ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 112

[EPA-HQ-OPA-2008-0821; FRL- ]

RIN 2050-AG50 

Oil Pollution Prevention; Spill Prevention, Control, and Countermeasure (SPCC) Rule –

Amendments for Milk Containers

AGENCY: Environmental Protection Agency.

ACTION: Final rule.

SUMMARY: The U.S. Environmental Protection Agency (EPA or the Agency) is amending the Spill 

Prevention, Control, and Countermeasure (SPCC) rule to exempt all milk and milk product containers

and associated piping and appurtenances from the SPCC requirements. The Agency is also removing 

the compliance date requirements for the exempted containers.

DATES: This final rule is effective on [INSERT DATE 60 DAYS FROM PUBLICATION IN THE 

FEDERAL REGISTER]

ADDRESSES: The public docket for this rulemaking, Docket ID No. EPA-HQ-OPA-2008-0821, 

contains the information related to this rulemaking, including the response to comments document. All 

documents in the docket are listed in the index at http://www.regulations.gov. Although listed in the 

index, some information may not be publicly available, such as Confidential Business Information (CBI) 

or other information the disclosure of which 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 at http://www.regulations.gov or in hard copy at the EPA docket, 

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 
2

telephone number of the Public Reading Room is 202-566-1744, and the telephone number to make an 

appointment to view the docket is 202-566-0276.

FOR FURTHER INFORMATION CONTACT: For general information, contact the Superfund, TRI, 

EPCRA, RMP, and Oil Information Center at 800-424-9346 or TDD at 800-553-7672 (hearing 

impaired). In the Washington, D.C. metropolitan area, contact the Superfund, TRI, EPCRA, RMP, and 

Oil Information Center at 703-412-9810 or TDD 703-412-3323. For more detailed information on 

specific aspects of this final rule, contact either Gregory Wilson at 202-564-7989 

(wilson.gregory@epa.gov) or, Vanessa E. Principe at 202-564-7913 (principe.vanessa@epa.gov), U.S. 

Environmental Protection Agency, 1200 Pennsylvania Avenue, NW, Washington, D.C., 20460-0002, 

Mail Code 5104A.

SUPPLEMENTARY INFORMATION: The contents of this preamble are:

I. General Information 3

II. Entities Potentially Affected by This Final Rule 4

III. Statutory Authority and Delegation of Authority 4

IV. Background 5

V. This Action 7

A. Finalize Modified Amendments.................................................................................................. 7

1. Industry Sanitary Standards and Construction Requirements..................................................... 8

2. Summary of Comments............................................................................................................... 9

3. Response to Comments............................................................................................................. 11

4. Universe Affected by this Action.............................................................................................. 18

B. Removal of Compliance Date for Exempted Containers, Associated Piping and

Appurtenances............................................................................................................... 19
3

VI. Statutory and Executive Order Reviews 20

A. Executive Orders 12866 and 13563: Regulatory Planning and Review................................... 20

B. Paperwork Reduction Act ......................................................................................................... 21

C. Regulatory Flexibility Act......................................................................................................... 21

D. Unfunded Mandates Reform Act .............................................................................................. 23

E. Executive Order 13132: Federalism.......................................................................................... 24

F. Executive Order 13175: Consultation and Coordination with Indian Tribal Governments..... 24

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

Risks............................................................................................................................................... 25

H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy

Supply, Distribution, or Use .......................................................................................................... 25

I. National Technology Transfer and Advancement Act............................................................... 25

J. Executive Order 12898: Federal Actions to Address Environmental Justice in Minority

Populations and Low-Income Populations.................................................................................... 26

K. Congressional Review Act........................................................................................................ 26

I. General Information

On January 15, 2009, EPA proposed to amend the Spill Prevention, Control, and 

Countermeasure (SPCC) rule to tailor and streamline the requirements for the dairy industry. 

Specifically, EPA proposed to exempt milk containers and associated piping and appurtenances from the 

SPCC requirements provided they are constructed according to the current applicable 3-A Sanitary

Standards, and are subject to the current applicable Grade “A” Pasteurized Milk Ordinance (PMO) or a 

State dairy regulatory requirement equivalent to the current applicable PMO. The Agency is modifying

the proposed exemption to exempt all milk containers, and associated piping and appurtenances and is 
4

further extending the exemption to also include all milk product containers, and associated piping and 

appurtenances. Finally, the Agency is removing the compliance date requirements for the exempted 

containers. 

EPA estimates that dairy farms will incur an average annualized savings of $133 million and 

milk product manufacturing plants an average annualized savings of $13 million (estimates based on 

2009$ and a 7% discount rate). In aggregate, the total annualized savings is estimated at $146 million. 

The Regulatory Impact analysis, which can be found in the docket, provides more detail of the cost 

savings and methodology.

Cost and Benefits of the Final Rule 

Annualized Cost Savings

Discounted at 3% Discounted at 7%

Costs $0 $0

Benefits (Cost Savings) $143 $146

Net Benefits (Benefits – Costs) $143 $146

II. Entities Potentially Affected by This Final Rule

Industry Sector NAICS Code

Farms................................................................. 111, 112

Food Manufacturing............................................. 311

The Agency’s goal is to provide a guide for readers to consider regarding entities that potentially

could be affected by this action. However, this action may affect other entities not listed in this table. If 

you have questions regarding the applicability of this action to a particular entity, consult the person 

listed in the preceding section entitled FOR FURTHER INFORMATION CONTACT.

