0070]
EPA Response: See section IV.B.4. of the preamble to the final rule for a full response to comments on this issue.
> HARDI believes that refrigerant reclaimers should not be provided allowances. HARDI states it is supportive of refrigerant reclamation and maintains that the EPA should continue to support reclamation through distillation, which is a much more viable option in the long run and does not require allocation rights for refrigerant reclaimers. [0069]
EPA Response: See section IV.B.4. of the preamble to the final rule for a full response to comments on this issue.
> Arkema comments that new entrants to the HCFC market should not receive HCFC allowances. Arkema is not aware of any reason to believe that the market has prevented any party, including especially blenders, from acquiring unused allowances at a fair price. Given the assumption that the market is saturated with HCFC-22, there is no reason to suspect that allowance holders would rather keep and allow allowances to expire than to sell them. Arkema notes that it has not been in a position to sell allowances in 2010 and 2011. [0073]
EPA response: See section IV.B.4. of the preamble to the final rule for a full response to comments on this issue.

 5.3	Providing allowances to manufacturers of HCFC blends
EPA received five comments on the provision of allowances to manufacturers of HCFC blends. Four commenters are opposed while one commenter, on the Interim Final Rule, would like EPA to consider redistribution of allowances to assist small HCFC blenders.
> NRI does not believe that EPA should issue allowances to manufacturers of HCFC blends. The commenter notes EPA's provision for new entrants when establishing the HCFC allocation system in 2003, and states that this provision plus EPA's intent to accelerate the phaseout of HCFC-22 does not support a request to increase the overall allocation. [0068]
EPA Response: See section IV.B.4. of the preamble to the final rule for a full response to comments on this issue.
> Honeywell does not support providing allowances to manufacturers of HCFC blends. Blend preparers are not manufacturers and have no history of production or consumption. In Honeywell's experience, these entities have been able to obtain HCFCs  -  in fact; Honeywell has been a supplier to parties involved in such blending operations. Honeywell believes blend preparers should experience the same market dynamics as the rest of the user community. [0082]
EPA Response: See section IV.B.4. of the preamble to the final rule for a full response to comments on this issue.
> DuPont does not support providing additional allowances to manufacturers of HCFC blends. DuPont notes that some manufacturers of HCFC blends have baseline allowances and would have HCFC allowances under any of the options in the Proposed Rule. For any other company, DuPont supports the agency's conclusion that "[c]ompanies can transfer allowances between companies and, on a temporary basis, between chemicals ... [and] can also purchase HCFCs at the wholesale price." DuPont notes that others are not prevented from entering the market but can purchase HCFC baseline allowances in accordance with the established practices. [0070]
EPA Response: See section IV.B.4. of the preamble to the final rule for a full response to comments on this issue.
> Arkema comments that new entrants to the HCFC market should not receive HCFC allowances. Arkema is not aware of any reason to believe that the market has prevented any party, including especially blenders, from acquiring unused allowances at a fair price. Given the assumption that the market is saturated with HCFC-22, there is no reason to suspect that allowance holders would rather keep and allow allowances to expire than to sell them. Arkema notes that it has not been in a position to sell allowances in 2010 and 2011. [0073]
EPA response: See section IV.B.4. of the preamble to the final rule for a full response to comments on this issue.
> ICOR International requests an updated recalibration of allowances, recognizing that millions of pounds of U.S. HCFC allowances are left unused every year. They believe that EPA's current allocation system puts small firms that are producing HCFC refrigerant blends out of business. [0031]
EPA Response: See section IV.B.4. of the preamble to the final rule for a full response to comments on this issue.

 5.4	Potential impacts of the proposed rule on small entities and consumers
EPA received 33 comments expressing concern about the impact of the proposed rule on small entities and consumers.
> Goodman comments that if the proposed rule is made final, American consumers would find it increasingly difficult and more expensive to service their existing HCFC-22 systems, and in many instances would be forced to purchase new, more expensive systems that use a different refrigerant. Goodman does not believe that EPA should promulgate a Final Rule on allowances that penalizes consumers who want to service existing equipment.
      Goodman comments that EPA's proposed rule is creating uncertainty and chaos within the industry, and increasing costs to American consumers. Goodman notes that the first few months of every year is the period during which air conditioning manufacturers ramp up production for the coming cooling season. The increased uncertainty as to the availability of HCFC-22 is making the manufacturing process much more difficult to manage and speculative, which Goodman believes is inconsistent with EPA's desire for a "smooth transition" away from HCFC-22.
