[Federal Register Volume 80, Number 103 (Friday, May 29, 2015)]
[Notices]
[Pages 30686-30688]
[FR Doc No: 2015-12957]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0500]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Requirements on
Content and Format of Labeling for Human Prescription Drug and
Biological Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the

Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by June
29, 2015.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0572.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Requirements on Content and Format of Labeling for Human Prescription
Drug and Biological Products

OMB Control Number 0910-0572--Extension

    FDA's regulations governing the format and content of labeling for
human prescription drug and biological products were revised in the
Federal Register of January 24, 2006 (71 FR 3922), to require that the
labeling of new and recently approved products contain highlights of
prescribing information, a table of contents for prescribing
information, reordering of certain sections, minor content changes, and
minimum graphical requirements. These revisions were intended to make
it easier for health care practitioners to access, read, and use
information in prescription drug labeling; to enhance the safe and
effective use of prescription drug products; and to reduce the number
of adverse reactions resulting from medication errors due to
misunderstood or incorrectly applied drug information.
    Currently, Sec.  201.56 (21 CFR 201.56) requires that prescription
drug labeling contain certain information in the format specified in
either Sec.  201.57 (21 CFR 201.57) or Sec.  201.80 (21 CFR 201.80),
depending on when the drug was approved for marketing. Section
201.56(a) sets forth general labeling requirements applicable to all
prescription drugs. Section 201.56(b) specifies the categories of new
and more recently approved prescription drugs subject to the revised
content and format requirements in Sec. Sec.  201.56(d) and 201.57.
Section 201.56(c) sets forth the schedule for implementing these
revised content and format requirements. Section 201.56(e) specifies
the sections and subsections, required and optional, for the labeling
of older prescription drugs not subject to the revised format and
content requirements.
    Section 201.57(a) requires that prescription drug labeling for new
and more recently approved prescription drug products include
``Highlights of Prescribing Information.'' ``Highlights'' provides a
concise extract of the most important information required under Sec.
201.57(c) (the Full Prescribing Information (FPI)), as well as certain
additional information important to prescribers. Section 201.57(b)
requires a table of contents to prescribing information, entitled
``Full Prescribing Information: Contents,'' consisting of a list of
each heading and subheading along with its identifying number to
facilitate health care practitioners' use of labeling information.
Section 201.57(c) specifies the contents of the FPI. Section 201.57(d)
mandates the minimum specifications for the format of prescription drug
labeling and establishes minimum requirements for key graphic elements
such as bold type, bullet points, type size, and spacing.
    Older drugs not subject to the revised labeling content and format
requirements in Sec.  201.57 are subject to labeling requirements at
Sec.  201.80. Section 201.80(f)(2) requires that within 1 year, any
FDA-approved patient labeling be referenced in the ``Precautions''
section of the labeling of older products and either accompany or be
reprinted immediately following the labeling.
    In the Federal Register of January 21, 2015 (80 FR 2943), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received two comments, however, these
comments did not address the information collection.
    Annual Burden for Prescription Drug Labeling Design, Testing, and
Submitting to FDA for New Drug Applications (NDAs) and Biologics
License Applications (BLAs) (Sec. Sec.  201.56 and 201.57).
    New drug product applicants must: (1) Design and create
prescription drug labeling containing ``Highlights'', ``Contents'', and
FPI; (2) test the designed labeling (e.g., to ensure that the designed
labeling fits into carton-enclosed products); and (3) submit it to FDA
for approval. Based on the projected data used in the January 24, 2006,
final rule, FDA estimates that it takes applicants approximately 3,349
hours to design, test, and submit prescription drug labeling to FDA as
part of an NDA or a BLA under the revised regulations. Currently,
approximately 131 applicants submit approximately 196 new applications
(NDAs and BLAs) to FDA annually, totaling 656,404 hours.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                Number of
                            21 CFR Part                                 Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Labeling Requirements in Sec.  Sec.   201.56 and 201.57............             131              1.5              196            3,349          656,404
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: May 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-12957 Filed 5-28-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: May 12, 2010 (Volume 75, Number 91)]
[Rules and Regulations]
[Page 26645-26646]
[DOCID:fr12my10-2]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 119

[Docket No. 28154; Amendment No. 119-13]
RIN 2120-AG03

Operating Requirements: Domestic, Flag, Supplemental, Commuter,
and On-Demand Operations: Corrections and Editorial Changes

AGENCY: Federal Aviation Administration, DOT.