III. Statutory Authority and Delegation of Authority

Section 311(j)(1)(C) of the Clean Water Act (CWA or the Act), 33 U.S.C. 1321(j)(1)(C), 

requires the President to issue regulations establishing procedures, methods, equipment, and other 

requirements to prevent discharges of oil to navigable waters or adjoining shorelines from vessels and 
5

facilities and to contain such discharges. The President delegated the authority to regulate nontransportation-related onshore facilities to EPA in Executive Order 11548 (35 FR 11677, July 22, 1970), 

which was replaced by Executive Order 12777 (56 FR 54757, October 22, 1991). A Memorandum of 

Understanding (MOU) between the U.S. Department of Transportation (DOT) and EPA (36 FR 24080, 

November 24, 1971) established the definitions of transportation-related and non-transportation-related 

facilities. An MOU between EPA, the U.S. Department of the Interior (DOI), and DOT (59 FR 34102, 

July 1, 1994) re-delegated the responsibility to regulate certain offshore facilities from DOI to EPA.

In 1995, Congress enacted the Edible Oil Regulatory Reform Act (EORRA), 33 U.S.C. 2720, 

which mandates that Federal agencies,2in issuing or enforcing any regulation or establishing any 

interpretation or guideline relating to the transportation, storage, discharge, release, emission or disposal 

of oil, differentiate between and establish separate classes for the various types of oils, specifically:

animal fats and oils and greases, and fish and marine mammal oils; oils of vegetable origin; other nonpetroleum oils and greases; and petroleum oils. In differentiating between these classes of oils, Federal 

agencies are directed to consider differences in the physical, chemical, biological, and other properties, 

and in the environmental effects of the classes.

IV. Background

EPA promulgated a series of amendments to the SPCC rule in December 2006, December 2008 

and November 2009 that provided the facility owner or operator with significant flexibility to comply

with the SPCC regulatory requirements. Facilities handling animal fats and vegetable oils (AFVOs), 

subject to the SPCC rule because of their oil storage capacity, may benefit from a number of these 

amendments, which tailored prevention and control measures to the facility type and oils being stored. 

The provisions included streamlined requirements for qualified facilities and reduced requirements for a 

 

2 The requirements of the Edible Oil Regulatory Reform Act do not apply to the Food and Drug Administration and the Food 

Safety and Inspection Service.
6

subset of those qualified facilities. The rule also amended the security, integrity testing, and facility 

diagram requirements, while exemptions were provided for pesticide application equipment and related 

mix containers, and for single-family residential heating oil containers. Finally, the amendments offered 

clarifications for fuel nurse tanks, wind farms and for the definition of “facility.”

Milk typically contains a percentage of animal fat, a non-petroleum oil. Thus, containers storing 

milk and milk products are currently subject to the SPCC rule when they meet the applicability criteria 

set forth in §112.1. In the SPCC rule, the term “bulk storage container” is defined at §112.2 as “any 

container used to store oil.” Therefore, bulk storage containers storing milk are currently subject to the 

applicable provisions under §112.12. Additionally, milk is processed in containers during the 

pasteurization process. These continuous pasteurizers, while not bulk storage containers, are considered 

oil filled-manufacturing equipment and are currently subject to the general provisions of the SPCC rule 

under §112.7. Finally, milk is also handled and transferred through piping and appurtenances associated 

with containers which are currently subject to certain provisions of the SPCC rule.

In response to EPA’s October 2007 proposal for amendments to the SPCC rule (72 FR 58378, 

October 15, 2007), several comments requested that EPA exempt containers used to store milk from the 

SPCC requirements. Specifically, these comments suggested that milk storage containers be exempted 

from the SPCC requirements because the Grade “A” PMO addresses milk storage and tank integrity. 

The comments identified the PMO, which specifically addresses milk intended for human consumption, 

as a model ordinance maintained through a cooperative agreement between the States, the Food and 

Drug Administration (FDA), and the regulated community. States typically adopt the PMO either by 

reference, or by directly incorporating similar requirements into their statutes or regulations. 

Thus, on January 15, 2009, the Agency published a proposal to exempt from SPCC requirements 

milk containers and associated piping and appurtenances provided they are constructed according to 
7

current applicable 3-A Sanitary Standards, and are subject to the current applicable PMO or a State dairy

regulatory requirement equivalent to the current applicable PMO [74 FR 2463].

The Agency also requested comment on an exemption for milk product containers and their 

associated piping and appurtenances from the SPCC rule provided they are constructed in accordance 

with the current applicable 3-A Sanitary Standards, and are subject to the current applicable Grade “A” 

PMO sanitation requirements or a State dairy regulatory equivalent to the current applicable PMO. In 

addition, the Agency requested comment on how to address milk storage containers (including totes) 

that may not be constructed to 3-A Sanitary Standards under the SPCC rule and whether they should 

also be exempted from the SPCC requirements, provided they are subject to the current applicable Grade 

“A” PMO or a State dairy regulatory requirement equivalent to the current applicable PMO. Finally, the 

Agency requested comment on alternative approaches to address milk and milk product containers, 

associated piping and appurtenances under the SPCC rule. 

After the Agency’s review of comments and consideration of all relevant facts, today’s rule 

modifies the proposed exemption to exempt all milk containers, and associated piping and 

appurtenances and further extends the exemption to include all milk product containers, and associated 

piping and appurtenances. The Agency is also removing the compliance date requirements for the 

exempt containers. 

