PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request EPA, OSWER, Office of Brownfields Cleanup and Redevelopment 2. OMB control number b. G None a. 2 0 5 0  0192 __ __ __ __ __

3. Type of information collection ( check one) a. G New collection b. X Revision of a currently approved collection c. G Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No For b f, note item A2 of Supporting Statement Instructions " Small Business Liability Relief and Brownfields Revitalization Act" ( Public Law 107 118, January 2002) 6. Requested expiration date a. X Three years from approval date b. G Other Specify: / /___

7. Title Brownfields Program   Revitalization Grantee Reporting 8. Agency form number( s) ( If applicable) EPA ICR No. 2104.01 9. Keywords Brownfields; grants; proposals; property profile; job training performance measures.

10. Abstract This ICR addresses the burden imposed upon grant recipients for reporting and record keeping requirements under Subtitle A and Subtitle C of the Small Business Liability Relief and Brownfields Revitalization Act ( Public Law 107 118).

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. Business or other for profit e. Federal Government c. X Not for profit institutions f. P State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. X Required to obtain or retain benefits c. G Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 294 b. Total annual responses 6,101 1. Percentage of these responses collected electronically 30 % c. Total hours requested 8,683 d. Current OMB inventory 7,320 e. Difference 1,363 f. Explanation of difference 1. Program Change Inclusion of Subtitle C Grant Recipients 2. Adjustment ________________________________ 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs 0 b. Total annual costs ( O& M) $ 260,648 c. Total annualized cost requested $ 260,648 d. Current OMB inventory $ 216,393 e. Difference $ 44,255 f. Explanation of difference 1. Program change Inclusion of Subtitle C Grant Recipients 2. Adjustment _____________________________________

15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. P Application for benefits e. X Program planning or management b. X Program evaluation f. Research c. General purpose statistics g. Regulatory or compliance d. __ Audit 16. Frequency of record keeping or reporting ( check all that apply) a. Record keeping b. Q Third party disclosure c. X Reporting 1. On occasion 2. Q Weekly 3. Q Monthly 4. X Quarterly 5. Q Semi annually 6. Q Annually 7. X Biannually 8. Q Other ( describe)

17. Statistical methods Does this information collection employ statistical methods?

Q Yes X No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Jennifer Wilbur Phone: 202 566 2756 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3):

( i) Why the information is being collected; ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( i) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Official Linda Garczynski, Director Office of Brownfields Cleanup and Redevelopment Office of Solid Waste and Emergency Response Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information Date OMB 83 I 10/ 95 Certification Requirement for Paperwork Reduction Act Submissions 5 CFR 1320.9 reads " As part of the agency submission to OMB of a proposed collection of information, the agency ( through the head of the agency, the Senior Official or their designee) shall certify ( and provide a record supporting such certification) that the proposed collection of information

"( a) is necessary for the proper performance of the functions of the agency, including that the information to be collected will have practical utility;

"( b) is not unnecessarily duplicative of information otherwise reasonably accessible to the agency;

"( c) reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the agency, including with respect to small entities, as defined in the Regulatory Flexibility Act 5 U. S. C. § 601( 6)), the use of such techniques as:

"( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; "( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof;

"( d) is written using plain, coherent, and unambiguous terminology and is understandable to those who are to respond;

"( e) is to be implemented in ways consistent and compatible, to the maximum extent practicable, with the existing reporting and record keeping practices of those who are to respond;

"( f) indicates for each record keeping requirement the length of time persons are required to maintain the records specified;

"( g) informs potential respondents of the information called for under § 1320.8( b)( 3); [ see below]

"( h) has been developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner which shall enhance, where appropriate, the utility of the information to agencies and the public;

"( i) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public."

NOTE: 5 CFR 1320.8( b)( 3) requires that each collection of information:

"( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of:

"( i) the reasons the information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection ( together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit ( citing authority), or mandatory ( citing authority); "( v) the nature and extent of confidentiality to be provided, if any ( citing authority); and "( vi) the fact that any agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number."

OMB 83 I ( Instructions) 10/ 95


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Section D:
MODEL QUALIFIED HEALTH CLAIM
Proposed Language
We propose the following qualified health claim language for use on the labels or in
labeling for 100% whey-protein partially hydrolyzed infant formulas:
Breastfeeding is the best way to nourish infants.  For infants who are not
exclusively breastfed, emerging clinical research shows that, in healthy
infants with family history of allergy, feeding a 100% Whey-Protein Partially
Hydrolyzed infant formula instead of a formula containing intact cow’s milk
proteins may reduce the risk of developing the most common allergic disease
of infancy – atopic dermatitis – throughout the 1st year of life and up to 3
years of age.
Partially hydrolyzed formulas are not intended to treat existing food allergy
symptoms. If you suspect your baby is already allergic to milk, or if your
baby is on a special formula for the treatment of allergy, your baby's care
and feeding choices should be under a doctor’s supervision.
Consistent with FDA’s health claim regulations, this model claim is justified by the
summary of scientific data discussed in Section B of this Petition.  Obviously, any claim in this
area must be carefully worded so that it not only accurately reflects the current state of scientific
knowledge but also serves as an intelligible and useful message to parents and caregivers.
The first sentence of the claim reminds the reader that breastfeeding is the preferred
method of feeding an infant.  Nothing in this claim is designed or operates to dissuade mothers
from nursing their infants.  The remainder of the first paragraph focuses on infants who are not
exclusively breastfed, and describes both the substance/disease relationship and the level of
science in support of this relationship.

2
The second paragraph is crafted to help ensure against any potential for confusion as to
whether a PHF-W formula should be used for treatment of atopic dermatitis or other allergies/
allergic manifestations.   The language clearly and unequivocally instructs the consumer not to
use the product in infants with diagnosed cow’s milk or other related allergy.  The ingredient list
will continue to function as an additional source of clarification as to the proper use of PHF-W,
by clearly providing that the main ingredient is derived from cow’s milk.  This method of
ingredient listing accords with longstanding Nestlé practice and is in compliance with the
requirements of the Food Allergen Labeling and Consumer Protection Act.
Validation of the Proposed Language by Relevant Experts
We asked a leading expert in the field of pediatric immunology (Hugh Sampson, MD –
Chief, Pediatric Allergy and Immunology Division, Director of the Jaffe Food Allergy Institute,
Mount Sinai School of Medicine, New York) and a well-known lay communicator on the topic
of pediatric allergic disease (Anne Muñoz-Furlong of the Food Allergy & Anaphylaxis Network
(FAAN)) to review this language – each from the point of view of his or her particular expertise.
Specifically, we asked Ms. Muñoz-Furlong for her views on whether the language would
accurately convey to interested consumers the message that a partially hydrolyzed whey formula
is not for use with an “established milk allergic child” but may, when compared with intact
cow’s milk formulas, reduce the risk of atopic dermatitis in healthy infants considered to be at
“high risk” for developing allergy based on family history.  We asked Dr. Sampson whether the
language would accurately convey the level of scientific evidence that supports that use.  Ms.
Muñoz-Furlong’s and Dr. Sampson’s letters in response to our request for review are attached at
the end of this Section.