      Goodman comments that American businesses that utilize HCFC-22 equipment, as well as consumers who need to service their existing HCFC-22 systems, will bear the brunt of these higher prices. Goodman notes that if industry stakeholders do not have adequate assurances regarding the availability of HCFC-22 in 2012 and beyond, distributors and installers will increasingly recommend the installation of more costly air conditioning systems that utilize other refrigerants. Goodman believes that by accelerating the phase-down of HCFC-22 allowances, EPA's proposed rule would make the repair and servicing of existing HCFC-22 systems much more expensive and difficult, which is at cross purposes with the interests of American consumers. [0084]
EPA Response: While EPA does not set the price, the agency is aware that the price of HCFC-22 has risen. As explained in the preambles to the proposed rule and the final rule, EPA proposed adjustments in the HCFC-22 consumption allocation because of industry feedback and data. Ample existing supply and low price were not encouraging transition to alternatives or recovery and recycling of existing refrigerant. EPA notes that the phaseout schedule is already in place and that the agency is not altering it. This final rule simply prepares industry and consumers for the 2015 stepdown, and the complete HCFC-22 phaseout in 2020. EPA is striving to encourage a smooth transition out of HCFC-22 over time and believes that a smooth transition is supported by strong incentives to properly manage and recover refrigerant, which is less likely to happen when the value of the refrigerant is low. The allocation in the final rule balances the needs of consumers to service their air conditioning and refrigeration systems while also incentivizing greater recovery and recycling of HCFC-22 and transition to non-ODS alternatives. The continued allocation of allowances for production and import for servicing existing equipment helps consumers and small businesses who cannot currently afford to buy new equipment. Additionally, the final rule relieves the regulatory uncertainty that some commenters feel was linked to price fluctuations, and the final rule also allows for an amount of consumption (i.e., production and import for U.S. use) that is above the minimum proposed allocation.
> Mayeaux's A/C & Heating, Inc. commented that small businesses as well as end-users would be hurt by decreasing current production allowances. The commenter further states that decreasing current production allowances will result in an aggressive push of the market for R-410A. [0093]
EPA Response: See previous response in this section to Goodman.
> One commenter is concerned about the cost increases associated with further production restrictions. They state restrictions will cause hardships to low and middle class citizens and state "the small people need a break." [0128]
EPA Response: See previous response in this section to Goodman.
> One commenter noted that further restrictions on HCFC-22 production will cause unnecessary hardships to citizen, as they pay inflated costs for R-22 repair. [0130]
EPA Response: See previous response in this section to Goodman.
> One commenter is concerned about the economic burden on landlords and tenants that may result from a decrease in current production allowances. The commenter asks that EPA considers how this action could increase the cost of housing. [0105]
EPA Response: See previous response in this section to Goodman.
> One commenter is concerned the price escalation [of HCFC-22] will eventually find its way to the end consumer, many who are elderly and on fixed incomes and can least afford to do without air conditioning or who can absorb unnecessary price escalations. [0159]
EPA Response: See previous response in this section to Goodman.
> Mondy Global Inc. states that reducing consumption allowances would threaten small businesses like them and is not warranted by the current market situation. [0055]
EPA Response: See previous response in this section to Goodman.
> One commenter stated that the economic realities of the past few years has been difficult for small businesses and that contractors who want to follow the law find themselves at a disadvantage by those who vent. Reducing R-22 availability would increase the value of reclaimed product, thus incentivizing recovery. [0075]
EPA Response: See previous response in this section to Goodman.
> HARDI states its belief that EPA erred in limiting the production and importation on the basis of a proposed rule and this could have a negative impact on small businesses. According to the commenter, there could be financial harm and devaluation of inventory for distributors who purchased HCFC-22 during the interim period if the allocation is higher than at the level prescribed in the non-enforcement letter. [0069]
EPA Response: See previous response in this section to Goodman. EPA notes that without the No Action Assurance (which allowed limited production and import based on the minimum amounts proposed), no import or production could have occurred. Without prejudging the outcome of the final rule, EPA's No Action Assurance limited the extent of market disruption that could have otherwise occurred under a complete regulatory ban on production and import.
> One commenter stated that a reduction in production levels will impose an undue burden on many working Americans who would have to go without AC. The commenter suggested a phaseout during better economic conditions. [0141]
EPA Response: See previous response in this section to Goodman. Additionally, the rationale for the rule, as well as the requirements under the Montreal Protocol and Clean Air Act are discussed in sections III.A. and III.B. of the preamble to the final rule.
> Rocky Mountain Refrigerant Abatement, Greer Holdings, Rhynard and White Enterprises, Bettcher Enterprises, Southeast Refrigerant Recovery, and Bay Area Refrigerant Recovery comment that the economic realities of the past few years have been difficult for small businesses. Most commenters state that contractors who follow the law and recover HCFC-22 find themselves disadvantaged because venting refrigerant is easier and more profitable. The commenters encourage EPA to reduce consumption allowances to the fullest extent, to decrease the availability of HCFC-22 and increase the buyback price paid to contractors. [0052, 0056, 0058, 0059, 0074, 0075, 0080]
EPA Response: See previous response in this section to Goodman.