V. This Action

A. Finalize Modified Amendments 

The Agency is exempting from the SPCC requirements milk and milk product containers, and 

associated piping and appurtenances. Additionally, the capacity of these exempted containers, and

associated piping and appurtenances is not to be included in a facility’s total oil storage capacity 

calculation (see 112.1(d)(2)(ii)). The Agency is also removing the compliance date requirements for the 
8

exempted containers.

This preamble discusses these provisions, and any related comment received during the 2009 

comment period, that raised substantive policy issues. For a complete discussion of the comments 

received in 2009, see Comment and Response Document Oil Pollution Prevention; SPCC Plan 

Requirements – Amendments [INSERT DATE], a copy of which is available in the docket for this 

rulemaking.

1. Industry Sanitary Standards and Construction Requirements 

Milk and milk product containers and their associated piping and appurtenances are generally 

constructed according to an industry standard established by the 3-A Sanitary Standards organization (3-

A Sanitary Standards, Inc., McLean, VA, http://www.3-a.org) which satisfy the PMO model code 

construction requirements for milk and milk product containers and associated piping and 

appurtenances. These containers, associated piping and appurtenances may also be subject to the US 

Department of Agriculture (USDA) Recommended Requirements for Milk for Manufacturing Purposes 

and its Production and Processing (Milk for Manufacturing Purposes and Its Production and 

Processing; Requirements Recommended for Adoption by State Regulatory Agencies; see 

http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELDEV3004791). All milk handling 

operations subject to the PMO are required to have an operating permit, and are subject to inspection by

state dairy regulatory agencies. The PMO model code establishes criteria for the permitting, inspection 

and enforcement of milk handling equipment and operations that govern all processes for milk intended 

for human consumption. 

Likewise, USDA has developed and maintains a set of model regulations relating to quality and 

sanitation requirements for the production and processing of manufacturing grade milk, which are 

recommended for adoption and enforcement by the various States that regulate manufacturing grade 
9

milk. The purpose of the model requirements is to promote uniformity in State dairy laws and 

regulations relating to manufacturing grade milk. These recommended requirements contain criteria 

similar to those of the PMO for milk for manufacturing purposes, including its processing, use, labeling 

and storage. Furthermore, these requirements include provisions for inspections, certification and 

licensing of facilities that handle and process milk for manufacturing purposes and its products. These 

requirements serve as the basis for the exemption of milk and milk product containers, and their 

associated piping and appurtenances from the SPCC rule. Milk and milk product containers, associated 

piping and appurtenances are generally constructed in accordance with standards like the current 

applicable 3-A Sanitary Standards, and are subject to standards like the current applicable PMO 

sanitation requirements, USDA Recommended Requirements for Milk for Manufacturing Purposes and 

its Production and Processing, or equivalent State dairy regulations. The 3-A Sanitary Standards for 

equipment construction require the use of durable materials and sanitary construction criteria that can be 

easily maintained and kept clean and free of defects when appropriate cleaning procedures and 

chemicals are used. Both the PMO sanitation requirements and the USDA Recommended Requirements 

include construction and sanitation standards and frequent State and/or Federal inspections for these 

containers, piping and appurtenances, and provide definitions and/or list those milk and milk products to 

which they apply. State dairy requirements for permits/licenses, operations and inspections are 

generally structured to be equivalent to the current applicable PMO requirements and/or USDA 

Recommended Requirements. The Agency believes the combination of these specific standards and 

requirements address the prevention of oil discharges. 

2. Summary of Comments

Support for an Expanded Exemption. There was only one comment to the 2009 proposal, and it 

expressed general support for the exemption. The comment requested that EPA consider exempting all 
10

milk and milk products, including cheese, cream, yogurt and ice cream mix. The comment stated these 

products and their containers do not present a potential for spills into navigable waters of the United 

States because the equipment must be constructed to preclude deterioration and must be maintained to 

keep it clean and free of defects. The comment states that all dairy processing equipment, storage 

containers, piping and appurtenances are made of high grade stainless steel (with the exception of some 

cheese storage containers) and are designed and constructed in accordance with 3-A and/or FDA’s 

Current Good Manufacturing Practices (CGMP) or equivalents. The comment also states that other 

requirements mandate frequent inspection of dairy operations for defects in equipment thereby making 

spillage and leakage highly improbable. 

Exemption of Solid Mixtures. The comment also requested that EPA exempt cheese and other 

mixtures that are solid at room temperature from the SPCC requirements. The comment included as an 

appendix a letter commenting on an earlier Agency action and requested an exemption of substances 

that are solid at ambient temperatures (including animal fats). The comment also stated that should a 

cheese production or storage facility catch fire, “under no circumstances would cheese liquefy and flow” 

out of the facility to potentially pollute or endanger navigable waters of the United States. 

Expand the Scope of Regulations and Standards To Qualify the Exemption. The comment 

requested that EPA broaden the scope of regulatory requirements and construction standards to exempt 

additional containers from the SPCC rule, specifically those that are subject to the Food and Drug 

Administration (FDA) requirements under 21 CFR Part 110. The comment suggested the exemption 

state: “the SPCC rule does not apply to storage containers and associated piping and appurtenances that 

contain milk or milk products that are: a) subject to the construction requirements of 3-A Sanitary

Standards or the equivalent standards approved by a federal, state or local regulatory authority, and b) 

are subject to 21 CFR Part 110, the PMO, or a state or local equivalent.” Additionally, the comment 
11

argued that, along with high sanitation standards for edible fats and oils, regulations issued by the 

Occupational Safety and Health Administration (OSHA) for worker safety address storage and use of 

oils at food facilities, thereby reducing the likelihood, rate and magnitude of a spill should an accident 

occur. 

