                        COMMENT AND RESPONSE DOCUMENT 
 
        Oil Pollution Prevention; SPCC Plan Requirements  -  Amendments

                                40 CFR Part 112
                                April 12, 2011
                     U.S. Environmental Protection Agency
                        Office of Emergency Management

                                       
 INTRODUCTION
Purpose of This Document
The purpose of this document is to provide complete responses to comments on the 2009 proposed rule (40 CFR part 112) to revise the Oil Pollution Prevention and Response rule, also known as the Spill Prevention, Control, and Countermeasure (SPCC) rule (40 CFR part 112), promulgated under the Federal Water Pollution Control  Act (FWPCA) or Clean Water Act (CWA).  
 Organization of This Comment and Response Document
To develop this document, EPA reviewed the submissions made to public docket number EPA-HQ-OPA-2008-0821. EPA organized the submission comments based on the topics they addressed in the proposed rule, which had been published in the Federal Register on January 15, 2009 (74 FR 2461). Comments submitted to the public docket for this rulemaking appear in their entirety at http://www.regulations.gov, identified by Docket number "EPA-HQ-OPA-2008-0821."
EPA organized the comments into general categories and subcategories, and responds to each in turn. Several comment excerpts are provided, in addition to responses for each major issue.  In most cases, comment excerpts that simply state support for the proposed revisions are not included. Instead, the Docket Number of the submission is listed in parentheses in the Comments section for each category addressed. The Docket Number was assigned to each submission by the Federal Docket Management System (FDMS) based on the date the submission was received.
The comment excerpts that are included in this document are taken verbatim from the submissions received by the Federal Docket Management System. Comments that make similar statements are grouped and one response is provided for the group. EPA responds to the remaining comments individually.
The following table lists the single comment received by the Federal Docket Management System for docket EPA-HQ-OPA-2008-0821. The Document Number, assigned by FDMS, begins with 002 because 001 is assigned to the Federal Register Notice, which was included in the docket prior to the docket posting the first public comment. The table also lists the name and the organization that submitted the comment. This comment also contains several documents presented in an Appendix. While some of these appendices address issues pertinent to this action, comments that fall outside the scope of this action are not addressed in the responses. The relevant portions of these documents are addressed as comments incorporated by reference in Comment 002. 
                                    FDMS ID
                                  First Name
                                   Last Name
                                 Organization
                                      002
Clay
Detlefsen
International Dairy Foods Association
                              I. Milk Containers
Issue: EPA proposed to amend the Spill Prevention, Control, and Countermeasure (SPCC) rule 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 state dairy regulatory requirement equivalent to the current applicable PMO. 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.
COMMENTS
Support Proposal
Full Support. There was only one comment and the organization "wholeheartedly" supported the concept of the exemption. The comment concurred that the applicable 3-A Sanitary Standards and PMO sanitation requirements did prevent discharges (002).
Alternative Approaches
Extend exemption to all milk and milk products. The comment identifies milk products as products including, but not limited to, cheese, cream, yogurt and ice cream mix. The comment stated that these products and the containers, associated piping and appurtenances in which they are made or stored, do not present a requisite risk or potential of spilling 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 further mentioned that with the exception of some containers for 640-pound blocks of cheese, all dairy processing equipment, storage containers, piping and appurtenances are made of high grade stainless steel and are designed and constructed in accordance with 3-A and/or FDA's Current Good Manufacturing Practices (CGMP) or equivalents. In addition to company inspections, federal and state inspectors enforcing the PMO and acting under other authorities, frequently inspect dairy operations for defects in equipment thereby making spillage and leakage highly improbable. The rigorous cleaning and frequent inspections of such equipment should weigh heavily against the inclusion of milk and milk products within the scope of SPCC. Additional information was submitted along with the comment, including "About 3-A and the 3-A Sanitary Standards and Accepted Practices"; 21 CFR Part 110, Current Good Manufacturing Practice in Manufacturing, Packaging, or Holding Human Food; "Food Good Manufacturing Practice Modernization -- A Focus on Food Safety," November 2, 2005; and Michigan Department of Agricultural Food & Dairy Annual Report, 2002, to provide information to EPA and in support of these statements.  Additionally, a letter from the Food Industry Environmental Council (FIEC, 2004), submitted as part of the appendix to comment 002 indicated that, along with high sanitation standards for edible fats and oils, OSHA regulations for worker safety address storage and use of oils at food facilities, thereby reducing the likelihood of an accidental spill and should an accident occur, the rate and magnitude of release would be low as well (002). 
Exempt large cheese containers from being included in the SPCC plan. According to the comment considerable amounts of cheese are made and stored in larger containers such as 640-pound blocks and these containers should not be included in the SPCC plan. They state (and append additional statements from the NPCA [2008] and FEIC [2006]) that mixtures that are solid at room temperature should be exempted. NPCA (2008) also requests exemption of substances not listed on the U.S. Coast Guard list of petroleum and non-petroleum oils (e.g., no milk or milk product, including cheese, is listed). Additionally, in response to EPA officials' previous inquiry about the fate of cheese should a cheese production or storage facility catch fire, the comment reiterated an assurance that "under no circumstances would cheese liquefy and flow" out of the facility to potentially pollute or endanger navigable waters of the United States (002).
Expand the regulatory oversight that qualifies an exemption. The comment requests that the EPA exemption should 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." The comment indicates that PMO inspections are frequent and would detect any defects of concern. Additionally, dairies not subject to PMOs are also frequently inspected. Furthermore, FDA requires non-corrosive construction materials and frequent cleanings and inspections. All of the requirements for milk and milk products concerning the design, construction, cleaning and inspection process negates and eliminates the risk that dairy equipment will leak or spill, let alone reach navigable waters of the United States. The comment included FDA's rule 21 CFR 110, the Michigan Annual Report, and the reports on the 3-A Sanitary Standards and Good Manufacturing Practice to support these statements (002).
Do not define any milk or milk products as oil. The comment suggested that milk and milk products should be exempt because these products are not oil and cannot be legitimately construed as oil under the SPCC rule. A letter from the same organization that submitted the comment (appended) also stated 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) oil or grease mixed with waste. Furthermore, an appended letter (FEIC, 2004) mentioned minimal environmental risks resulting from edible fats and oils. Another appended letter (National Paint & Coatings Association [NPCA, 2008]) stated that EPA should exempt substances not listed on the U.S. Coast Guard list of petroleum and non-petroleum oils (e.g., no milk or milk product is listed) (002).
Clarify the ambiguous description of "oil."  The commenter expressed concern about the wrongful potential inclusion of milk and milk products within the scope of the SPCC rule given the arguably ambiguous language and interpretations that are used under the rule to determine if a product is oil. The commenter further stated that in every instance where fluid milk was raised as possibly being included or otherwise subject to the SPCC rule, EPA officials assured them that fluid milk would not be subject to the rule. They also incorporate a previous letter (2007) from the commenter indicating that EPA had indicated to them that fluid milk at 3.6 percent fat is not "oil" and butter at 80 percent fat is "oil," but in between, the commenter believed there is no clear definition. The letter further indicated that EPA should end the ambiguity and allow the dairy industry to focus on fuel oils or vegetable oils, when present. They append a comment by NPCA (2008) who requested exemptions for substances not listed on the U.S. Coast Guard list of petroleum and non-petroleum oils [no milk or milk product is listed] (002).
Clarify the mixture rule to exempt dairy products with lower amounts of fat or that are solid at room temperature. The comment states that EPA needs to clarify the mixture rule and the boundaries of the mixture rule concept. They state that IDFA and other food industry organizations (e.g., the appended 2006 and 2007 letters from FEIC and NMPC [2008]) have frequently proposed sensible fixes for EPA to consider, such as exempting liquid mixtures containing less than 50% oil and mixtures that are solid at room temperatures. These same letters have requested guidance on applicability of the mixture rule to dairy products (FEIC, 2006) or have requested EPA to exempt products containing various animal fats (NPCA 2008), further stating that the regulation for mixtures is unclear, and this lack of clarity is exemplified by milk products containing small amounts of animal fats, as even skim milk contains some fats (002). 
Request EPA not initiate enforcement actions while substantial doubt exists about the mixture rule. The comment requests that unless the scope of the SPCC rule is clearly understandable and understood, the concept of due process, and the doctrines of void for vagueness and fair notice demand that 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 and therefore trigger rule compliance (002).
RESPONSE
Extend exemption to all milk and milk products.
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 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.  As stated in the 2008 final rule that previously amended the SPCC rule, additional criteria are required in conjunction with 21 CFR 110 to achieve equivalency with the SPCC requirements for integrity testing. 
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 generally constructed according to current applicable 3-A Sanitary Standards, and are typically subject to 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.  EPA believes that these dairy specific standards 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 has drafted the scope of the exemption to include the entire milk and milk products universe.