> One commenter urges EPA to consider the small businesses and consumers that will suffer with a large price increase on HCFC-22. [0102]
EPA Response: See previous response in this section to Goodman.
> One air conditioning contractor comments that an increased phaseout will create extreme hardship on all those with HCFC-22 systems since it is costly to change to a R-410a system due to the type of line sets, oil, etc. that must be changed when conversion to R-410a systems are installed. The contractor urges EPA to remember that R-410a components and HCFC-22 components are not interchangeable, and complete systems must be installed with new copper line sets as needed. The commenter notes that most people cannot pay for a simple HCFC-22 condenser change out, which costs significantly less than a complete system change-out conversion to R-410a. [0092]
EPA Response: See previous response in this section to Goodman.
> One commenter states that a reduction of the magnitude EPA is considering will cause great financial turmoil. Consumers have planned their change-over with the phaseout schedule as their guide. Some businesses have spent large sums of money on repairs of their HCFC-22 equipment with the phaseout schedule in mind, to get the most from their existing equipment. [0115]
EPA Response: See previous response in this section to Goodman.
> One contractor noted that economic burdens are being placed on American households at rates never seen before, and any acceleration of the impending phase out of HCFC-22 would be disastrous to the critically fragile American economy because it would cause an unnatural and unplanned shift in the market. The commenter believes the cost will ultimately be borne by the citizens as they will pay inflated cost for HCFC-22 repair. [0113]
EPA Response: See previous response in this section to Goodman.
> Three commenters state that further restrictions on HCFC-22 will cause an unnatural and unplanned shift in the market. The commenter believes the cost will ultimately be borne by citizens as they will pay inflated cost for HCFC-22 repair. [0135, 0094, 0097]
EPA Response: See previous response in this section to Goodman.
> One commenter states that running a small business is hard enough without increasing prices of consumable goods. [0094]
EPA Response: See previous response in this section to Goodman.
> Commenters from Johnstone Supply note that EPA's proposed ruling to reduce the quantity of HCFC-22 for production and import in 2012 will only hurt small businesses and consumers. The commenters urge EPA to consider that if the total amount of HCFC-22 is not produced as planned, HVAC businesses and their customers will suffer due to a large price increase on HCFC-22. [0124, 0132, 0098]
EPA Response: See previous response in this section to Goodman.
> One commenter from Johnstone Supply notes that this proposed rule not only affects distributors that have produced equipment, wholesalers inventorying stagnate product, customers buying power to allow a product at a lower cost, and the consumer having to absorb a high price in an economy that is steadily sinking. The commenter states that the whole U.S. is affected by this move. [0133]
EPA Response: See previous response in this section to Goodman.
> One commenter notes that HVAC is one of the greatest expenses a property owner has. The commenter states that raising the cost of maintenance will cause property expenses to increase, raising rents and further creating economic hardship on the ultimate consumer. [0155]
EPA Response: See previous response in this section to Goodman.
> One company comments that the cost of the phaseout presents an additional hardship to people already struggling in the current economy. [0112]
EPA Response: See previous response in this section to Goodman.
> One commenter notes that the increase in price is being paid by the consumer, which seems unfair in today's economy. The commenter believes homeowners will not be able to pay their air conditioning service bills because the fear of higher prices has driven the cost of HCFC-22 beyond reason. In the commercial market, decisions were made to retrofit or not based on the government's published plans, and changing the plans overnight after years of notification of a set schedule unduly affects all business plans. The commenter believes further production restrictions will result in unnecessary hardships to citizens. [0127]
EPA Response: See previous response in this section to Goodman.
> Two commenters note that with the difficult economic times, many consumers are opting to repair and not replace their systems. The commenter states that many of the systems in use are under warranty, so the HCFC-22 will have to be replaced, and with the current shortage and the concurrent rise in price, the cost to a consumer has now doubled to repair a unit. The commenters do not want to raise prices in these economic times [0095, 0136]
EPA Response: See previous response in this section to Goodman.
> One commenter notes that reducing production of HCFC-22 will place an undue and perhaps unmeant burden on the consumer. The commenter notes that this will be an especially hard burden on lower income individuals who cannot afford to switch over to another refrigerant and should not have to if their unit is still under warranty [0095].
EPA Response: See previous response in this section to Goodman.
> One commenter is concerned with how the rulemaking will affect the lower and middle class U.S. citizens. They state that after the ruling was made, the price of HCFC-22 greatly increased in just one day primarily affecting those who cannot afford to switch systems. They believe that EPA is disconnected with these citizens. [0143]
EPA Response: See previous response in this section to Goodman.