Definition of Oil and Oil Mixtures. The comment also argued milk and milk products should not 

be defined as oil. The comment incorporates by reference statements that milk and other dairy products 

do not seem to meet the definition of “oil” because milk, ice cream mix, yogurt, cream, cheese and other 

dairy products are not (1) fat, oil or grease or (2) fat, oil or grease mixed with waste. The comment 

included as an appendix a letter to the Agency commenting on a separate action, stating there are 

minimal environmental risks resulting from edible fats and oils spills and EPA should exempt 

substances not listed on the U.S. Coast Guard list of petroleum and non-petroleum oils (e.g., milk or 

milk products). The comment requests EPA clarify the definition of oil and oil mixtures so that lower 

fat mixtures, e.g., those below 50 percent fat, or those that are solid at room temperature might not be 

considered oil, thereby exempting most milk and milk products from the SPCC requirements. The 

commenter further requested EPA not initiate any enforcement actions against operations where there is 

substantial doubt regarding whether substances at those facilities are within the scope of the SPCC rule 

until EPA has clarified oil mixtures. 

3. Response to Comments

Support for an Expanded Exemption. EPA recognizes the merits to arguments supporting an 

exemption for milk product containers. Thus, EPA is amending the proposed exemption by exempting 

all milk containers, and associated piping and appurtenances and by further extending the exemption to 

include all milk product containers, and associated piping and appurtenances. The exempted containers 

include all milk and milk product containers as defined in the PMO model code, but also all milk and 
12

milk product containers subject to the USDA Recommended Requirements for Milk for Manufacturing 

Purposes and its Production and Processing. EPA also acknowledges that some milk and milk product 

handling operations are subject to 21 CFR 110. However, EPA believes that the dairy specific 

standards above apply to the vast majority of milk and milk product containers. The Agency could not 

identify any milk or milk product containers that are not subject to PMO, USDA Recommended 

Requirements for Milk for Manufacturing Purposes and its Production and Processing, or equivalent 

State dairy regulatory requirements and thus the final rule exempts all milk and milk product containers 

from the SPCC requirements.

In this final rule, EPA is amending the scope of the exemption by exempting all milk containers, 

and associated piping and appurtenances and by further expanding the exemption to include all milk 

product containers, and associated piping and appurtenances. These exempted milk and milk product 

containers, and associated piping and appurtenances are constructed according to standards like the 

current applicable 3-A Sanitary Standards, and are subject to standards like the current applicable Grade 

“A” (PMO), USDA Recommended Requirements for Milk for Manufacturing Purposes and its 

Production and Processing, or equivalent State dairy regulatory requirements. Because of their 

operational requirements, particularly for permits/licenses and frequent inspections, the Agency expects 

the owner or operator of a facility with milk and milk product containers subject to the 3-A Sanitary

Standards, and PMO requirements, USDA Recommended Requirements for Milk for Manufacturing 

Purposes and its Production and Processing, or equivalent State dairy regulatory requirements, to be in 

compliance with those provisions in order to maintain their operations. For the purposes of this 

provision, “equivalent” means a State dairy regulation that includes all the components of the PMO 

model code and/or the USDA Recommended Requirements. All milk and/or milk product transfer and 

processing activities are included in the scope of this exemption from the SPCC rule. 
13

Exemption of Solid Mixtures. EPA disagrees that all oils or oil mixtures that are solid at room 

temperature should, as a general matter, be exempted from the SPCC rule. Vegetable oils and animal 

fats that are solid at room temperature serve as potent physical contaminants and are more difficult to 

remove from affected animals than petroleum oil (see 62 FR 54511, October 20, 1997). 

The Agency believes that spill prevention for milk and milk products produced for processing 

and manufacturing (e.g., butter, cheese, dry milk) are appropriately addressed through standards like the 

PMO model code, the USDA Recommended Requirements for Milk for Manufacturing Purposes and its 

Production and Processing, or equivalent State dairy regulatory requirements, and thus is extending the 

exemption to include all milk and milk product containers, associated piping and appurtenances.

To decide whether a facility is subject to the SPCC rule, the owner or operator must first identify

whether there is a reasonable expectation of an oil discharge to navigable waters or adjoining shorelines 

from the facility. The owner or operator of a facility may consider the nature and flow properties of the 

oils handled at the facility to make this determination (for more information, see Chapter 2 of the SPCC 

Guidance for Regional Inspectors). If there is a reasonable expectation that any oil (in any container) at 

the facility may impact waters if discharged, then the next step is to determine the aboveground and 

completely buried storage capacity of all oil located at the facility (except for exempt containers). If the 

aboveground storage capacity is greater than 1,320 U.S. gallons or the completely buried capacity is 

greater than 42,000 U.S. gallons, then the facility is subject to the SPCC rule and the owner or operator 

must develop an SPCC Plan that describes oil handling operations, spill prevention practices, discharge 

or drainage controls, and the personnel, equipment and resources at the facility that are used to prevent 

oil spills from reaching navigable waters or adjoining shorelines. However, if the owner or operator of 

the facility determines there is not a reasonable expectation of discharge of oil to navigable waters or 
14

adjoining shorelines from all oils stored at the facility then the facility is not subject to the SPCC 

requirements. We recommend that the owner or operator document and date these determinations in the 

event that EPA challenges the determination following an inspection.