ACTION: Final rule; technical amendment.

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SUMMARY: The Federal Aviation Administration (FAA) is making minor
technical changes to a final rule published in the Federal Register on
June 14, 1996. That final rule adopted corrections and editorial
changes to several parts, which included an amendment to a section of
part 119 that removed two subparagraphs. However, the FAA inadvertently
did not also amend a separate section of part 119 to remove reference
to the two obsolete subparagraphs. The FAA is issuing this technical
amendment to correct that oversight.

DATES: Effective Date: Effective on May 12, 2010.

FOR FURTHER INFORMATION CONTACT: Alberta Brown, Flight Standards
Service, Air Transportation Division, AFS-200, Federal Aviation
Administration, 800 Independence Avenue, SW., Washington, DC 20591;
telephone<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Federal Aviation Administration (FAA)
published a final rule in the Federal Register on June 14, 1996 (61 FR
30432) \1\ that adopted corrections and editorial changes to 14 CFR
parts 119, 121, and 135. The amendment included one to Sec.  119.21,
which revised then paragraph (a) to remove (a)(3)(i) and (a)(3)(ii).
The FAA should also have amended Sec.  119.49 to remove the two
obsolete subparagraphs referenced in paragraph (b)(11). The FAA is
issuing today's action to correct that oversight.
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    \1\ This 1996 final rule entitled ``Operating Requirements:
Domestic, Flag, Supplemental, Commuter, and On-Demand Operations:
Corrections and Editorial Changes'' was adopted to make corrections
and editorial changes to the ``Commuter Operations and General
Certification and Operations Requirements'' final rule (60 FR 65832;
December 20, 1995).
---------------------------------------------------------------------------

    This action makes the appropriate amendatory change to remove two
obsolete subparagraphs in current Sec.  119.49(b)(11). With this
amendatory change, the reference to subparagraphs Sec.  119.21(a)(3)(i)
and (a)(3)(ii) will be removed from Sec.  119.49(b)(11). This amendment
will not impose any additional restrictions on operators affected by
these regulations.

Technical Amendment

    The technical amendment will remove the reference to Sec.
119.21(a)(3)(i) and (a)(3)(ii) from Sec.  119.49(b)(11).

List of Subjects in 14 CFR Part 119

    Administrative practice and procedure, Air carriers, Aircraft,
Aviation safety, Charter flights, Reporting, and recordkeeping
requirements.

0
Accordingly, Title 14 of the Code of Federal Regulations (CFR) part 119
is corrected by making the following correcting amendment:

PART 119--CERTIFICATION: AIR CARRIERS AND COMMERCIAL OPERATORS

0
1. The authority citation for part 119 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 1153, 40101, 40102, 40103, 40113,
44105, 44106, 44111, 44701-44717, 44722, 44901, 44903, 44904, 44906,
44912, 44914, 44936, 44938, 46103, 46105.

0
2. Amend Sec.  119.49 by revising paragraph (b) to read as set forth
below.

Sec.  119.49  Contents of operations specifications.

* * * * *
    (b) Each certificate holder conducting supplemental operations must
obtain operations specifications containing all of the following:
    (1) The specific location of the certificate holder's principal
base of operations, and, if different, the address that shall serve as
the primary point of

contact for correspondence between the FAA and the certificate holder
and the name and mailing address of the certificate holder's agent for
service.
    (2) Other business names under which the certificate holder may
operate.
    (3) Reference to the economic authority issued by the Department of
Transportation, if required.
    (4) Type of aircraft, registration markings, and serial number of
each aircraft authorized for use.
    (i) Subject to the approval of the Administrator with regard to
form and content, the certificate holder may incorporate by reference
the items listed in paragraph (b)(4) of this section into the
certificate holder's operations specifications by maintaining a current
listing of those items and by referring to the specific list in the
applicable paragraph of the operations specifications.
    (ii) The certificate holder may not conduct any operation using any
aircraft not listed.
    (5) Kinds of operations authorized.
    (6) Authorization and limitations for routes and areas of
operations.
    (7) Special airport authorizations and limitations.
    (8) Time limitations, or standards for determining time
limitations, for overhauling, inspecting, and checking airframes,
engines, propellers, appliances, and emergency equipment.
    (9) Authorization for the method of controlling weight and balance
of aircraft.
    (10) Aircraft wet lease information required by Sec.  119.53(c).
    (11) Any authorization or requirement to conduct supplemental
operations as provided by Sec.  119.21(a)(3).
    (12) Any authorized deviation or exemption from any requirement of
this chapter.
    (13) An authorization permitting, or a prohibition against,
accepting, handling, and transporting materials regulated as hazardous
materials in transport under 49 CFR parts 171 through 180.
    (14) Any other item the Administrator determines is necessary.
* * * * *