> One commenter suggested that Nu-22B be used to avoid an expensive change in systems for the consumer. In the commenter's experience, the transition from HCFC-22 to R-410a has been very challenging in the field since a lot of citizens are not aware of the phaseout and therefore don't understand why those in the HVAC industry have no choice to change refrigerants. Further, the commenter has concerns about the safety of R-410a and the time it takes to service. The commenter also expresses concern about the welfare of citizens in warm climates and what would happen to them without AC, and suggests that environmental damage from refrigerants should not be the biggest of concerns. The commenter states that either more R-22 should be sold, or Nu-22B should be pushed as a replacement. [0104]
EPA Response: See previous response in this section to Goodman. EPA's SNAP program has approved numerous alternatives to HCFC-22 for this end use. A full list of approved alternatives is available at http://www.epa.gov/ozone/snap/refrigerants/index.html.
> ICOR International believes that the phase down total U.S. baseline HCFC production and consumption most benefited the legacy chemical producers. They state that the three companies that received approximately 90% of the total HCFC allocation would use the extraordinary competitive advantage that the HCFC allocation rule gave them to put small businesses like ICOR out of business by denying them the components to make products, or effectively reclaim HCFC refrigerants. They point out that the three producers with the majority of allocation are not using all their allocation, but now refuse to trade. ICOR International is concerned that EPA did not allow flexibility to empower small refrigerant manufacturers. [0031]
EPA Response: See section IV.B.4. of the preamble to the final rule for the full response.

 5.5	Timely completion of the rule
EPA received 18 comments related to timely completion of the rule.
> NRI comments that EPA's timing for releasing the proposed rule was a disservice to the industry that has worked tirelessly over the years with EPA to accomplish the mutually beneficial goal of protecting the ozone layer. [0068]
EPA Response: The agency recognizes the importance of regulatory certainty in order for companies to plan and be prepared for the eventual phaseout of HCFCs. The 2009 Final Rule covered HCFC allocations for 2010-2014, but was partially vacated by the D.C. Court of Appeals for the District of Columbia Circuit. In response to that partial vacatur, EPA worked as quickly as possible to issue the 2011 Interim Final Rule and the 2012-2014 Final Rule, and hopes to establish allowances for 2015-2019 well before that regulatory period begins.
> Arkema comments that EPA has created market disruptions by changing the rules mid-stream, starting with the 2009 Final Rule. The IFR set allowance levels for 2011 that did not take effect until August of that year and the current rule is not expected until later 2012. Arkema states that these types of delays have increased cost and injected unnecessary uncertainty into the economy. They believe that by failing to re-set 2012 allowances in a timely manner, EPA is denying to Solvay and Arkema the relief mandated by the D.C. Circuit. [0073, 0028]
EPA Response: See previous response in this section to NRI. EPA does not agree that the timing of this rule means it is denying Solvay and Arkema appropriate relief. Realizing that the final rule would be issued late, EPA allowed companies to produce and import at the lower end of the proposed range through No Action Assurance. That authorized amount was proportional to the baseline allowances which EPA established in the 2011 Interim Final Rule, in direct response to the Court's ruling. In addition, any costs or uncertainty associated with the timing of the 2012-14 rule fall equally on all allowance holders, not on Solvay and Arkema uniquely.
> ACCA comments that the proposed rule must be promulgated quickly to reduce the uncertainty in the market. ACCA urges EPA to send a signal to industry to communicate intentions before the summer season. [0081]
EPA Response: See previous response in this section to NRI.
> AHRI urges EPA to finalize the rulemaking as soon as feasible to avoid uncertainty and restore confidence in the marketplace. [0072]
EPA Response: See previous response in this section to NRI.
> While HARDI is supportive of EPA efforts in reducing HCFC-22, they are concerned that EPA's delay in publishing the proposed rule has negatively impacted distributors and caused a great deal of confusion. The commenter recommends that in the future, EPA should consider extending the prior year's allocation level if the rulemaking for the next control period is delayed and pro-rate the allocations established in the new rule for remainder of the new control period once the rule is complete.
      HARDI states that there are concerns within its membership that EPA's delay in publishing the proposed rule and delay in issuing non-enforcement letters has negatively impacted distributors. HARDI discourages EPA from further consideration of adjustments to caps or allocations established by this rule after its effective date. HARDI does not support retroactive enforcement actions. HARDI comments on the risk for market confusion due to the lateness of the rulemaking and encourages EPA to complete subsequent rulemakings prior to the control period which they are intended to govern.
      Further, the commenter has concerns with the non-enforcement letter process. They question why there was such a delay in providing this letter to the producers and importers of HCFC-22. The commenter believes that this three week delay in providing the non-enforcement letter to producers and importers caused market uncertainty and should have been avoided. HARDI emphasizes that this delay has caused (and continues to cause) significant harm to many HARDI members. HARDI recommends that in the future, a posting in the Federal Register, followed by a communication to all stakeholders would suffice, noting that impacts are felt in the marketplace far beyond just the allocation holders. [0069]
EPA Response: See previous response in this section to NRI. Additionally, EPA will keep HARDI's comments in mind if future No Action Assurance letters are issued to authorize production and consumption in the absence of a final rule.