The SPCC rule is primarily a performance-based rule, therefore, the owner or operator may

consider the properties of each oil located at the facility to identify measures and procedures to prevent 

spills from the facility. For example, storage of an oil in solid form inside a building may provide 

adequate secondary containment. Additionally, many SPCC rule provisions allow for environmentally

equivalent alternatives to be used (except for secondary containment) provided they are documented in 

the Plan and certified by a Professional Engineer (see Chapter 3 of the SPCC Guidance for Regional 

Inspectors for more information).

Expand the Scope of Regulations and Standards To Qualify the Exemption. EPA agrees that the 

scope of the exemption should apply to all milk and milk product containers because they are subject to 

a combination of standards like the 3-A Sanitary Standards with either PMO or the USDA requirements 

or state equivalent dairy regulations. EPA is expanding the exemption because non-PMO milk and milk 

product containers are subject to standards like the USDA Recommended Requirements for Milk for 

Manufacturing Purposes and its Production and Processing, or equivalent State dairy regulations. The 

Agency believes the components of these requirements are comparable to the PMO requirements.

Specifically, both PMO and USDA Recommended Requirements have provisions that include 

permitting/licensing, inspections, construction standards, operations, maintenance, enforcement and 

other sanitation requirements. 

All milk and milk product handling operations subject to the PMO and USDA Recommended 

Requirements must have an operating permit or license, and are subject to inspection by state dairy

regulatory agencies. Both the PMO and the USDA Recommended Requirements establish criteria for 
15

the permitting/licensing, inspection and enforcement of handling equipment and operations that typically

govern processes for milk and milk products intended for human consumption and for milk produced for 

processing and manufacturing products for human consumption. These include, but are not limited to, 

specifications for the design and construction of milk and milk product handling equipment, equipment 

sanitation and maintenance procedures, temperature controls, and pasteurization standards. In addition, 

because many kinds of harmful bacteria can grow rapidly in milk and milk products, and thus, to ensure 

a proper sanitary environment, standards like both the PMO and the USDA Recommended 

Requirements require that milk and milk product containers be frequently emptied, cleaned, inspected 

and sanitized and that records of such events be maintained. Such frequent cleaning and inspection of 

the containers suggests that any leaks or deterioration of container integrity would be quickly identified. 

PMO and USDA Recommended Requirements also require inspections of facilities with such milk and 

milk products handling operations by the state-designated regulatory agency prior to issuing a permit or 

license, and routine inspections thereafter (for example, at dairy farms covered by PMO at least once 

every six months) by a state designated regulatory agency. Inspections at these facilities encompass 

those elements associated with the milk and milk products operation, including the containers, and 

associated piping and appurtenances. Violations of the permitting or licensing requirements may result 

in the suspension or revocation of the facility’s operating license or permit. 

USDA regulations, guidelines and recommended requirements all recognize the unique nature in 

which milk and milk products are handled and stored in contrast to other oils intended for human 

consumption. Subpart D - Farm Requirements for Milk for Manufacturing of the USDA Recommended 

Requirements for Milk for Manufacturing Purposes and its Production and Processing requires that farm 

bulk tanks meet 3-A Sanitary Standards for construction at the time of installation, that they be installed 

in accordance with USDA regulations, and that all new utensils and equipment be in compliance with 
16

applicable 3-A Sanitary Standards. Furthermore USDA regulation under 7 CFR 58.128(d) requires new 

or replacement storage tanks or vats to comply with the appropriate 3–A Sanitary Standards (i.e., 

Storage Tanks for Milk and Milk Products or Sanitary Standards for Silo-Type Storage Tanks for Milk 

and Milk Products). FDA, USDA, and the states representatives are active members of the 3A Steering 

Committee. (http://www.3-a.org/standards/pdf/steeringroster.pdf) According to USDA Guidelines for 

the Sanitary Design and Fabrication of Dairy Processing Equipment, "Dairy Grading Branch policy fully

supports and utilizes established 3-A Sanitary Standards and Accepted Practices." Furthermore the 

document says "When a USDA-Dairy Grading Branch review is requested of equipment for which there 

are no 3-A Sanitary Standards or Accepted Practices, USDA will use the general criteria, guidelines, and 

principles outlined in this document. These criteria, guidelines, and principles are consistent with those 

utilized by the 3-A Sanitary Standards Committees during the development of standards and accepted 

practices."

Although OSHA worker safety regulations may apply to facilities with milk or milk product 

containers, their requirements specifically focus on worker safety and do not address container design or 

container inspection practices as in the case of the PMO or USDA requirements and the 3-A Sanitary 

Standards. The FDA requirements under 21 CFR Part 110, are current good manufacturing practices in 

manufacturing, packing, or holding human food and apply to all foods under FDA jurisdiction; whereas 

PMO and USDA requirements are specific to milk and milk products. The PMO model code and the 

USDA Recommended Requirements are specific to milk and milk products and serve to minimize their 

potential for discharge because they include permitting or licensing of facilities, strict inspection 

frequencies and enforcement procedures, among others. The monitoring and sanitation standards under 

PMO and USDA serve in part as spill prevention measures because the frequent cleaning and 

inspections of the milk and milk product containers, associated piping and appurtenances leads to early
17

identification of equipment failure, and spill detection. Failure to comply with these provisions may lead 

to a suspension of licenses or permits issued under PMO or USDA. 

Definition of Oil and Oil Mixtures. EPA does not agree with the comment that milk is not an oil. 