3
Qualified vs. Unqualified Health Claim
We have been urged by many in the pediatric medical community to propose a claim that
does not contain the qualifier “emerging science”.  Admittedly, we believe the supporting
evidence for the claimed relationship between PHF-W and a reduced risk of atopic dermatitis
comes very close to establishing a basis for the Significant Scientific Agreement standard
required of an unqualified health claim.  Nestlé recognizes, however, the evolutionary character
of allergy-related investigation and the time dependent nature of scientific consensus, as well as
the novelty and importance of a health claim associated with infant formula.  Under these
circumstances, and consistent with the general and understandable conservatism of the pediatric
community, we request agency review for the highest possible level of qualified health claim and
waive review under the Significant Scientific Agreement standard.
Qualified Health Claim vs. Food Avoidance Claim
In the Letter of Denial of our 2005 Qualified Health Claim, the agency suggested the
need for a control group comprising infants fed formula containing intact whey protein and no
casein – reasoning that “eliminating one of the major allergens (casein) from a formula could
reduce the incidence of food allergy when compared to the cow’s milk formula that contains
casein, notwithstanding any potential effect of the partial hydrolysis of whey protein on food
allergy risk” (Letter of Denial, page 7).  One possible reading of this criticism is that the agency
was concerned that, absent any evidence suggesting that partially hydrolyzed whey protein itself
had an effect on reducing allergy, the claim was simply a “food avoidance” claim and not worthy
of qualified health claim status.  We trust that such a reading was not intended by the agency
because the statute does not focus on the effect of a substance on a disease but rather on the

4
“relationship” between a substance and a disease.  In any event, a number of the authorized
“significant scientific agreement” health claims, as well as qualified health claims, can
reasonably be characterized as food avoidance claims (see, e.g., non-cariogenic carbohydrate
sweeteners and dental carries (21 CFR 101.80); fresh fruits and vegetables and cancer (21 CFR
101.78); dietary lipids and cancer (21 CFR 101.73); etc.).  In some cases, the “substance” itself
has been shown to have an effect, while in others an effect has merely been suggested.  100%
whey-protein partially hydrolyzed infant formulas (PHF-W) fall into the latter group.  To that
end, there are a number of possible mechanisms for the role of PHF-W in reducing the risk of
atopic dermatitis.  One possible mechanism, for example, involves what has been referred to as
“oral tolerance”.  For more detail on this and other possible mechanisms of effect, please see the
discussion of “Preclinical Indicators of Functionality” in Section C, above.
Benefit to Public Health
Because of the increasing incidence of allergic disease in recent decades, particularly in
developed countries such as the United States, dissemination to the general public of the
information in the proposed claim may help alleviate some of the public health burden of allergic
manifestations.  Breastfeeding, of course, is widely recognized as the optimal way to feed an
infant – particularly one with a family history of allergy – and the proposed claim is carefully
worded to encourage breastfeeding.  According to the most recent CDC report on this topic, the
percentage of infants who are initiated to breastfeeding in the U.S. has increased over the last
few years to 77%, exceeding the goal of 75% set for Healthy People 2010 (McDowell MA
2008).  However, that figure does not reflect the fact that having initiated breastfeeding is not
necessarily equivalent to breastfeeding exclusively; nor is it equivalent to breastfeeding
throughout the entire first year of life, as recommended by the AAP.   In fact, according to a

5
recently published analysis of data from FDA’s Infant Feeding Practices Study II (IFPS II was
carried out from 2005 – 2007), 61% of infants were receiving all or part of their nutrition from
infant formula by the age of 3 months, and the percentage of formula-fed, or partially formula-
fed infants continued to increase throughout the first year of life (Grummer-Strawn LM 2008).
Given this broad exposure of the U.S. infant population to infant formula, as well as the potential
health significance attached to the choice of which type of infant formula to feed, Nestlé believes
that this qualified health claim is in the public interest, that it will provide meaningful,
scientifically sound and truly helpful information to caregivers and physicians, and that it will
foster scientific interest and further research in this important arena.
We recognize that our proposed claim is novel in some respects, when compared with
previously authorized claims.  All authorized health claims provide information helpful to a
consumer’s ability to choose wisely among an array of food and dietary options.  With respect to
infant formulas for infants who are not exclusively breastfed, however, the dietary choice is
extremely limited.  For general purposes, the choice of a first formula devolves to a decision
between two basic formula types, both marketed for routine use as a sole source of nutrition or as
a supplement to breastfeeding.  On the one hand are formulas based on 100% whey-protein
partially hydrolyzed – and on the other hand, are formulas that rely on a blend of intact cow’s-
milk proteins (whey and casein).  In this context, the proposed claim, perhaps more than any
previously authorized health claim, provides any interested parents and caregivers (of infants
who are not exclusively breastfed) the opportunity to easily and efficiently make and commit to a
specific dietary choice.  For healthy infants whose family history identifies them as being at
particular risk for developing allergy – this choice is a relevant one, as it carries the potential to

6
reduce the risk of the most common allergic disease in infants. It is difficult to imagine a claim
more consistent with the purposes and goals of the 1990 Nutrition Labeling and Education Act.

May 6, 2009
Jose M. Saavedra, M.D.
Medical and Scientific Director
Nestle Nutrition Division
Nestle USA
Dear Dr. Saavedra,
I have reviewed the following statement, which you are proposing to use as a health claim for
Nestlé’s partially hydrolyzed whey formula:
Breastfeeding is the best way to nourish infants. For infants who are not exclusively breastfed,
emerging clinical research shows that, in healthy infants with family history of allergy, feeding a
100% Whey-Protein Partially Hydrolyzed infant formula instead of a formula containing intact cow’s
milk proteins may reduce the risk of the most common allergic disease of infancy
–
atopic dermatitis
–
throughout the 1st year of life and up to 3 years of age.
Partially hydrolyzed formulas are not intended to treat existing food allergy symptoms. If you suspect
your baby is already allergic to milk, or if your baby is on a special formula for the treatment of
allergy, your baby's care should be under a doctor’s supervision.
I believe that this statement is scientifically consistent with the results of the 6 years follow-up data
from the GINI study, which is the largest independent study of hydrolyzed infant formulas. [von Berg
A, et al. Preventive effect of hydrolyzed infant formulas persists until age 6 years: long-term results from the
German Infant Nutritional Intervention Study (GINI). J Allergy Clin Immunol 2008; 121(6):1442-1447]. I
believe that it is also consistent with the 2007 Cochrane report on hydrolyzed formulas containing
cow’s milk proteins.
I think that the statement clearly conveys the level of knowledge in this area and adequately stresses
the safety concerns of feeding a partially hydrolyzed formula to an established milk allergic child.
Sincerely,

Hugh A. Sampson, M.D.
Kurt Hirschhorn Professor of Pediatrics and Immunology
Director, Jaffe Food Allergy Institute

Department of Pediatrics
Division of Allergy & Immunology
Hugh A. Sampson, MD
Scott H. Sicherer, MD
Anna Nowak-Wegrzyn, MD
Wayne G. Shreffler, MD, PhD
Julie Wang, MD
Kirsi M. Jarvinen, MD, PhD
Justin M. Skripak, MD
Amanda L. Cox, MD
One Gustave L. Levy Place
Box 1198
New York, NY 10029-6574
Tel:<PHONE_NUMBER>
Fax:<PHONE_NUMBER>


(iv) The draining and flushing shall be done more frequently if an
occupant reports a taste or health problem associated with the water,
or following any plumbing repair.
    (5) Reported problems. Following any report of a taste problem with
the water from a system or a health problem resulting from the water in
a system, samples of water from each tap or dispensing location on the
system shall be collected and sent to a laboratory approved by the U.S.
Environmental Protection Agency for testing for heterotrophic plate
counts, total coliform, and fecal coliform. If a single sample fails
any of these tests, the system must be treated as follows:
    (i) Heterotrophic plate count. Drain and flush the system within
two days, and then return it to service.
    (ii) Total coliform. Remove the system from service, drain and
flush system, resample the system, and then return the system to
service.
    (iii) Fecal coliform. Remove the system from service, drain and
flush the system, resample the system, and do not return the system to
service until a satisfactory result on the test of the samples is
obtained from the laboratory.
    (6) Reports. All laboratory reports pertaining to the water system
of the camp car shall be maintained with the car. Within 15 days of the
receipt of such a laboratory report, a copy of the report shall be
posted for a minimum of 10 calendar days at a conspicuous location
within the camp car or cars affected for review by occupants. The
report shall be maintained in the camp for the duration of the same
connection. When the connection is terminated, the certification must
be submitted promptly to a centralized location for the railroad and
maintained for one year from the date the connection was terminated.
    (d) Signage. Any water outlet/faucet within the camp car facility
that supplies water not from a potable source or that is from a potable
source but supplied through a system that is not maintained as required
in this section, the outlet/faucet must be labeled with a sign, visible
to the user and bearing a message to the following effect: ``The water
is not suitable for human consumption. Do not drink the water.''