    Issued in Washington, DC on May 7, 2010.
Pamela Hamilton-Powell,
Director, Office of Rulemaking, Aviation Safety.
[FR Doc. 2010-11266 Filed 5-11-10; 8:45 am]
BILLING CODE 4910-13-P


                           American Foundry Society
Comments on EPA's Draft FAQs on the Requirements of the Reduction of Lead in Drinking Water Act of 2011

                                 June 21, 2013

The American Foundry Society (AFS) hereby submits the following comments on the United States Environmental Protection Agency (EPA) draft Frequently Asked Questions (FAQs) on the Reduction of Lead in Drinking Water Act of 2011.  On January 4, 2011 Congress passed the "Reduction of Lead in Drinking Water Act of 2011"  that revised the definition of lead-free products from a lead-content of not more than 8 percent to not more than a weighted average of 0.25 percent lead when used with respect to the wetted surfaces of pipes, pipe fittings, plumbing fittings, and fixtures.  The new definition of lead-free products would prohibit the use of pipes and fixtures used for drinking water that have greater than 0.25 percent lead content after January 4, 2014.  The new requirements pose some significant challenges for metalcasting operations, and additional clarification and guidance on how these requirements will be implemented are needed.

EPA recently developed a set of draft FAQs that include the Agency's interpretation of the statutory requirements of the new legislation.  EPA has requested comments on the draft FAQs and additional input from stakeholders that are potentially impacted by the new lead standard.  Provided below is a summary of the technical comments and concerns that AFS has regarding the FAQs and EPA's interpretation of the requirements of the new statutory requirements.  Many of these technical issues will also impact other industry sectors beyond metalcasting and have been presented to EPA by the trade groups representing these industries.

      I. INDUSTRY OVERVIEW

AFS is the major trade and technical association for the North American metalcasting industry.  AFS has more than 7,000 members representing over 2,000 metalcasting firms, their suppliers and customers.  The organization exists to provide knowledge and services that strengthen the metalcasting industry for the ultimate benefit of its customers and society.  AFS seeks to advance the sciences related to the manufacture and utilization of metalcasting through research, education and dissemination of technology.  AFS also provides leadership in government relations, marketing, management and human resources for the metalcasting industry.

The practice of melting and casting metal into solid forms has served society's needs for more than 5,000 years.  Metal castings are the foundation for all other manufacturing, and metalcasters have been a vital building block for every nation's economic wealth.  Every sector relies on castings, 90 percent of all manufactured goods and capital equipment incorporate engineered castings into their makeup.  The major industries supplied by metalcasting include agriculture, construction, mining, railroad, automotive, aerospace, communications, health care, defense and national security.

The American metalcasting industry provides employment for over 200,000 men and women directly and supports thousands of other jobs indirectly.  The industry supports a payroll of more than $8 billion and sales of more than $36 billion annually.  Metalcasting plants are found in every state, and the industry is made up of predominately small businesses.  Approximately 80 percent of domestic metalcasters have fewer than 100 employees.

      II. TECHNICAL COMMENTS ON DRAFT FAQS
EXEMPTIONS FROM NEW DEFINITION OF LEAD-FREE

The legislation does provide exemptions from the new definition of lead-free for certain products, including:

   * "pipes, pipe fittings, plumbing fittings, or fixtures, including backflow preventers, that are used exclusively for non-potable services, such as manufacturing, industrial processing, irrigation, outdoor watering, or any other uses where the water is not anticipated to be used for human consumption" and
   *  "toilets, bidets, urinals, fill valves, flushometer valves, tub fillers, shower valves, service saddles, or water distribution main gate valves that are 2 inches in diameter or larger."

The items specifically included in these two exemptions are not restricted by this legislation on the amount of lead that they may contain.  The scope of these exemptions and how they will be enforced are not, however, entirely clear.  For example, are all component parts of these items exempt from the new lead standard?