Milk and other milk products comprised of animal fats meet both the definition of oil and of nonpetroleum oil included in §112.2 of the rule. EPA has an established record of including animal fats and 

vegetable oils in planning and spill prevention requirements (see 40 FR 28849, July 9, 1975; and 62 FR 

54509, October 20, 1997). The SPCC rule defines oil as “oil of any kind or in any form, including, but 

not limited to: fats, oils, or greases of animal, fish, or marine mammal origin; vegetable oils, including 

oils from seeds, nuts, fruits, or kernels; and, other oils and greases, including petroleum, fuel oil, sludge, 

synthetic oils, mineral oils, oil refuse, or oil mixed with wastes other than dredged spoil.” (40 CFR 

112.2) The rule further defines non-petroleum oil as “oil of any kind that is not petroleum-based, 

including, but not limited to: Fats, oils, and greases of animal, fish, or marine mammal origin; and 

vegetable oils, including oils from seeds, nuts, fruits, and kernels.” Both definitions qualify the listed 

examples with the statement “including but not limited to” which indicates that these definitions are not 

limited by the examples provided. 

EPA disagrees with the comment that edible fats and oils pose minimal environmental risks. In a 

notice published on October 20, 1997 (62 FR 54508), EPA denied a request submitted by various trade 

associations to treat facilities that handle, store, or transport animal fats and vegetable oils in a manner 

differently from those facilities that store petroleum-based oils. The petitioners claimed that unlike most 

if not all other oils, animal fats and vegetable oils are non-toxic, readily biodegradable, not persistent in 

the environment, and in fact are essential components of human and wildlife diets. EPA agrees with the 

comment that animal fats and vegetable oils, which are consumed in small amounts, are an essential 

component of human and wildlife diets. However, large amounts of such oils, when discharged into 
18

navigable waters or adjoining shorelines, present significant risks to the environment, including wildlife. 

In fact, the environmental effects of petroleum and non-petroleum oils, including vegetable oils and 

animal fats, are similar because of the physical and chemical properties common to both. (See Federal 

Register notice at 62 FR 54508; October 20, 1997 for more information on the environmental effects of 

oil spills of edible fats and oils.)

EPA acknowledges that the U.S. Coast Guard list of petroleum and non-petroleum oils6does not 

specifically list milk or milk products; however, this does not provide an adequate basis to exempt milk 

or milk products from the SPCC rule, especially since they meet the definition of oil under the SPCC 

rule. Moreover, the U.S. Coast Guard list only includes examples of oils and is not meant to be allinclusive. The examples are organized alphabetically into several subgroups, including a group for 

edible animal and vegetable oils and other oils of animal or vegetable origin (which have historically 

been considered Clean Water Act (CWA) oils). While milk and milk products are not specifically 

included on the Coast Guard list, for purposes of SPCC, they fall under the category of edible animal 

and vegetable oils.

Finally, the Agency did not propose changes to the definitions of oil or oil mixture and therefore 

defining oil and/or oil mixtures are issues outside the scope of this action. Furthermore, EPA will 

continue to enforce the Oil Pollution Prevention regulations for oil mixtures. The owner or operator of a 

SPCC-subject facility should consider the definition of oil included in §112.2 of the rule and the CWA 

definition of oil when making determinations on how to address the SPCC requirements. 

4. Universe Affected by this Action

The approach in this action addresses the concerns raised by the dairy industry for milk 

producers (dairies) and milk product facilities subject to the SPCC requirements. In 2009, the National 

 

6

The U.S. Coast Guard List Of Petroleum and Non-petroleum Oils can be found at: 

http://homeport.uscg.mil/mycg/portal/ep/contentView.do?contentTypeId=2&channelId=-

30565&contentId=120944&programId=117833&programPage=%2Fep%2Fprogram%2Feditorial.jsp&pageTypeId=13489
19

Agricultural Statistics Service (NASS), an agency within the USDA, estimated there were 65,000 

operations with one or more milk cows and 1,178 facilities manufacturing one or more dairy products 

(excluding fluid milk products) in the United States. Most of the 65,000 operations with milk cows 

produce only fluid milk (subject to the PMO or the USDA Recommended Requirements) and their milk 

storage containers would be exempted. Manufactured dairy facilities handle milk and milk products 

subject to standards such as either the PMO or the USDA Recommended Requirements, and all their 

milk/milk product storage containers are also exempt. Milk or milk product containers not under the 

PMO or the USDA Recommended Requirements are generally covered by an equivalent State dairy

regulation; all these state regulated milk and milk product containers are also exempt. This action 

exempts the entire universe of milk and milk product containers, and associated piping and 

appurtenances.

Note that milk and milk product facilities may handle other oils subject to the SPCC 

requirements. These facilities either have or are developing SPCC Plans in anticipation of the 

compliance date, but will not have to account for, or address the exempted containers in their SPCC 

Plans. Some of these facilities may now be either exempt, or eligible as a qualified facility to selfcertify the facility’s SPCC Plan. In addition, “micro” processor facilities that process one milk product 

are expected to manufacture and/or store quantities below the SPCC applicability thresholds for 

container or aggregate quantities (e.g., 1,000 pounds of cheese per month; self-bottling milk for farm 

consumption). The container sizes at these facilities are typically below the 55-gallon de minimis

container size of the SPCC rule and therefore, are unlikely to be subject to SPCC requirements (see 

SPCC Guidance for Regional Inspectors for more information). 