Sec.  228.325  Food service in a camp car or separate kitchen or dining
facility in a camp.

    (a) Sanitary storage. No food or beverage may be stored in a toilet
room or in an area exposed to a toxic material.
    (b) Consumption of food or beverage on the premises. No occupant
shall be allowed to consume a food or beverage in a toilet room or in
any area exposed to a toxic material.
    (c) Kitchens, dining halls, and feeding facilities. (1) In each
camp car where central dining operations are provided by the railroad
or its contractor(s) or subcontractor(s), the food handling facilities
shall be maintained in a clean and sanitary condition. See Sec.
228.323, Potable water, generally.
    (i) All surfaces used for food preparation shall be disinfected
after each use.
    (ii) The disinfection process shall include removal of chemical
disinfectants that would adulterate foods prepared subsequent to
disinfection.
    (2) All perishable food shall be stored either under refrigeration
or in a freezer. Refrigeration and freezer facilities shall be provided
with a means to monitor temperature to ensure proper temperatures are
maintained. The temperature of refrigerators shall be maintained at
40[emsp14][deg]F or below; the temperature of freezers shall be
maintained at 0[emsp14][deg]F or below at all times.
    (3) All non-perishable food shall be stored to prevent vermin and
insect infestation.
    (4) All food waste disposal containers shall be constructed to
prevent vermin and insect infestation.
    (i) All food waste disposal containers used within a camp car shall
be emptied after each meal, or at least every four hours, whichever
period is less.
    (ii) All food waste disposal containers used outside a camp car
shall be located to prevent offensive odors from entering the sleeping
quarters.
    (iii) All kitchen area camp car sinks used for food washing and
preparation and all kitchen area floor drains shall be connected to a
public sewer where available and practicable, unless the car is
equipped with a holding tank that is emptied in a sanitary manner. For
kitchen area sinks and floor drains identified in this paragraph
(c)(4)(iii) connected to a holding tank, the tank must be constructed
in a manner that prevents vermin from entry into the tank or odors from
escaping into any camp car.
    (iv) The sewage disposal method must not endanger the health of
occupants.
    (5) When a separate kitchen or dining hall car is provided, there
must be a closeable door between the living or sleeping quarters into a
kitchen or dining hall car.
    (d) Food handling. (1) All food service facilities and operations
for occupants of a camp car by the railroad or its contractor(s) or
subcontractor(s) shall be carried out in accordance with sound hygienic
principles. In all places of employment where all or part of the food
service is provided, the food dispensed must be wholesome, free from
spoilage, and must be processed, prepared, handled, and stored in such
a manner as to be protected against contamination. See Sec.  228.323,
Potable water, generally.
    (2) No person with any disease communicable through contact with
food or a food preparation item may be employed or permitted to work in
the preparation, cooking, serving, or other handling of food,
foodstuffs, or a material used therein, in a kitchen or dining facility
operated in or in connection with a camp car.
    (e) The limitations of paragraphs (c) and (d) of this section do
not apply to food service from restaurants near the camp car consist
that are subject to State law.

Sec.  228.327  Waste collection and disposal.

    (a) General disposal requirements. All sweepings, solid or liquid
wastes, refuse, and garbage in a camp must be removed in such a manner
as to avoid creating a menace to health and as often as necessary or
appropriate to maintain a sanitary condition.
    (b) General waste receptacles. Any exterior receptacle used for
putrescible solid or liquid waste or refuse in a camp shall be so
constructed that it does not leak and may be thoroughly cleaned and
maintained in a sanitary condition. Such a receptacle must be equipped
with a solid tight-fitting cover, unless it can be maintained in a
sanitary condition without a cover. This requirement does not prohibit
the use of receptacles designed to permit the maintenance of a sanitary
condition without regard to the aforementioned requirements.
    (c) Food waste disposal containers provided for the interior of
camp cars. An adequate number of receptacles constructed of smooth,
corrosion resistant, easily cleanable, or disposable materials, must be
provided and used for the disposal of waste food. Receptacles must be
provided with a solid, tight-fitting cover unless sanitary conditions
can be maintained without use of a cover. The number, size, and
location of such receptacles must

encourage their use and not result in overfilling. They must be emptied
regularly and maintained in a clean, safe, and sanitary condition.

Sec.  228.329  Housekeeping.

    (a) A camp car must be kept clean to the extent allowed by the
nature of the work performed by the occupants of the camp car.
    (b) To facilitate cleaning, every floor, working place, and
passageway must be kept free from protruding nails, splinters, loose
boards, and unnecessary holes and openings.

Sec.  228.331  First aid and life safety.

    (a) An adequate first aid kit must be maintained and made available
for occupants of a camp car for the emergency treatment of an injured
person.
    (b) The contents of the first aid kit shall be placed in a
weatherproof container with individual sealed packages for each type of
item, and shall be checked at least weekly when the camp car is
occupied to ensure that the expended items are replaced. The first aid
kit shall contain, at a minimum, the following:
    (1) Two small gauze pads (at least 4 x 4 inches);
    (2) Two large gauze pads (at least 8 x 10 inches);
    (3) Two adhesive bandages;
    (4) Two triangular bandages;
    (5) One package of gauge roller bandage that is at least 2 inches
wide;
    (6) Wound cleaning agent, such as sealed moistened towelettes;
    (7) One pair of scissors;
    (8) One set of tweezers;
    (9) One roll of adhesive tape;
    (10) Two pairs of latex gloves; and
    (11) One resuscitation mask.
    (c) Each sleeping room shall be equipped with the following:
    (1) A functional portable Type ABC fire extinguisher; and
    (2) Either a functional smoke alarm and a carbon monoxide alarm, or
a functional combined smoke-carbon-monoxide alarm.
    (d) Each camp car consist shall have an emergency preparedness plan
prominently displayed so all occupants of the camp car consist can view
it at their convenience. The plan shall address the following subjects
for each location where the camp car consist is used to house railroad
employees or MOW workers:
    (1) The means used to be aware of and notify all occupants of
impending weather threats, including thunderstorms, tornados,
hurricanes, floods, and other major weather-related risks;
    (2) Shelter-in-place and emergency and evacuation instructions for
each of the specific threats identified; and
    (3) The address and telephone number of the nearest emergency
medical facility and directions on how to get there from the camp car
consist.

Sec.  228.333  Remedial action.

    A railroad shall, within 24 hours after receiving a good faith
notice from a camp car occupant or an employee labor organization
representing camp car occupants or notice from a Federal Railroad
Administration inspector, including a certified State inspector under
part 212 of this chapter, of noncompliance with this subpart, correct
each non-complying condition on the camp car or cease use of the camp
car as sleeping quarters for each occupant. In the event that such a
condition affects the safety or health of an occupant, such as, but not
limited to, water, cooling, heating, or eating facilities, sanitation
issues related to food storage, food handling or sewage disposal,
vermin or pest infestation, or electrical hazards, the railroad must
immediately upon notice provide alternative arrangements for housing
and providing food to the employee or MOW worker until the condition
adverse to the safety or health of the occupant(s) is corrected.