> Solvay comments that a timely decision by EPA to issue recoupment allowances and make other necessary adjustments will give all market participants sufficient notice that Solvay believes they were denied in 2010. Solvay notes that EPA issued the Final Rule governing HCFC production and consumption for 2010-2014 on December 15, 2009, giving Solvay and customers less than two weeks to adjust to the loss of 90 percent of the allowances that the company had anticipated receiving. Solvay comments that a timely decision by EPA to issue recoupment allowances will provide the precise allowance shares to all participants as EPA originally intended to do over the life of the control period, and allow the market to function smoothly. [0064]
EPA Response: See previous response in this section to NRI.
> Two commenters request EPA to allow the full allocation to be produced for 2012 that was originally planned since changing the allocation at such late notice will put an unreasonable hardship on HVAC businesses and customers. [0102, 0098]
EPA Response: See previous response in this section to NRI.
> NORDYNE does not support reducing the 2012 allocation since 2012 has already started. NORDYNE notes that the possibility of reducing this allocation is already creating significant issues in the marketplace. Pricing has become extremely volatile and significant inventory concerns are commonly discussed. Manufacturers have already planned their production for 2012. NORDYNE believes that to change the rules mid-year is unfair, disruptive, and will create significant unnecessary burdens on the industry. [0089]
EPA Response: See previous response in this section to NRI. In addition, the court vacated the allocations. As a result, EPA is not changing an existing allocation but rather issuing a new allocation.
> Goodman comments that this proposed rule is tantamount to changing the rules in the middle of the game as industry stakeholders prepare to meet the next scheduled phase-down of HCFC-22 in 2015. Goodman is disconcerted that EPA is now promulgating a rule for 2012 that will not provide allowances for HCFC-22 until well into calendar year 2012. Goodman notes that if last year's experience is any guide, a final rule or interim final rule may not be published until the traditional cooling system is practically over. Goodman states that while EPA's No Action Assurance letters have given refrigerant manufactures certainty that they may permissibly produce specified quantities of HCFC-22, industry stakeholders already have seen the price of HCFC-22 double, and in the upcoming weeks and months, prices will potentially increase further. [0084]
EPA Response: See previous responses in this section to NRI and NORDYNE.
> Able Distributors, APR Supply Co. and Coburn Supply Company state their opposition to the proposed 2012 allocation reduction since 2012 has already started. According to the commenters, the possibility of reducing this allocation has already created significant issues in the market place and created price volatility. The three companies comment that manufacturers have already planned their production for 2012 and regard a change in rules to be unfair, disruptive and will create unnecessary burdens. [0147, 0148, 0149]
EPA Response: See previous responses in this section to NRI and NORDYNE.
> One commenter noted that industry has already made plans and purchases according to the guidelines that were advertised. [0130]
EPA Response: See previous responses in this section to NRI and NORDYNE.
> Golden Refrigerant suggests that EPA issue 2012 allowances as quickly as possible and review the market conditions, setting the allowances for the following years by September of the previous year. [0054]
EPA Response: See previous response in this section to NRI.
> The National Multi Housing Council (NMHC) and the National Apartment Association (NAA) call upon EPA to promulgate the final rule within 60 days to ease supply disruptions and facilitate routine maintenance on equipment before the nationwide peak demand for air conditioning. [0156]
EPA Response: See previous response in this section to NRI.
> The Food Marketing Institute (FMI) states that lack of time to assess options will lead to suboptimal results. Accelerated retrofits will likely result in higher energy usage as retailers are forced to retrofit without complete evaluation of all potential refrigerants. They believe that the pricing pressures imposed by the proposed rule will cause a rush to implement new and unproven technologies to reduce refrigerant charge. This will likely result in additional emissions due to unproven technology (e.g., micro channel condenser leaks). [0157]
EPA Response: See previous response in this section to NRI as well as the previous response to FMI in section 4.1 of this document.
> Hudson Technologies comments that further delay in the finalization of a final rule for subsequent control periods will create confusion and disruption in the industry, will adversely affect the market, and will likely further damage an already withering reclamation industry. [0027]
EPA Response: See previous response in this section to NRI.
 5.6	Compliance and enforcement issues
EPA received 13 comments regarding compliance and enforcement of regulations, generally urging EPA to increase the level of enforcement for refrigerant recovery.
> Rapid Recovery Franchise Partners comment that if there is to be a significant reduction in venting and a corresponding increase in the amount of R-22 recovered and made available for reclamation, EPA will need to significantly increase both the level of enforcement of Section 608 of the CAA and the visibility of that enforcement. As the national refrigerant recovery experts, the commenters meet every day with HVAC and demolition contractors as well as recycling and disposal companies. The commenters hear two different perspectives from these companies. Those who are complying with EPA regulations, many of whom are Rapid Recovery customers, express frustration that they are at a significant competitive disadvantage when bidding against those companies who do not comply. They believe that increased enforcement will create a level playing field. On the other hand, those who are not presently in compliance, advise Rapid Recovery that they have never been contacted by the EPA and they know of no one in their particular industry who has been.