B. Removal of Compliance Date for Exempted Containers, Associated Piping and Appurtenances 

On October14, 2010, the Agency delayed the compliance date by which facilities must address 
20

milk and milk product containers, associated piping and appurtenances that are constructed according to 

the current applicable 3-A Sanitary Standards, and subject to the current applicable Grade “A” PMO or a 

State dairy regulatory requirement equivalent to the current applicable PMO (see 75 FR 63093). The 

date by which the owner or operator of a facility must comply with the SPCC requirements for these 

milk and milk product containers was delayed one year from the effective date of a final rule specifically

addressing these milk and milk product containers, associated piping and appurtenances, or as specified 

by a rule that otherwise establishes a compliance date for these facilities. This delay of the compliance 

date was to provide time for certain facilities to undertake the actions necessary to prepare or amend 

their SPCC Plans, as well as implement them. Today’s action specifically addresses those milk and milk 

product containers, associated piping and appurtenances for which the delay was established and does so 

by exempting them from any SPCC regulatory requirements. Thus, a date for the exempted containers 

to come into compliance with SPCC requirements is no longer necessary. As such, the Agency is 

removing the regulatory requirement to comply with SPCC for these exempt containers by a date 

certain. The Agency provided notice of its intent in the October 14, 2010 final rule. The regulatory text 

is amended by removing and reserving 112.3(c).

This action does not affect the owner or operator’s responsibility to prevent oil discharges, 

including those of milk or milk products, into navigable waters or adjoining shorelines. These 

discharges may be subject to other applicable statutes and regulations, including but not limited to 

Section 311 of the Clean Water Act, 33 U.S.C. 1321. 

VI. Statutory and Executive Order Reviews

A. Executive Orders 12866 and 13563: Regulatory Planning and Review 

Under section 3(f)(1) of Executive Order (EO) 12866 (58 FR 51735, October 4, 1993) and 

Executive Order 13563 (76 FR 3821, January 18, 2011), this action is an “economically significant 
21

regulatory action” because it is likely to have an annual effect on the economy of $100 million or more. 

Accordingly, EPA submitted this action to the Office of Management and Budget (OMB) for review 

under EOs 12866 and 13563 and any changes made in response to OMB recommendations have been 

documented in the docket for this action.

In addition, EPA prepared an analysis of the potential costs and benefits associated with this 

action. This analysis is contained in “Regulatory Impact Analysis for the Final Amendment to the Oil 

Pollution Prevention Regulations to Exempt Certain Milk and Milk Product Containers and Associated 

Piping and Appurtenances (40 CFR PART 112).” A copy of the analysis is available in the docket for 

this action and the analysis is briefly summarized in section VI-C.

B. Paperwork Reduction Act 

This action does not impose any new information collection burden. The final rule amendment 

exempts from the SPCC rule milk and milk product containers, associated piping and appurtenances. 

The Office of Management and Budget (OMB) has previously approved the information collection 

requirements contained in the existing regulations, 40 CFR part 112, under the provisions of the 

Paperwork Reduction Act, 44 U.S.C. 3501 et seq. Burden is defined at 5 CFR 1320.3(b).

An 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. The OMB control numbers for 

EPA’s regulations in 40 CFR are listed in 40 CFR part 9. 

C. Regulatory Flexibility Act

The Regulatory Flexibility Act 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 rule will not have a significant 

economic impact on a substantial number of small entities. Small entities include small businesses, small 
22

organizations, and small governmental jurisdictions. 

For purposes of assessing the impacts of this final rule on small entities, a small entity is defined 

as: (1) a small business as defined in the U.S. Small Business Administration (SBA)’s regulations at 13 

CFR 121.201—SBA defines small businesses by category of business using North American Industry

Classification System (NAICS) codes, and in the case of dairy farms, which constitute a large 

percentage of the facilities affected by this final rule, defines small businesses as having less than $0.75 

million per year in sales receipts; (2) a small 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 that is independently owned and operated and is not 

dominant in its field.

After considering the economic impacts of this final rule on small entities, the Agency certifies 

that this action will not have a significant economic impact on a substantial number of small entities 

since the rule relieves regulatory burden, or otherwise has a positive economic effect on all of the small 

entities subject to the rule. The impact of concern is any significant, adverse economic impact on small 

entities, since the primary purpose of the regulatory flexibility analyses is to identify and address 

regulatory alternatives “which minimize any significant economic impact of the...rule on small entities” 

(5 U.S.C. 603 and 604). 

Under this final rule, EPA is exempting from SPCC rule requirements milk and milk product 

containers, associated piping and appurtenances because they are generally designed, constructed and 

maintained according to the standards such as the current applicable 3-A Sanitary Standards, and are 

subject to the standards such as the current applicable Grade “A” PMO, USDA Recommended 

Requirements for Milk for Manufacturing Purposes and its Production and Processing, or an equivalent 

state dairy regulatory requirement. Overall, EPA estimates that this final action will reduce annual 
23

compliance costs by approximately $146 million for owners and operators of affected facilities. Total 

costs were annualized over a 10-year period using a 7 percent discount rate. To derive this savings 

estimate, EPA first estimated the number of dairy farms and milk processing facilities that will be 

affected each year (2010-2019) by the final rule. EPA next analyzed the expected milk and fuel oil 

storage capacity of dairy farms with varying numbers of cattle based on daily production rate per cow, 

the storage requirements for milk, and conversations with industry representatives. EPA also estimated 

the milk/milk product and fuel oil storage capacity of milk processing facilities, and estimated the cost 

savings associated with the exemption for milk/milk product storage containers at both dairy farms and 

milk processing facilities. These savings include secondary containment costs, cost savings from 

preparing and maintaining an SPCC Plan for a smaller facility, and, for Qualified Facilities, preparing 

only a Plan Template and saving PE certification costs. A certain number of dairy farms are expected to 

become exempt as a result of the amendments. While the Agency extended the exemption to include 

milk product containers, piping and appurtenances, it does not have data on the number of milk product 

containers at milk product manufacturing facilities to determine the overall cost savings for the 

exemption. Therefore, EPA expects that the total cost savings for the final rule is underestimated.