Sec.  228.335  Electronic recordkeeping.

    (a) Each railroad shall keep records as required by Sec.  228.323
either--
    (1) On paper forms provided by the railroad, or
    (2) By electronic means that conform with the requirements of
subpart D of this part.
    (b) Records required to be kept shall be made available to the
Federal Railroad Administration as provided by 49 U.S.C. 20107.

Appendix A to Part 228  [Amended]

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14. The last paragraph of the discussion headed ``Sleeping Quarters''
in Appendix A to part 228 is removed.

Appendix C to Part 228  [Removed and Reserved]

0
15. Appendix C to part 228 is removed and reserved.

    Issued in Washington, DC, on October 24, 2011.
 Joseph C. Szabo,
Administrator.
[FR Doc. 2011-27818 Filed 10-28-11; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 76, Number 200 (Monday, October 17, 2011)]
[Proposed Rules]
[Pages 64059-64065]
[FR Doc No: 2011-26768]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 51

[EPA-HQ-OAR-2010-0605; FRL-9480-4]
RIN 2060-AQ38

Air Quality: Revision to Definition of Volatile Organic
Compounds--Exclusion of trans-1,3,3,3-tetrafluoropropene and 2,3,3,3-
tetrafluoropropene

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The EPA is proposing to revise the agency's definition of
volatile organic compounds (VOCs) for purposes of preparing state
implementation plans (SIPs) to attain the national ambient air quality
standards (NAAQS) for ozone under Title I of the Clean Air Act (CAA).
This proposed revision would add 2,3,3,3-tetrafluoropropene (also known
as HFO-1234yf) and trans-1,3,3,3-tetrafluoropropene (also known as HFO-
1234ze) to the list of compounds excluded from the definition of VOC on
the basis that these compounds make a negligible contribution to
tropospheric ozone formation.

DATES: Comments must be received on or before November 16, 2011.
    Public Hearing: If anyone contacts us requesting to speak at a
public hearing on or before November 1, 2011, we will hold a public
hearing. Additional information about the hearing would be published in
a subsequent Federal Register notice.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2010-0605, by one of the following methods:
     http://www.regulations.gov. Follow the on-line
instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>Attention Docket
ID No. EPA-HQ-OAR-2010-0605.
     Fax:<PHONE_NUMBER>, Attention Docket ID No. EPA-HQ-OAR-
2010-0605.
     Mail: Docket ID No. EPA-HQ-OAR-2010-0605, Environmental
Protection Agency, Mailcode: 6102T, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460.
     Hand Delivery: EPA Docket Center, U.S. Environmental
Protection Agency, 1301 Constitution Avenue, NW., Room: 3334, Mail
Code: 6102T, Washington, DC 20460, Attention Docket ID No. EPA-HQ-OAR-
2010-0605. Such deliveries are only accepted during the Docket's normal
hours of operation, and special arrangements should be made for
deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2010-0605. The EPA's policy is that all comments received will be
included in the public docket without change and may be made available
online at http://www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through http://www.regulations.gov, or e-mail. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means the EPA will not know
your identity or contact information unless you provide it in the body
of your comment. If you send an e-mail comment directly to the EPA
without going through http://www.regulations.gov, your e-mail address
will be automatically captured and included as part of the comment that
is placed in the public docket and made available on the Internet. If
you submit an electronic comment, the EPA recommends that you include
your name and other contact information in the body of your comment and
with any disk or CD-ROM you submit. If the EPA cannot read your comment
due to technical difficulties and cannot contact you for clarification,
the EPA may not be able to consider your comment. Electronic files
should avoid the use of special characters, any form of encryption, and
be free of any defects or viruses. For additional information about the
EPA's public docket, visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the EPA, EPA/DC, EPA
West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the EPA
Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: David Sanders, Office of Air Quality
Planning and Standards, Air Quality Policy Division, Mail Code C539-01,
Research Triangle Park, NC 27711; telephone:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    Entities potentially affected by this proposed rule include, but
are not necessarily limited to, states (typically state air pollution
control agencies) that control VOCs, and industries involved in the
manufacture or use of refrigerants, aerosol propellants, and blowing
agents for insulating foams.

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           Industry group                           SIC \a\                               NAICS \b\
----------------------------------------------------------------------------------------------------------------
Refrigerants.......................  2869, 3585...........................  238220, 336111, 336391.
Aerosol propellants................  2869.................................  325998.
Blowing agents.....................  2869, 3086...........................  326140, 326150.
----------------------------------------------------------------------------------------------------------------
\a\ Standard Industrial Classification.
\b\ North American Industry Classification System.

    This proposed rule is applicable to all manufacturers,
distributors, and users of these chemical compounds. The use of these
compounds is subject to restrictions under the CAA and the Toxic
Substances Control Act (TSCA). Specifically, the use of these compounds
as aerosol propellants, blowing agents, or refrigerants, or any other
use in which they would substitute for chlorofluorocarbons,
hydrochlorofluorocarbons, or their

substitutes, is subject to restrictions under the Significant New
Alternatives Policy (SNAP) program (CAA Sec.  612; 40 CFR 82 subpart
G). The SNAP program has issued a final approval for HFO-1234yf as a
substitute for use in the motor vehicle air conditioning end-use as a
replacement for ozone depleting substances (76 FR 17488, March 29,
2011), and final approvals for HFO-1234ze as a suitable foam and
refrigerant substitute and as a propellant (74 FR 50129, September 30,
2009; 75 FR 34017, June 16, 2010). Furthermore, HFO-1234yf is subject
to a Significant New Use Rule (SNUR) under TSCA. (75 FR 65987, October
27, 2010). The implications of these other regulations are discussed in
more detail in Section III.

B. What should I consider as I prepare my comments for the EPA?

    Submitting CBI: Do not submit this information to the EPA through
http://www.regulations.gov or e-mail. Clearly mark the part or all of
the information that you claim to be CBI. For CBI information in a disk
or CD-ROM that you mail to the EPA, mark the outside of the disk or CD-
ROM as CBI and then identify electronically within the disk or CD-ROM
the specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.

C. How can I find information about a possible public hearing?

    Public Hearing: To request a public hearing or information
pertaining to a public hearing on this document, contact Ms. Pamela S.
Long, Air Quality Policy Division, Mail code C504-01, U.S.
Environmental Protection Agency, Research Triangle Park, NC 27711,
telephone<PHONE_NUMBER>, facsimile number<PHONE_NUMBER>, e-mail
address<EMAIL_ADDRESS>
D. How is this preamble organized?

    The information presented in this preamble is organized as follows:

I. General Information
    A. Does this action apply to me?
    B. What should I consider as I prepare my comments for the EPA?
    C. How can I find information about a possible public hearing?
    D. How is this preamble organized?
II. Background
    A. Petition To List HFO-1234yf
    B. Petition To list HFO-1234ze
III. The EPA's Proposed Responses to the Petitions
    A. Contribution to Tropospheric Ozone
    B. Likelihood of Risk to Human Health or the Environment
    C. Conclusions
IV. Proposed Action
V. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Executive
Order 13563: Improving Regulation and Regulatory Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From
Environmental Health and Safety Risks
    H. Executive Order 13211: Actions That Significantly Affect
Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act
    J. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations.