In addition, the draft FAQS appear to provide conflicting information on whether items such as plumbing fixtures that are exempt from the new definition of lead-free must still be in compliance with the voluntary standard Section 9 of NSF/ANSI Standard 61.  EPA states that there is no federal requirement for these items to meet the 8 percent lead standard, but that states regulations may require compliance with these voluntary standards.  Such an interpretation creates a confusing and patchwork system of regulatory compliance with the definition of lead-free nationwide making it difficult for metalcasting operations to comply with a single, well-defined lead standard.

      A. EPA Efforts to Implement New Legislation  -  Comprehensive Guidance Is Needed

Similar legislation is already in place in California, but the implementation of the new requirements in the federal legislation poses some significant challenges for many industry sectors, including metalcasting. Although the legislation does not require EPA to promulgate new regulations to enforce the statutory changes, EPA is charged with the implementation of the new requirements.  EPA has indicated that it plans to issue new regulations to implement the requirements as part of the lead and copper drinking water standard, but that it will not have a final regulation in place before the January 4, 2014 deadline.  In addition EPA expects that the revisions to the lead and copper drinking water standard will be delayed even further due to concerns over the replacement of existing service lines.

The implementation of this new legislation can pose some significant burdens for some segments of the metalcasting industry.  Accordingly, EPA held a public meeting on this topic in August 2012 and has been soliciting input from industry, states, local water utilities, and NGOs to provide clarification on the new requirements such as whether a dual inventory of products would be needed, labeling requirements for "lead-free" products, and what type of interim policy guidance may be needed.  In addition, EPA had announced that it expected to issue a guidance document for implementing the new requirements before the end of 2013, just prior to the promulgation of the new rulemaking.

While the FAQs represent a good first step in clarifying the requirements of the new legislation, it is not clear whether EPA still intends to issue a guidance document beyond the FAQs.  AFS requests that EPA consider developing a more comprehensive guidance document that focuses on more issues of concern for manufacturers of products subject to the new requirements.  The FAQs include broader information for users and distributers of plumbing products such as plumbers and retail stores, and they provide limited guidance for those most directly impacted by the new requirements, namely manufacturers.  A more comprehensive guidance document is needed for manufacturers of these products who may be required to retool and reinvest in processes to comply with the new requirements, which could take many months and be extremely expensive.

      B. Minimal Benefits and Burdensome Costs

As the EPA moves to implement the new requirements incorporating the Reduction of Lead in Drinking Water Act of 2011, agency officials need to consider the current Safe Drinking Water Act (SDWA) requirements and how they have been successfully implemented and regulated by States, municipalities, and end users without significant governmental oversight.    Reduction of lead in drinking water has already been achieved through the implementation of national standards such as AWWA and ASTM, user specifications as part of contracts and bid documents, demonstrations of compliance, and industry and trade group oversight.

The new legislation revises the lead content maximum from 8.0 percent to 0.25 percent.  While this is a significant change in the eyes of manufacturers, the same drivers to reduce lead in drinking water in the current SDWA lead level will continue.  It is not clear that the new requirements will reduce lead in drinking water significantly, but they will create unnecessary industry burden and customer confusion from such changes.

The new regulatory requirements will increase manufacturing costs and restrict product availability without providing any significant human health benefits beyond those already afforded by the existing lead drinking water standards.  Products constructed of copper alloy lead-free materials (0.25 percent or less lead) already carry a 25 to 45 percent higher price than the equivalent 5 percent lead-bearing product historically used in waterworks brass products (UNS C83600).  The increased expense is attributed to higher raw material costs, new foundry and machining requirements, and higher processing losses due to the nature of the new lead-free alloys.

States and water utilities have also expressed concerns about the burdens of implementing these requirements, including the loss of existing product inventory, the increased costs associated with using lead-free compliant products, and the likelihood that the changes will discourage water distribution maintenance due to the increased costs of repair and replacement parts.  These factors will continue to negatively impact public and private water sectors, and eventually produce higher water bills for end users.

Promoting public health goals through new regulatory requirements can be sound public policy.  Government officials should, however, strike a balance between the appropriate level of regulation where there is a real benefit, and the compliance costs and regulatory burdens that are imposed on manufacturers associated with the new requirements.  In this case, the current lead drinking water standard is already protective of human health without the need for the additional regulatory requirements imposed by the new legislation.  EPA should, therefore, take steps to minimize the burdens on industry through the implementation of the new requirements.