EPA, therefore, concludes that this final rule will relieve regulatory burden for small entities and 

certifies that this action will not have a significant economic impact on a substantial number of small 

entities. EPA requested comment on potential impacts on small entities, but received no comments 

specific to small entities.

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 
24

sector; therefore, this action is not subject to the requirements of sections 202 or 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; the amendments impose no 

enforceable duty on any small government.

E. Executive Order 13132: Federalism 

Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), requires EPA to 

develop an accountable process to ensure “meaningful and timely input by State and local officials in the 

development of regulatory policies that have federalism implications.” “Policies that have federalism 

implications” is defined in the Executive Order to include regulations that 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.”

This final rule 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. Under the Clean Water Act (CWA) section 311(o), States may impose additional requirements, 

including more stringent requirements, relating to the prevention of oil discharges to navigable waters or 

adjoining shorelines. EPA recognizes that some States have more stringent requirements (56 FR 54612, 

October 22, 1991). This final rule would not preempt State law or regulations. Thus, Executive Order 

13132 does not apply to this final rule.

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). This final rule will not significantly or uniquely affect communities of 

Indian tribal governments. Thus, Executive Order 13175 does not apply to this final rule. EPA 
25

specifically solicited additional comment on this action from tribal officials, but none was received.

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

Risks

EPA interprets Executive Order 13045 as applying only to those regulatory actions that are based 

on health or safety risks, such that the analysis required under section 5-501 of the Order has the 

potential to influence the regulation. This final rule is not subject to Executive Order 13045 because it 

does not establish an environmental standard intended to mitigate health or safety risks.

H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy 

Supply, Distribution, or Use

This action is not a “significant energy action” as defined in Executive Order 13211 (66 FR 

18355 (May 22, 2001)), because it is not likely to have a significant adverse effect on the supply, 

distribution, or use of energy. The overall effect of the final rule is to decrease the regulatory burden on 

certain facility owners or operators subject to its provisions.

I. National Technology Transfer and Advancement Act 

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (“NTTAA”), 

Public Law No. 104-113 (15 U.S.C. 272 note) directs 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. NTTAA directs EPA to provide Congress, through OMB, explanations when the 

Agency decides not to use available and applicable voluntary consensus standards. 

The owner or operator of a facility subject to the SPCC rule has the flexibility to consider 

applicable industry standards in the development of an SPCC Plan, in accordance with good engineering 
26

practice. EPA solicited comments on this aspect of the rulemaking and, specifically, invited the public 

to identify potentially applicable voluntary consensus standards and to explain why such standards 

should be used in this regulation. The single comment submitted agreed with the use of the 3-A 

Sanitary Standards and the PMO model code as a basis for exempting milk and milk product containers, 

associated piping and appurtenances from the SPCC requirements. However, this rulemaking does not 

involve technical standards, as it does not set or incorporate by reference any one specific technical 

standard. Therefore, the NTTAA does not apply.

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. 

EPA has determined that this final rule will not have disproportionately high and adverse human 

health or environmental effects on minority or low-income populations because it does not affect the 

level of protection provided to human health or the environment. 

K. Congressional Review Act

The Congressional Review Act, 5 U.S.C 801 et seq., as added by the Small Business Regulatory

Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency

promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the 

Congress and to the Comptroller General of the United States. EPA will submit a report containing this 
27

rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the 

Comptroller General of the United States prior to publication of the rule in the Federal Register. A 

Major rule cannot take effect until 60 days after it is published in the Federal Register. This action is a 

“major rule” as defined by 5 U.S.C. 904(2). This rule will be effective [INSERT DATE 60 DAYS 

FROM PUBLICATION IN THE FEDERAL REGISTER].

List of Subjects in 40 CFR Part 112

Environmental protection, Animal fats and vegetable oils, Farms, Milk, Milk products, Oil 

pollution, Tanks, Water pollution control, Water resources. 

Dated: ____________________________

____________________________

Lisa P. Jackson, 

Administrator.

For the reasons stated in the preamble, the Environmental Protection Agency amends 40 CFR part 112 

as follows: 

PART 112 – OIL POLLUTION PREVENTION

1. The authority citation for part 112 continues to read as follows: 

Authority: 33 U.S.C. 1251 et seq.; 33 U.S.C. 2720; and E.O. 12777 (October 18, 1991), 3 CFR, 1991 

Comp., p. 351.

Subpart A - [Amended]

2. Amend §112.1 by adding paragraphs (d)(2)(ii)(F) and (d)(12); to read as follows:
28

§112.1 General applicability.

* * * * *

(d) * * *

(2) * * *

 (ii) * * *

 (F) The capacity of any milk and milk product container and associated piping and 

appurtenances. 

* * * * *

(12) Any milk and milk product container and associated piping and appurtenances. 

* * * * *

3. Amend §112.3 by removing and reserving paragraph (c)

* * * * *