II. Background

    Tropospheric ozone, commonly known as smog, is formed when VOCs and
nitrogen oxides (NOX) react in the atmosphere in the
presence of sunlight. Because of the harmful health effects of ozone,
the EPA and state governments limit the amount of VOCs that can be
released into the atmosphere. The VOCs are those organic compounds of
carbon which form ozone through atmospheric photochemical reactions.
Different VOCs have different levels of reactivity--that is, they do
not react to form ozone at the same speed or do not form ozone to the
same extent. Some VOCs react slowly, or form less ozone; therefore,
changes in their emissions have limited effects on local or regional
ozone pollution episodes. It has been the EPA's policy that organic
compounds with a negligible level of reactivity should be excluded from
the regulatory definition of VOC so as to focus VOC control efforts on
compounds that do significantly increase ozone concentrations. The EPA
also believes that exempting such compounds creates an incentive for
industry to use negligibly reactive compounds in place of more highly
reactive compounds that are regulated as VOCs. The EPA lists these
negligibly reactive compounds in its regulations (at 40 CFR 51.100(s))
and excludes them from the definition of VOC.
    The CAA requires the regulation of VOCs for various purposes.
Section 302(s) of the CAA specifies that the EPA has the authority to
define the meaning of ``VOC,'' and hence what compounds shall be
treated as VOCs for regulatory purposes. The policy of excluding
negligibly reactive compounds from the VOC definition was first laid
out in the ``Recommended Policy on Control of Volatile Organic
Compounds'' (42 FR 35314, July 8, 1977) and was supplemented most
recently with the ``Interim Guidance on Control of Volatile Organic
Compounds in Ozone State Implementation Plans'' (Interim Guidance) (70
FR 54046, September 13, 2005). The EPA uses the reactivity of ethane as
the threshold for determining whether a compound has negligible
reactivity. Compounds that are less reactive than, or equally reactive
to, ethane under certain assumed conditions may be deemed negligibly
reactive and therefore suitable for exemption from the regulatory
definition of VOC. Compounds that are more reactive than ethane
continue to be considered VOCs for regulatory purposes and therefore
subject to control requirements. The selection of ethane as the
threshold compound was based on a series of smog chamber experiments
that underlay the 1977 policy.
    The EPA has used three different metrics to compare the reactivity
of a specific compound to that of ethane: (i) the reaction rate
constant (known as kOH) with the hydroxyl radical (OH); (ii)
the maximum incremental reactivities (MIR) of ethane and the compound
in question expressed on a reactivity per unit mass basis; and (iii)
the MIR of ethane and the compound in question expressed on a
reactivity per mole basis. Differences between these three metrics are
discussed below.
    The kOH is the reaction rate constant of the compound
with the OH radical in the air. This reaction is typically the first
step in a series of chemical reactions by which a compound breaks down
in the air and participates in the ozone-forming process. If this step
is slow, the compound will likely not form ozone at a very fast rate.
The kOH values have long been used by the EPA as a measure
of photochemical reactivity and ozone-forming activity, and they have
been the basis for most of the EPA's previous exemptions of negligibly
reactive compounds from the regulatory definition of VOC. The
kOH metric is inherently a molar comparison, i.e., it
measures the rate at which molecules react.
    The MIR values, both by mole and by mass, are a more recently
developed measure of photochemical reactivity derived from a computer-
based photochemical model. This

measurement considers the complete ozone forming activity of a
compound, not merely the first reaction step. Further explanation of
the MIR metric can be found in: W. P. L. Carter, ``Development of Ozone
Reactivity Scales for Volatile Organic Compositions,'' Journal of the
Air & Waste Management Association, Vol. 44, 881-899, July 1994.
    The MIR values for compounds are typically expressed as grams of
ozone formed per gram of VOC (mass basis), but may also be expressed as
grams of ozone formed per mole of VOC (molar basis). For comparing the
reactivities of two compounds, using the molar MIR values considers an
equal number of molecules of the two compounds. Alternatively, using
the mass MIR values compares an equal mass of the two compounds, which
will involve different numbers of molecules, depending on the relative
molecular weights. The molar MIR comparison is consistent with the
original smog chamber experiments that underlie the original selection
of ethane as the threshold compound and compared equal molar
concentrations of individual VOCs. It is also consistent with previous
reactivity determinations based on inherently molar kOH
values. By contrast, the mass MIR comparison is more consistent with
how MIR values and other reactivity metrics have been applied in
reactivity-based emission limits, such as the national VOC emissions
standards for aerosol coatings (73 FR 15604). Many other VOC
regulations contain limits based upon a weight of VOC per volume of
product, such as the EPA's regulations for limiting VOC emissions from
architectural and industrial maintenance coatings (65 FR 7736).
However, the fact that regulations are structured to measure VOC
content by weight for ease of implementation and enforcement does not
necessarily control whether VOC exemption decisions should be made on a
weight basis as well.
    The choice of the molar basis versus the mass basis for the ethane
comparison can be significant. Given the relatively low molecular
weight of ethane, use of the mass basis tends to result in more VOCs
being classified as ``negligibly reactive'' than in the case of the
molar basis. In some cases, a compound might be considered less
reactive than ethane and eligible for VOC exemption under the mass
basis but not under the molar basis. The compounds considered in this
proposal, HFO-1234yf and HFO-1234ze, fall into this category, where the
molar MIR value is greater than that of ethane, but the mass MIR value
is equal to or less than that of ethane. However, for both compounds,
both MIR values fall in the lower portion of the very wide range of VOC
reactivities.
    The EPA has considered the choice between a molar or mass basis for
the comparison to ethane in past rulemakings and guidance. Most
recently, in the Interim Guidance, the EPA stated:

    [A] comparison to ethane on a mass basis strikes the right
balance between a threshold that is low enough to capture compounds
that significantly affect ozone concentrations and a threshold that
is high enough to exempt some compounds that may usefully substitute
for more highly reactive compounds.
    When reviewing compounds that have been suggested for VOC-exempt
status, EPA will continue to compare them to ethane using
kOH expressed on a molar basis and MIR values expressed
on a mass basis.

    In this action, the EPA is proposing to exempt these compounds
using the comparison to ethane on the mass basis MIR value, because MIR
values are available for these compounds and the EPA believes that this
comparison is appropriate.
    The EPA's 2005 Interim Guidance also notes that concerns have
sometimes been raised about the potential impact of a VOC exemption on
environmental endpoints other than ozone concentrations, including fine
particle formation, air toxics exposures, stratospheric ozone
depletion, and climate change. The EPA has recognized, however, that
there are existing regulatory and non-regulatory programs that are
specifically designed to address these issues, and the agency continues
to believe that the impacts of VOC exemptions on environmental
endpoints other than ozone formation will be adequately addressed by
these programs. The VOC exemption policy is intended to facilitate
attainment of the ozone NAAQS, and questions have been raised as to
whether the agency has authority to use its VOC exemption policy to
address concerns that are unrelated to ground-level ozone. Thus, in
general, VOC exemption decisions will continue to be based solely on
consideration of a compound's contribution to ozone formation. However,
if the agency determines that a particular VOC exemption is likely to
result in a significant increase in the use of a compound and that the
increased use would pose a significant risk to human health or the
environment that would not be addressed adequately by existing programs
or policies, the EPA reserves the right to exercise its judgment in
deciding whether to grant an exemption.
    In this case, the agency has examined available information on the
risks to human health and the environment and applicability of other
regulatory programs; that information for the two compounds considered
here is discussed further in Section III.

A. Petition to List HFO-1234yf

    Honeywell, Inc. submitted a petition to the EPA on June 29, 2009,
requesting that HFO-1234yf (CAS 754-12-1) be exempted from VOC control
based on its low reactivity relative to ethane. The petitioner
indicated that HFO-1234yf may be used as a refrigerant for
refrigeration and air-conditioning. Honeywell also indicated that it
expects HFO-1234yf to be widely used as a replacement for HFC-134a in
motor vehicle air-conditioners (MVAC), and that HFO-1234yf has been
specifically developed for this purpose. Honeywell argues that as a
replacement for use in motor vehicle air conditioners there will be an
environmental advantage in that the global warming potential (GWP) of
HFO-1234yf is 4, which is substantially lower than the GWP for HFC-134a
(100-year GWP = 1430) which HFO-1234yf is designed to replace.
Honeywell submitted several documents, including several peer-reviewed
journal articles, to support this petition that have been added to the
docket for this action.