      In the commenters' experience there are no regular audits and often the commenters are told that even when violations have been reported to the EPA, there has been no follow up. The franchise partners of Rapid Recovery note, however, that in those few situations that some enforcement or even threat of enforcement has taken place, there has been immediate and wide-spread compliance for a time. The commenters believe that if EPA desires a significant increase in both compliance and additional recovered R-22, enforcement must be a significant part of the process. [0086]
EPA Response: EPA encourages all industry participants and private citizens to report any illicit activity. EPA takes enforcement of its regulations seriously, and encourages all industry players to maintain accurate records that document appropriate handling and use of refrigerant. To report a violation online, visit http://epa.gov/tips/. Additionally, EPA's enforcement history of ODS cases can be found at http://www.epa.gov/ozone/enforce/index.html
> Certified Refrigerant Services, Inc. is concerned that participation in the reclaiming effort is taken too lightly and are not satisfied with the estimated 10% compliance with the regulations. Further, they state that money is the only real motivator for participation in the reclamation effort. [0057]
EPA Response: See previous response in this section to Rapid Recovery Franchise Partners. Additionally, see the response to NRDC in section 5.1 of this document.
> One commenter stated that enforcement is necessary for compliance with Section 608. Increased visibility of enforcement efforts may increase the level of reclamation. [0075]
EPA Response: See previous response in this section to Rapid Recovery Franchise Partners.
> Rocky Mountain Refrigerant Abatement notes that EPA should increase the level and visibility of its enforcement efforts so that contractors comply with EPA regulations to recover refrigerant. [0059]
EPA Response: See previous response in this section to Rapid Recovery Franchise Partners.
> LA Refrigerant Recovery, AZ Refrigerant Abatement, Rhynard and White Enterprises, and Houston Refrigerant Recovery, all comment that customers are best motivated to recover refrigerant by publicized enforcement. The commenter states that contractors do not believe EPA will enforce the CAA Section 608 regulations, they have never been visited by the EPA, and they believe that no one cares about venting. The commenter notes that contractors are therefore ignoring the regulations. [0051, 0053, 0058, 0060]
EPA Response: See previous response in this section to Rapid Recovery Franchise Partners.
> NRDC, IGSD, and EIA believe that the over-supply and low price of virgin HCFC-22 is undermining compliance and enforcement of current anti-venting requirements to the detriment of the atmosphere and to the detriment of the public health and the environment. [0067]
EPA Response: See previous response in this section to Rapid Recovery Franchise Partners.
> A group of 20 EPA Certified ODS Reclaimers appreciate EPA's desire to promote a viable recovery and reclamation industry. They comment that by reducing allocations, EPA and reclaimers have a joint opportunity to utilize the existing "Recovery and Reclamation Network", which is needed to meet the needs of2015 and beyond. To do this the EPA must help those who provide recovered refrigerants to reclaimers develop a "culture" of recovery for reclamation. The twenty certified refrigerant reclaimers note that EPA must enforce existing regulations, especially "no venting" rules. They comment that as a result of these efforts, a positive value for the recovered product will be established and maintained, not just in 2012, but throughout the phaseout period. [0085]
EPA Response: See previous response in this section to Rapid Recovery Franchise Partners.
> Bay Area Refrigerant Recovery comments that that any enforcement taken by the EPA has a significant impact on the industry and that the number of companies that recover refrigerants increases greatly. The commenter believes that gentle reminders of the rules and the threat of enforcement would go a long way toward increasing the amount of recovered and subsequently reclaimed refrigerants. Bay Area Refrigerant Recovery urges the EPA to consider new and creative ways in which it might engage in appropriate enforcement. Bay Area Refrigerant Recovery would welcome the opportunity to discuss some ideas with those in the San Francisco office who are responsible for this important part of the process. [0080]
   EPA Response: See previous response in this section to Rapid Recovery Franchise Partners. EPA is always interested in effective ways to improve compliance, and encourages the commenter to contact EPA headquarters to discuss ideas.
> Consolidated comments that there are three potential motivators for recovering refrigerant, the first of which is doing the right thing. The commenter believes a program similar to GreenChill that encourages government and industry partnerships that will recognize and reward good recovery practices, would lead to greater compliance and additional available recovered refrigerants. Consolidated continues that the second motivator is economic incentive (aggressive allotment adjustments which impact price will address this), and the third is enforcement by the EPA. Consolidated notes that it appears that the EPA does not have the resources necessary to police the industry. Until such time that contractors actually believe they risk enforcement and penalties, the only tangible incentive is the buyback they receive from reclamation and/or recovery companies. A letter from the EPA to stakeholders reminding them of the laws and penalties for violations would go a long way toward compliance. Consolidated believes publicized cases of enforcement on the average sized company would also result in compliance. Consolidated believes that EPA can publicize its work and enforcement through News Releases. Consolidated also believes that contractors in compliance are at a disadvantage contractors not in compliance and think enforcement would level the playing field. [0083]
EPA Response: See previous response in this section to Rapid Recovery Franchise Partners and Bay Area Refrigerant Recovery. The agency appreciates suggestions for encouraging better compliance and will consider ways it can improve compliance. EPA also lists all ODS enforcement cases at http://www.epa.gov/ozone/enforce/index.html.