      C. Lead Content versus Leachate Standard

The legislation sets a new definition of lead-free products based on lead content.  Under federal law this replaces the older definition based on the NSF/ANSI Standard 61 lead leachate for products.  EPA needs to expressly identify the NSF/ANSI Standard 372 as the only appropriate standard in defining lead-free products associated with the drinking water standard.

The NSF/ANSI Standard 372 is a lead content standard that is currently used in reference to state laws in California, Vermont, Maryland and Louisiana.  The NSF/ANSI Standard 61 is NOT a lead-content standard, is not applicable to the state laws, and EPA should specify that it should not be used to determine the definition of lead-free in the new legislation.  Accordingly, the NSF/ANSI Standard 372 lead-content standard should be used exclusively for implementing the new lead content requirements nationwide.  Otherwise, those attempting to comply with the new requirements will be faced with a confusing and patchwork system of regulatory compliance, rather than a single, well-defined national lead standard.

      D. Independent, Third-Party Certification

In the draft FAQs, EPA stated that manufacturers are not required to obtain a third-party certification or create a system to document compliance with self-certification.  AFS agrees that certification should not be required, because an independent, third-party certification for a large manufacturer can easily exceed six figures as an annual reoccurring cost.  Requiring third-party certification would impose unnecessary compliance costs and regulatory burdens on manufacturers without providing any significant health-based improvements.

As noted above, there has been discussion regarding the use of NSF/ANSI Standard 61 or NSF/ANSI Standard 372 as part of the new SDWA requirements to show compliance with the new legislation.  The NSF/ANSI Standard 372 was developed specifically for the California lead-free drinking water law, and consequently would be appropriate for the new federal lead-content standard of 0.25 percent.  The NSF/ANSI Standard 372 is the only existing standard that directly parallels the new law.

Conversely, NSF/ANSI Standard 61 contains requirements well beyond what the new legislation mandates, and as such prohibits product certification for some large devices and assemblies constructed in lead-free alloys.  The NSF/ANSI Standard 61 will not serve as a viable national verification vehicle due to the impact on product availability across a large variety of common waterworks and plumbing products, and its continued use is inconsistent with the requirements of the new legislation.

      E. Transition Period Needed for Existing Inventories

While the language of the new legislation indicates that the requirements are effective January 4, 2014, numerous uncertainties, questions, and challenges remain regarding the implementation of those requirements.  Additional time is necessary to determine which products fall within scope of the new requirements, establish product-by-product classifications, redesign and retool production lines, replace existing stock, and allow for new packaging labeling to distinguish between new lead-free and existing products.  EPA should, therefore, provide a transition period up to 36 months to clarify how the new requirements will be implemented and allow the use of existing inventories of products.

      F. The Issue of Dual Inventories Must Be Addressed

EPA is considering whether it should use a dual-inventory or single-inventory approach to implementing the new legislation.  A dual-inventory approach would require manufacturers to produce separate products used exclusively for non-potable water service and those used for potable water service.  A single-inventory approach would require all products that could potentially be used for potable water meet the new 0.25 percent lead content standard.

Under a single-inventory approach all products from all manufacturers, even though they are not intended for potable water service or that could be interchanged for potable water service, must be made from lead-free materials because at some point they may be used for potable water service.  This approach is neither practical nor realistic given the scope of product types and manufacturing locations worldwide to be considered as a viable option.

Many U.S. metalcasters produce products that are sold around the world, and the same product will be made in no-lead brass for usage in the U.S., and in leaded brass for uses outside the U.S.  Legal requirements that mandate only one alloy and not dual inventories will negatively impact U.S. global competitiveness by significantly increasing development costs for separate designs for U.S. companies.

The same logic is applied to the promotion of unique or non-interchangeable product connections to restrict product use for potable water service only.  This again ignores decades of standardization, manufacturing economies of scale, and worldwide distribution and product equivalency, replacing it with specialty products with higher end user costs and availability issues.  Entire product lines will require redesign with millions of dollars in retooling as well as new standards development on an international scale.  A strict, single-inventory approach would, essentially, negate the exemption for products used for non-potable water service and place the U.S. at a distinct economic disadvantage for the ability to import or export products.

The California law allows for a dual-inventory approach to provide a transition period for existing inventories to be used and new manufacturing processes to be implemented.  EPA should consider allowing (as opposed to mandating) dual inventories with labeling on product packaging depending on the intended use of the product.  While this interim solution may be a bit more difficult to implement and enforce, it could provided a much needed transition period to minimize the burden on manufacturers and end users of the products.