B. Petition to List HFO-1234ze

    Honeywell, Inc. also submitted a petition to the EPA on December 2,
2009, requesting that HFO-1234ze (CAS 29118-24-9) be exempted from VOC
control based on its low reactivity relative to ethane. The petitioner
indicated that HFO-1234ze may be used in a variety of applications
including as a refrigerant, an aerosol propellant, and a blowing agent
for insulating foam. Honeywell submitted several documents, including
several peer-reviewed journal articles, to support its petition, all of
which have been added to the docket for this action.

III. The EPA's Proposed Responses to the Petitions

    Consistent with the Interim Guidance, the EPA's proposed responses
to the petitions are based on a consideration of the contribution that
each chemical makes to tropospheric ozone formation based on a
comparison of reactivity metrics, and our assessment that existing
programs or policies already adequately address the possibility that
granting each petition would pose a significant risk to human health or
the environment. We also believe that the

much lower global warming potential of HFO-1234yf compared to the
compound HFC-134a for which it will substitute, as described in Section
III.B, is an additional reason to approve the HFO-1234yf petition in
particular, given that applying the Interim Guidance itself supports
such approval. Information on these topics is given below.

A. Contribution to Tropospheric Ozone

    Table 1 presents three reactivity metrics for ethane (the benchmark
compound) and for HFO-1234yf and HFO-1234ze which are proposed for
exemption from the VOC definition in this proposed rule.

                           Table 1--Reactivities of Ethane, HFO-1234ze and HFO-1234yf
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                                                                                MIR  (g O3/mole   MIR (g O3/gram
                  Compound                       kOH  (cm\3\/molecule-sec)           VOC)              VOC)
----------------------------------------------------------------------------------------------------------------
Ethane......................................  2.4 x 10-\13\..................              8.4             0.28
HFO-1234yf..................................  10.5 x 10-\13\.................             31.92            0.28
HFO-1234ze..................................  9.25 x 10-\13\.................             11.2             0.098
----------------------------------------------------------------------------------------------------------------
Notes:
1. kOH value for ethane is from: R. Atkinson, D. L. Baulch, R. A. Cox, J. N. Crowley, R. F. Hampson, Jr., R. G.
  Hynes, M. E. Jenkin, J. A. Kerr, M. J. Rossi, and J. Troe (2004), Summary of evaluated kinetic and
  photochemical data for atmospheric chemistry.
2. kOH value for HFO-1234ze is from: R. Sondergaard, O. J. Nielsen, M. D. Hurley, T. J. Wallington, and R.
  Singh, ``Atmospheric chemistry of trans-CF3CH=CHF: kinetics of the gas-phase reactions with Cl atoms, OH
  radicals, and O3.'' Chemical Physics Letters, 443 (2007) 199-204.
3. kOH value for HFO-1234yf is from: O.J. Nielson, M.S. Javadi, M.P. Sulbaek Anderson, M.D. Hurley, T.J.
  Wallington, R. Singh, ``Atmospheric Chemistry of CF3CF=CH2: kinetics and mechanisms of gas-phase reactions
  with Cl atoms, OH Radicals, and O3,'' Chemical Physical Letters, 439 (2007) 18-22.
4. Maximum incremental reactivity or MIR (g O3/g VOC) values of ethane, HFO-1234ze and HFO-1234yf are from:
  William P. L. Carter, ``Development of the SAPRC-07 chemical mechanism and updated ozone reactivity scales''
  (updated 1/27/10). http://www.engr.ucr.edu/carter/SAPRC/saprc07.pdf.
5. Molar MIR (g O3/mole VOC) values were calculated from the mass MIR (g O3/g VOC) values by determining the
  number of moles per gram of the relevant organic compound.

    From the data in Table 1, it can be seen that HFO-1234yf has a
higher kOH value than ethane, meaning that it initially
reacts more quickly in the atmosphere than ethane. A molecule of HFO-
1234yf is also more reactive than a molecule of ethane, as shown by the
molar MIR (g O3/mole VOC) values, because equal numbers of
moles have equal numbers of molecules. However, a gram of HFO-1234yf
has the same reactivity as a gram of ethane. This is because HFO-1234yf
has a molecular weight (114) that is more than three times that of
ethane (molecular weight 30), and thus requires less than a third the
number of molecules of HFO-1234yf per gram than the number of molecules
of ethane per gram.
    From the data in Table 1, it also can be seen that HFO-1234ze has a
higher kOH value than ethane, meaning that it initially
reacts more quickly in the atmosphere than ethane. A molecule of HFO-
1234ze is also more reactive than a molecule of ethane, as shown by the
molar MIR (g O3/mole VOC) values, since equal numbers of
moles have equal numbers of molecules. However, a gram of HFO-1234ze is
less reactive, or creates less ozone on the day of its emission to the
atmosphere, than a gram of ethane. This is because HFO-1234ze has a
molecular weight (114) that is more than three times that of ethane
(molecular weight 30), and thus requires less than a third the number
of molecules of HFO-1234ze per gram than the number of molecules of
ethane needed per gram.
    Thus, for both of the petitions submitted by Honeywell, the data
supports the contention that the reactivity of the compound in the
petition is equal to or lower than that of ethane on a mass MIR basis.
    We anticipate that one of these compounds, HFO-1234yf, will be used
in automobiles as a replacement for the current refrigerant HFC-134a,
which is the only use for which HFO-1234yf has been approved to date
under the SNAP program. Given this one-for-one substitution situation,
it is informative to compare the ozone forming potential of HFO-1234yf
to that of HFC-134a, which has a gram MIR of only 0.0007 and thus
contributes very little to ozone formation. The EPA has considered the
results of a recent peer-reviewed study of the increase in ozone that
may occur as result of the substitution of HFO-1234yf for HFC-134a.\1\
Based on air quality modeling, this study found that if HFO-1234yf was
used in all automobiles but not in any other application, the
incremental amount of ozone formed from its degradation in the
atmosphere was only 0.01% of total ozone formed during the simulation
due to emissions from all sources. This portion of ozone formation due
to automobiles is slightly more than the current baseline, where the
refrigerant used is HCF-134a.\2\ Thus, the additional information from
this study shows that, under the assumptions used in the air quality
modeling, the use of HFO-1234yf would produce more ozone than continued
use of HFC-134a, but the increase is unlikely to have a significant
impact on local air quality. One of the assumptions used in the
modeling was that the substitution of one refrigerant for the other
would not affect meteorological conditions that also influence ozone
formation.
---------------------------------------------------------------------------

    \1\ D. Luecken, R. Waterland, S. Papasavva, K. Taddonio, W.
Hutzell, J. Rugh, and S. Andersen. Ozone and TFA Impacts in North
America from Degradation of 2,3,3,3-Tetrafluoropropene (HFO-1234yf),
A Potential Greenhouse Gas Replacement. Environ. Sci. Technol. 44,
pp. 343-349.
    \2\ The study also noted that if 2,3,3,3-tetrafluoropropene were
used in additional applications that are currently not legal in the
U.S, e.g., non-vehicle refrigerant applications, its contribution to
ozone formation would be greater, but did not quantify this
potential contribution.
---------------------------------------------------------------------------

    However, as stated in Section II.A, HFO-1234yf has a much lower GWP
than HFC-134a. Global warming is predicted to exacerbate high ozone
concentrations \3,4\, so directionally the lower GWP of HFO-1234yf will
offset at least some of the ozone increase predicted by the modeling
that assumed identical meteorological conditions. The EPA believes the
very small increase in ozone concentrations that may result from
encouraging the use of HFO-1234yf via an exemption from the

definition of VOC does not constitute a sufficient reason to depart
from the Interim Guidance's reliance on MIR comparisons to ethane as
the basis for approving VOC exemption requests.
---------------------------------------------------------------------------

    \3\ U.S. EPA. Assessment of the Impacts of Global Change on
Regional U.S. Air Quality: A Synthesis of Climate Change Impacts on
Ground-Level Ozone (An Interim Report of the U.S. EPA Global Change
Research Program). U.S. Environmental Protection Agency, Washington,
D.C., EPA/600/R-07/094F, 2009.
    \4\ Jacob, Daniel J. and Darrell A. Winner (2009). Effect of
climate change on air quality, Atmospheric Environment, 43:51-63.
---------------------------------------------------------------------------

    In summary, for both HFO-1234yf and HFO-1234ze, the EPA believes
that these chemicals qualify as negligibly reactive with respect to
their contribution to tropospheric ozone formation.