> NRI agrees with EPA that refrigerant should be reclaimed using distillation and separation and encourages EPA to require third party certification of reclaimers so that consumers can have as much confidence in reclaimed refrigerant as they do newly manufactured refrigerant. [0068]
EPA Response: This comment is beyond the scope of this rulemaking. However, EPA will consider this comment as it develops future regulations. Reclaimers are currently required to follow the certification provisions in 40 CFR 82.164.
> Polar Technology believes that proper reclamation of R-22 will not occur because of the lack of enforcement. They state that technicians, contractors, and system owners do not fear that the failure to properly recover will be met with punishment; there are too many systems and technicians to monitor and hold accountable. Polar Technology cites California's AB32 that, according to the commenter, was created based on the failure of the CAA. AB32 holds the system owner accountable for refrigerants in their control. Without enforcement, there is no motivating reason for anyone to adhere to regulations. [0076]
EPA Response: See previous response in this section to Rapid Recovery Franchise Partners.
> Golden Refrigerant is concerned about where additional HCFC-22 that will be reclaimed will come from. The commenter believes additional HCFC-22 will come from increased compliance and increased retrofits. They believe that the majority of non-compliance comes from smaller heating and cooling contractors, smaller demolition contractors, and individuals because their prices are too low for legitimate contractors to match and they do not want to pay the cost or take the time to correctly recover the refrigerant. They suggest that EPA dramatically increases enforcement, or it is doubtful that there will be a dramatic increase in the returned refrigerant from this source. [0054]
EPA Response: See previous response in this section to Rapid Recovery Franchise Partners.


[Federal Register Volume 78, Number 14 (Tuesday, January 22, 2013)]
[Notices]
[Page 4481]
[FR Doc No: 2013-01270]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

FEDERAL REGISTER CITATION OF PREVIOUS ANNOUNCEMENT: [78 FR 3923,
January 17, 2013].

STATUS: Closed Meeting.

PLACE: 100 F Street NW., Washington, DC.

DATE AND TIME OF PREVIOUSLY ANNOUNCED MEETING: January 17, 2013.

CHANGE IN THE MEETING: Deletion of Item.
    The following item will not be considered during the Closed Meeting
on Thursday, January 17, 2013: Consideration of amicus participation.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items. For further information and to
ascertain what, if any, matters have been added, deleted or postponed,
please contact the Office of the Secretary at<PHONE_NUMBER>.

     Dated: January 17, 2013.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2013-01270 Filed 1-17-13; 4:15 pm]
BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 241 (Monday, December 18, 2017)]
[Notices]
[Pages 60081-60082]
[FR Doc No: 2017-27147]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-82300; File No. SR-CboeEDGX-2017-004]

Self-Regulatory Organizations; Cboe EDGX Exchange, Inc.; Notice
of Filing and Immediate Effectiveness of a Proposed Rule Change Related
to Fees for Use on the Cboe EDGX Exchange, Inc. Equity Option Platform

December 12, 2017.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on December 1, 2017, Cboe EDGX Exchange, Inc. (the ``Exchange'' or
``EDGX'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. The
Exchange has designated the proposed rule change as one establishing or
changing a member due, fee, or other charge imposed by the Exchange
under Section 19(b)(3)(A)(ii) of the Act \3\ and Rule 19b-4(f)(2)
thereunder,\4\ which renders the proposed rule change effective upon
filing with the Commission. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange filed a proposal to amend the fee schedule applicable
to Members \5\ and non-Members of the Exchange pursuant to EDGX Rules
15.1(a) and (c).
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    \5\ The term ``Member'' is defined as ``any registered broker or
dealer that has been admitted to membership in the Exchange.'' See
Exchange Rule 1.5(n).
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    The text of the proposed rule change is available at the Exchange's
website at www.markets.cboe.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
Sections A, B, and C below, of the most significant parts of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to modify the Fee Schedule applicable to the
Exchange's equity options platform (``EDGX Options'') to modify the
description of certain pricing applicable to complex orders on EDGX
Options.