      G. Exemptions Need Further Clarification

The new legislation provides exemptions from the lead-free requirements for specified categories of products that are used exclusively for non-potable water service or not anticipated to be used for potable water service.  To qualify for the exemption, it is not clear whether the product must be physically incapable for use on potable water service, or could be physically capable of use in potable water service, but simply labeled as illegal for use in potable water service.  It is our understanding that EPA is considering the following potential approaches to this issue:

      1) Allow dual product lines (potable and non-potable products that are interchangeable) and label the non-potable version as not for use with potable water, or
      2) Require all products that are interchangeable with a potable counterpart must meet the new lead-free 0.25 percent content limit because it is not used exclusively for non-potable water service, thereby effectively eliminating the exemption for non-potable uses.

Clarification is needed for the exemption for products used for non-potable water service, particularly because as discussed below EPA states that the SDWA does not require manufacturers to label products.  EPA needs to state in plain language that products with hose threads used for outdoor watering, washing machines valves, etc. either do or do not need to comply with the lead-free requirements.  The exemption should do not rely on vague terms like "not anticipated."

Dual inventory in plumbing distribution is confusing without something for the end user to distinguish compliance or non-compliance.  Products that are commonly installed in both potable and non-potable applications and sold through plumbing distribution may be better served to move toward lead-free material for all applications, but care should be given by providing exclusions for products sold exclusively for non-potable applications and distribution networks.

In addition, ball valves, fittings or valves should NOT be lumped together when requiring product to be lead-free.  These products can be used exclusively for many other markets other than potable water or plumbing distribution.  Gas Distribution would be one example where  products consists of high pressure ball valves, plug valves, fittings and meter settings that may have lead in them.  These products are sold exclusively through gas distribution companies.

      A. Marking and Labeling Requirements

In the draft FAQs, EPA states that the SDWA does not require manufacturers to label their products as lead-free.  EPA does, however, encourage manufacturers to provide consumers with information on the lead content in the products.

On this point, it is our understanding that EPA is considering the following options for labeling:

      1) labeling of the package  -  "illegal to use this product for potable water service" (similar to what it has done with lead solder);
      2) labeling of the product  -  require labeling of product with a symbol beyond the packaging because the product could be separated from the package; or
      3) labeling of both package and product.

Each of these options present challenges that EPA must consider for the implementation of this requirement.

Producers of lead-free products have already established physical product marking identities to control products internally for both inventory and scrap control and to differentiate them from lead bearing products currently offered for the potable and non-potable water market.  These identities are applied in a variety of forms from automated marking to cast-in-place dependent upon the thousands of different product designs, manufacturing methods, and equipment.  It must remain the manufacturers' option on physical product marking as far as the descriptive term, method of application, and location.

Most lead-free physical identities currently use the term "NL" or "LF".  The lead-bearing equivalent products approved under the existing drinking water requirements will not exhibit a physical material identification.  After January 4, 2014, those products will only be permitted in non-potable water applications or as exempted by the law.  Unless EPA provides appropriate flexibility implementing the new requirements, only lead-free products bearing the lead-free mark indicating compliance may be permitted in potable water service after January 4, 2014.  Product packaging, labels, or instruction inserts may also carry additional information relative to compliance with the new requirements as recommended by the EPA.

Manufacturers in the metalcasting industry are already providing lead-free compliant products marked with an `NL' or `LF'. This has been standard practice for over ten years.   Our customers have been educated to this methodology and changing it would create confusion in our industry.  It would also be expensive and timely to change these markings on thousands of tools.  Provided below is an example of marking and message that is currently used.

                                     251658240
               A cast "NL" designates this product as no-lead brass.

Physical markings on products may be impractical for certain products because of size, process, or design. Some products simply do not have available real estate for a marking.

Color coding on packaging labels is something easily recognizable potentially for either potable or non-potable applications.  Manufacturers can implement color coding on packaging labels relatively inexpensively.   On the other hand, color coding, painting or dyeing products is prohibitively expensive and would be difficult to implement without an appropriate transition period.

Making products with lead in them physically incapable of being installed in a potable water application is not a cost acceptable alternative.  Pipe threads and other types of connections are common in many industries other than water applications such as gas distribution, irrigation, sewer applications, HVAC, etc.  Expecting all of these industries to change their product design is neither reasonable nor feasible and would cost BILLIONS of dollars!