B. Likelihood of Risk to Human Health or the Environment

    Additionally, we examined and present available information on the
likelihood of risk to human health or the environment from increased
use of the chemicals considered here. We believe that current
regulation of these compounds under other EPA programs adequately
protects human health and the environment.
    The only currently known or potential uses for the chemicals being
considered here are as substitutes for stratospheric ozone-depleting
substances (ODS), and any such use is regulated under the SNAP program.
Under SNAP, the EPA reviews all new substitutes for ODS and allows
their use in specific applications where the overall risks to human
health and the environment associated with their use are comparable to
or less than those of other compounds used in the same manner.
    After reviewing available information and public comments regarding
its safety, health, and environmental risks and benefits under the SNAP
program, the EPA issued a final approval on March 29, 2011 (76 FR
174888) for HFO-1234yf as an acceptable ODS substitute for use in MVAC,
subject to specific use conditions, in place of CFC-12 and HFC-134a.\5\
The use conditions in the SNAP approval have the effect of making it
illegal to use HFO-1234yf in the air conditioning systems of heavy-duty
trucks, refrigerated transport, or off-road vehicles such as
agricultural or construction equipment. The use restrictions also have
the effect of making use of the compound other than by manufacturers of
automobiles and light-duty trucks or by commercial automotive service
centers either illegal or highly unlikely.\6\
---------------------------------------------------------------------------

    \5\ HFC-134a, which is not an ozone depleting substance, has
already largely replaced CFC-12 in motor vehicle air conditioners.
    \6\ While use by vehicle owners is not illegal, the SNAP
conditions prevent the sale of HFO-1234yf in containers of the size
that would be attractive to individual vehicle owners, and also
include requirements for special connecting equipment for the large
containers that are legal for sale. In addition, as described later
in this notice, under a recent Significant New Use Rule anyone
planning to distribute HFO-1234yf for use by a consumer would be
required to notify the EPA before doing so.
---------------------------------------------------------------------------

    In the SNAP review, the EPA found that the use of HFO-1234yf in new
passenger vehicle and light-duty truck MVAC systems, subject to the use
conditions, does not present a significantly greater risk to human
health and the environment compared to the currently approved MVAC
alternatives. In summary, the EPA's SNAP review reached the following
conclusions in support of this finding.
     Substituting HFO-1234yf for HFC-134a is environmentally
beneficial from a climate change perspective as the global warming
potential of HFO-1234yf is much lower (100 year GWP of 4 for HFO-1234yf
vs. 100 year GWP of 1430 for HFC-134a). The EPA received a petition on
May 7, 2010, (with a follow up petition on November 16, 2010) from the
Natural Resources Defense Council, the Institute for Governance &
Sustainable Development, and the Environmental Investigation Agency (a
non-governmental organization) asking the EPA to remove HFC-134a from
the list of acceptable substitutes under the SNAP program for use in
motor vehicle air conditioners. The petitioners cited this difference
in GWP as a reason for the EPA to approve their request.
     The use conditions of the final SNAP approval for HFO-
1234yf provide protection against potential safety hazards related to
the flammability of the compound, including potential exposure to
hydrogen fluoride arising from thermal decomposition during a fire.
     Like HFC-134a, HFO-1234yf is not an ODS, so the
substitution of the latter for the former will not affect stratospheric
ozone concentrations.
     HFO-1234yf will not create significant impacts on ground
level ozone or on local air quality.\7\
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    \7\ In support of this conclusion, the final SNAP rule preamble
cited two air quality modeling studies in addition to Luecken et al.
These studies focused on air quality in Los Angeles, as a worst case
scenario.
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     The production of triflouroacetic acid from the
atmospheric degradation of HFO-1234yf does not pose a significant risk
of aquatic toxicity or ecosystem impacts.
     When used in accordance with the SNAP use restrictions,
HFO-1234yf does not result in significantly greater risks to human
health than the use of other available or potentially available
substitutes.
    The EPA conclusion in the final SNAP action regarding human health
risks of HFO-1234yf was based on an extensive risk assessment and
review of public comments. The EPA also noted that under the TSCA, the
EPA had recently performed a pre-manufacture review for HFO-1234yf and
adopted the SNUR (75 FR 65987, Oct. 27, 2010). The SNUR for HFO-1234yf
requires reporting of additional information to the EPA before sale may
begin for uses beyond air conditioning in new automobiles or commercial
servicing of new automobiles built using HFO-1234yf, i.e., the EPA must
be given 90-days notice before HFO-1234yf products can be sold directly
to consumers for the purpose of servicing, maintenance, and disposal.
During these 90 days, the EPA can take further action to stop that
marketing. This precautionary step was taken because of certain animal
data indicating toxicity, and the possibility that home mechanics might
accidentally expose themselves. Auto plant workers and repair shop
professionals were expected to avoid exposure through work
practices.\8\
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    \8\ The EPA considered the results of developmental testing
available at the time of the final SNUR action to be of some
concern, but not a sufficient basis to find HFO-1234yf unacceptable
under the SNUR determination. As a result, The EPA requested
additional toxicity testing and issued the SNUR for HFO-1234yf. The
EPA has received and is presently reviewing the results of the
additional toxicity testing. The EPA continues to believe that HFO-
1234yf, when used in new automobile air conditioning systems in
accordance with the use conditions under the SNAP rule, does not
result in significantly greater risks to human health than the use
of other available substitutes.
---------------------------------------------------------------------------

    Under the SNUR, the agency will: (a) Receive a Significant New Use
Notice, or SNUN, of any person's intent to manufacture, import, or
process HFO-1234yf for sale directly to consumers; (b) have an
opportunity to review and evaluate data submitted with the SNUN; and
(c) be able to regulate HFO-1234yf consumer products, if warranted. Any
other potential applications beyond air conditioning in new automobiles
or commercial servicing of new automobiles built using HFO-1234yf that
may lead to significant exposures will also trigger the requirement for
a SNUN, and would likely trigger further review under SNAP. The EPA
believes these processes will provide adequate opportunity to address
any health effects issues associated with possible increased use of
HFO-1234yf.
    The EPA's SNAP program has also issued determinations of
acceptability for HFO-1234ze as an acceptable substitute for certain
ODS in a number of foam blowing end uses, as a refrigerant in non-
mechanical heat transfer, and as a propellant as stated in Section I.
In this action, the EPA noted that HFO-1234ze is not ozone

depleting, the GWP for HFO-1234ze is significantly lower than the GWPs
for the ozone-depleting substances it will replace, HFO-1234ze is not
flammable, and the toxicity risks of HFO-1234ze are low. For these
reasons, the EPA found that HFO-1234ze will not pose a greater overall
risk to human health and the environment than the other substitutes
acceptable in these end uses.