    The Exchange recently began accepting complex orders in connection
with the launch of the EDGX Options complex order book (``COB'').\6\ In
turn, the Exchange adopted base fees and rebates applicable to complex
orders to accommodate the acceptance of complex orders,\7\ and then
adopted various tiers to incentivize the entry of complex orders to the
Exchange.\8\ In connection with such pricing, the Exchange adopted
certain pricing applicable to Non-Customer \9\ orders which trade
against Non-Customers that is variable depending on whether an order
adds or removes liquidity. In particular, fee codes ZF, ZG, ZH and ZJ
are assigned depending on whether an order added (ZF and ZH) or removed
(ZG and ZJ) liquidity.
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    \6\ See Securities Exchange Act Release No. 81891 (October 17,
2017) (SR-BatsEDGX-2017-29) (order approving rules for EDGX complex
order book).
    \7\ The Exchange initially filed to adopt complex order pricing
on October 23, 2017 (SR-BatsEDGX-2017-42). On October 31, 2017 the
Exchange withdrew SR-BatsEDGX-2017-42 and submitted a filing to
replace such filing (SR-BatsEDGX-2017-48).
    \8\ The Exchange initially filed to adopt tiers for its complex
order pricing on November 1, 2017 (SR-BatsEDGX-2017-49). On November
8, 2017 the Exchange withdrew SR-BatsEDGX-2017-49 and submitted a
filing to replace such filing (SR-BatsEDGX-2017-50).
    \9\ ``Non-Customer'' applies to any transaction that is not a
Customer order. See the Exchange's fee schedule available at http://markets.cboe.com/us/options/membership/fee_schedule/edgx.
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    The Exchange proposes to add additional language to footnote 8 of
the fee schedule to make clear when it considers an order to have added
or removed liquidity when an order is executed in a Complex Order
Auction. Specifically, as proposed, footnote 8 would state the
following:
     For an execution that occurs within a Complex Order
Auction (``COA'') against an unrelated order received after the COA was
initiated or a COA response, for the purpose of assigning fee codes the
initiating order is considered the adder and the unrelated order or COA
response is considered the remover.
     For an execution that occurs within a COA against an
unrelated order that was resting on the Exchange's order book when the
COA was initiated, for the purpose of assigning fee codes the
initiating order is considered the remover and the unrelated order is
considered the adder.
    The Exchange proposes this method of assigning add and remove to
provide the status of adder to the order that should be considered
``first'' as between an order that initiates a COA or an unrelated
order posted to the Exchange's order book. There are no cases in which
an order that responds to a COA would be considered the adder of
liquidity as, by definition, a response to a COA is always received
after a COA has been initiated. The Exchange is not proposing to modify
any of the rates applicable to complex orders processed by the
Exchange.
Implementation Date
    The Exchange proposes to implement the proposed changes
immediately.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder that are applicable to a national securities exchange, and,
in particular, with the requirements of Section 6 of the Act.\10\
Specifically, the Exchange believes that the proposed rule change is
consistent with Section 6(b)(4) of the Act,\11\ in that it provides for
the equitable allocation of reasonable dues, fees and other charges
among Members and other persons using any facility or system which the
Exchange operates or controls.
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    \10\ 15 U.S.C. 78f.
    \11\ 15 U.S.C. 78f(b)(4).
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    In particular, the Exchange believes that the proposed fee change
is reasonable and equitably allocated as it will make clear in the
context of the COA process the orders that will be assigned fee codes
for orders that add liquidity and those that will be assigned fee codes
for orders that remove liquidity. The Exchange further believes that
the process of assigning status as adder to the order that was first
between an order that initiates a COA or an order posted to the
Exchange's order book is a reasonable implementation that is analogous
to how such status is applied by the Exchange with respect to trading
on the Exchange generally. The Exchange further believes the proposal

is not unreasonably discriminatory because the process for assigning
add and remove values is equally applied to all Members.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange believes the proposed amendment to its fee schedule
would not impose any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act. The Exchange
does not believe that the proposed change to add language to the
Exchange's fee schedule burdens competition, but instead, improves the
transparency and clarity of the Exchange's fee schedule. Further, the
Exchange does not believe that the assignment of status as adder or
remover burdens competition as between Members that submit orders to
the Exchange that post to the Exchange's order book and Members that
submit orders that initiate COAs because the process of assigning adder
and remover status is clearly delineated in the fee schedule and is
reasonable for the reasons described above.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any written comments from members or other interested parties.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \12\ and paragraph (f) of Rule 19b-4
thereunder.\13\ At any time within 60 days of the filing of the
proposed rule change, the Commission summarily may temporarily suspend
such rule change if it appears to the Commission that such action is
necessary or appropriate in the public interest, for the protection of
investors, or otherwise in furtherance of the purposes of the Act.
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    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 240.19b-4(f).
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IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-CboeEDGX-2017-004 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
All submissions should refer to File Number SR-CboeEDGX-2017-004. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of such filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-CboeEDGX-2017-004, and should be
submitted on or before January 8, 2018.
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    \14\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2017-27147 Filed 12-15-17; 8:45 am]
 BILLING CODE 8011-01-P