      A. Calculation of Lead Content

Pursuant to the new legislation lead content must be calculated "for each wetted component" and "the lead content of the material used to produce wetted components shall be used to determine compliance with" the 0.25 percent requirement.  These two phrases in the new legislation appear to take two different approaches in calculating lead content.  EPA needs to clarify what language is controlling.  Is it the lead content of the surface of the product that is exposed to the water or the lead content of the alloy used to produce the wetted component (and not just the surface exposed to the water)?

If EPA is concerned about potential increased lead in drinking water the calculation should be limited only to the surface exposed to the water.  This could allow higher lead levels that may be need to provide the essential functional attributes of lead for the product without increasing the potential exposure to lead on the wetted surface of the product.  Regardless, EPA must provide some specific guidance on the calculation of lead content to ensure consistent implementation and enforcement of the new standard.

      B. Repairing or Replacing Products for Potable Water Service

In the course of maintaining water service equipment, it is necessary to repair the equipment that is in operation prior to January 4, 2014 and install replacement parts in that equipment.  Does the entire equipment have to meet the new lead-free standard or would the new standard only apply to the new replacement part that is installed after the January 4, 2014.  Given that the cost of the equipment can be substantial, companies should not have to forego it capital investment in the equipment and abandon it to meet the new lead-free standard.  The new lead-free requirement should only apply to the replacement part that is installed and not the entire equipment.  EPA should also give consideration to situations in which a lead-free replacement part is not available or not compatible with the existing equipment.

      C. Functional Cost-Effective Substitutes for Lead Have Not Been Identified for All Products

One of the biggest concerns about the new, low-lead content requirement is the availability of functional and cost-effective substitutes for lead in products.  The lead in products provides essential functional characteristics such as malleability and machinability.  Before determining how it should implement these new requirements, EPA must consider the available scientific research on the machinability and other functional attributes of products with 0.25 percent lead content.  In addition, EPA should also consider the available scientific research on machinability and other functional attributes of possible lead substitutes such as bismuth alloys.

While significant progress has been made in developing products that can meet the new definition of lead-free, AFS and its members will continue to develop appropriate products to meet the new definition of lead-free. As discussed above, additional time is needed for the metalcasting industry and other industry sectors to transition the new technology to comply fully with the new requirements.

      I. CONCLUSION
            ON BEHALF OF THE AMERICAN FOUNDRY SOCIETY, WE APPRECIATE THE OPPORTUNITY TO SUBMIT THESE COMMENTS ON the draft FAQs and how EPA should implement the new requirements of the Reduction of Lead on Drinking Water Act of 2011.  If you have any questions or would like additional information on these comments, please contact Jeff Hannapel at<EMAIL_ADDRESS>


[Federal Register: August 28, 2007 (Volume 72, Number 166)]
[Notices]
[Page 49277]
[DOCID:fr28au07-91]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL07-88-000]

Great Lakes Utilities, Indiana Municipal Power Agency, Missouri
Joint Municipal Electric Utility Commission, Missouri River Energy
Services, Prairie Power, Inc., Southern Minnesota Municipal Power
Agency, Wisconsin Public Power, Inc.; Complainants v. Midwest
Independent Transmission System Operator, Inc.; Respondent; Notice of
Complaint

August 21, 2007.
    Take notice that on August 17, 2007, pursuant to Rule 206 of the
Rules and Practice and Procedure, 18 CFR 385.206, and section 206 of
the Federal Power Act, Great Lakes Utilities, Indiana Municipal Power
Agency, Missouri Joint Municipal Electric Utility Commission, Missouri
River Energy Services, Prairie Power, Inc., Southern Minnesota
Municipal Power Agency, Wisconsin Public Power, Inc. (Complainant)
filed a formal complaint against Midwest Independent Transmission
System Operator, Inc. (Respondent) alleging that the Revenue
Sufficiency Guarantee charge allocation provisions of the Respondent's
tariff are unjust, unreasonable and unduly discriminatory, and
therefore must be revised. The Complainants request that the Federal
Energy Regulatory Commission (Commission) establish the earliest
possible refund-effective date with respect to the necessary revisions.
    The Complainants state that copies of the complaint were served on
the contacts for the Respondent as listed on the Commission's Corporate
Officials list.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on September 7, 2007.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-16947 Filed 8-27-07; 8:45 am]

BILLING CODE 6717-01-P