C. Conclusions

    In summary, for both HFO-1234yf and HFO-1234ze, the EPA believes
that (a) these chemicals qualify as negligibly reactive with respect to
their contribution to tropospheric ozone formation, and (b) any non-
tropospheric ozone related risks associated with potential increased
use are adequately addressed by other existing programs and policies.
We also believe that the much lower global warming potential of HFO-
1234yf compared to the compound HFC-134a for which it will substitute,
as described in Section III.B, is an additional reason to approve the
HFO-1234yf petition in particular, given that applying the Interim
Guidance itself supports such approval. We invite the public to submit
comments and additional information relevant to the issue of these
compounds' overall risks and benefits to human health and the
environment, and on whether such information should be considered in
connection with the decision to grant an exemption from the regulatory
definition of VOC.

IV. Proposed Action

    The EPA is responding to the petitions by proposing to revise its
definition of VOC at 40 CFR 51.100(s) to add HFO-1234yf and HFO-1234ze
to the list of compounds that are exempt from the regulatory definition
of VOC because they are negligibly reactive on the basis that they are
less reactive than ethane on a mass MIR basis. If an entity uses or
produces any of these two compounds and is subject to the EPA
regulations limiting the use of VOC in a product, limiting the VOC
emissions from a facility, or otherwise controlling the use of VOC for
purposes related to attaining the ozone NAAQS, then these two compounds
will not be counted as a VOC in determining whether these regulatory
obligations have been met. This action may also affect whether any of
these two compounds are considered as VOCs for state regulatory
purposes to reduce ozone formation, if a state relies on the EPA's
definition of VOC. States are not obligated to exclude from control as
a VOC those compounds that the EPA has found to be negligibly reactive.
However, if this action is made final, states may not take credit for
controlling these compounds in their ozone control strategies.

V. Statutory and Executive Order Reviews

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

    Under Executive Order (EO) 12866 (58 FR 51735, October 4, 1993),
this action is treated as a significant regulatory action because some
may view it as raising novel legal or policy issues arising out of
legal mandates. Accordingly, the EPA submitted this action to the
Office of Management and Budget (OMB) for review under EO 12866 and
13563 (76 FR 3821, January 21, 2011) and any changes made in response
to OMB recommendations have been documented in the docket for this
action.

B. Paperwork Reduction Act

    This action does not impose an information collection burden under
the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.
Burden is defined at 5 CFR 1320.3(b). It does not contain any
recordkeeping or reporting requirement.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements under the Administrative
Procedure Act or any other statute unless the agency certifies that the
proposed rule will not have a significant economic impact on a
substantial number of small entities. Small entities include small
businesses, small organizations, and small governmental jurisdictions.
For purposes of assessing the impacts of this notice on small entities,
small entity is defined as: (1) A small business that is a small
industrial entity as defined in the U.S. Small Business Administration
(SBA) size standards. (See 13 CFR 121.); (2) A governmental
jurisdiction that is a government of a city, county, town, school
district or special district with a population of less than 50,000; and
(3) A small organization that is any not-for-profit enterprise which is
independently owned and operated and is not dominant in its field.
    After considering the economic impacts of this proposed rule on
small entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. This
proposed rule will not impose any requirements on small entities.
    We continue to be interested in the potential impacts of the
proposed rule on small entities and welcome comments on issues related
to such impacts.

D. Unfunded Mandates Reform Act

    This action contains no Federal mandates under the provisions of
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C.
1531-1538 for state, local, or Tribal governments or the private
sector. The action imposes no enforceable duty on any state, local or
Tribal governments, or the private sector. Therefore, this action is
not subject to the requirements of sections 202 and 205 of the UMRA.
    This action is also not subject to the requirements of section 203
of UMRA because it contains no regulatory requirements that might
significantly or uniquely affect small governments.

E. Executive Order 13132--Federalism

    This action does not have federalism implications. It will not have
substantial direct effects on the states, on the relationship between
the national government and the states, or on the distribution of power
and responsibilities among the various levels of government, as
specified in Executive Order 13132. This action addresses the exemption
of a set of chemical compounds from the VOC definition. Thus, Executive
Order 13132 does not apply to this rule. In the spirit of Executive
Order 13132, and consistent with the EPA policy to promote
communications between the EPA and state and local governments, the EPA
specifically solicits comment on this proposed rule from state and
local officials.

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

    This action does not have Tribal implications, as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). It will not have
substantial direct effects on Tribal governments, on the relationship
between the Federal government and Indian Tribes, or on the
distribution of power and responsibilities between the Federal
government and Indian Tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule.
    Although Executive Order 13175 does not apply to this proposed
rule, the EPA specifically solicits additional comment on this proposed
rule from Tribal officials.

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

    This action is not subject to EO 13045 (62 FR 19885, April 23,
1997) because it is not economically significant as defined in EO
12866. While this proposed rule is not subject to the Executive Order,
the EPA has reason to believe that ozone has a disproportionate effect
on active children who play outdoors (62 FR 38856; 38859, July 18,
1997). The EPA has not identified any specific studies on whether or to
what extent these chemical compounds may affect children's health. The
EPA has placed the available data regarding the health effects of HFO-
1234yf in Docket No. EPA-HQ-OAR-2003-0032 which is the docket for the
SNUR for this compound.
    The public is invited to submit comments or identify peer-reviewed
studies and data, of which the EPA may not be aware, that assess
results of early life exposure to the chemical compounds herein.

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

    This action is not a ``significant energy action'' as defined in
Executive Order 13211, ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001) because it is not likely to have a significant
adverse effect on the supply, distribution, or use of energy. This
action proposes to revise the EPA's definition of VOCs for purposes of
preparing SIPs to attain the NAAQS for ozone under title I of the CAA.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Public Law 104-113, section 12(d), (15 U.S.C.
272 note) directs the EPA to use voluntary consensus standards in its
regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impractical. Voluntary consensus standards
are technical standards (e.g., materials specifications, test methods,
sampling procedures, and business practices) that are developed or
adopted by voluntary consensus standards bodies. The NTTAA directs the
EPA to provide Congress, through OMB, explanations when the agency
decides not to use available and applicable voluntary consensus
standards. This rulemaking does not involve technical standards.
Therefore, the EPA is not considering the use of any voluntary
consensus standards.

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

    Executive Order (EO) 12898 (59 FR 7629, Feb. 16, 1994) establishes
Federal executive policy on environmental justice. Its main provision
directs Federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    The EPA has determined that this proposed rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations because it will not
affect the level of protection provided to human health or the
environment.

List of Subjects in 40 CFR Part 51

    Environmental protection, Administrative practice and procedure,
Air pollution control, Ozone, Reporting and recordkeeping requirements,
Volatile organic compounds.

    Dated: October 11, 2011.
Lisa P. Jackson,
Administrator.
    For reasons set forth in the preamble, part 51 of chapter I of
title 40 of the Code of Federal Regulations is proposed to be amended
as follows:

PART 51--REQUIREMENTS FOR PREPARATION, ADOPTION, AND SUBMITTAL OF
IMPLEMENTATION PLANS

    1. The authority citation for Part 51, Subpart F, continues to read
as follows:

     Authority: 42 U.S.C. 7401, 7411, 7412, 7413, 7414, 7470-7479,
7501-7508, 7601, and 7602.

Sec.  51.100  [Amended]

    2. Section 51.100 is amended at the end of paragraph (s)(1)
introductory text by removing the words ``and perfluorocarbon compounds
which fall into these classes:'' and adding in their place a semi-colon
and the words ``trans-1,3,3,3-tetrafluoropropene; 2,3,3,3-
tetrafluoropropene and perfluorocarbon compounds which fall into these
classes:''.

[FR Doc. 2011-26768 Filed 10-14-11; 8:45 am]
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