Exempt large cheese containers from being included in the SPCC Plan. 
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 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.
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).  
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 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 regulatory oversight that qualifies an exemption. 
EPA agrees that the scope of the exemption should apply to all milk and milk product containers because they are typically subject to a combination of 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 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 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, 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 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. Compliance with PMO or USDA requirements may suffice to meet the broader set of requirements that apply to all food under the FDA requirements. In developing an alternative approach to integrity testing of animal fat and vegetable oil containers, EPA required tanks be subject to the FDA requirements for construction and maintenance of containers, foundations, and support structures along with additional requirements for tank construction materials, insulation, elevation and shop-fabrication (see 73 FR 74266, December 5, 2008; and 74 FR 58791, November 13, 2009). However, EPA believes there are important distinctions between the requirements for milk and milk products in the PMO model code or the USDA Recommended Requirements, and the FDA requirements for all oils intended for human consumption.  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 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. In contrast, 21 CFR part 110 requirements do not specify provisions for inspections and monitoring of containers and do not require operating permits or licenses.
Do not define any milk or milk products as oil.
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 non-petroleum 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 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 oils does 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 all-inclusive. 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.
Clarify the ambiguous description of "oil."  
EPA is not amending the definition of oil in this notice because it is outside the scope of this action. 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. 
Clarify the mixture rule to exempt dairy products with lower amounts of fat or that are solid at room temperature.
EPA is not defining an oil mixture in this notice because it is outside the scope of this action. 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.). 
Request EPA not initiate enforcement actions while substantial doubt exists about the mixture rule.
EPA disagrees that enforcement actions should be postponed for facilities that have questions on the applicability of the Oil Pollution Prevention requirements 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 FWPCA (or CWA) when making determinations on how to address the SPCC requirements. 
