[Federal Register Volume 79, Number 112 (Wednesday, June 11, 2014)]
[Notices]
[Pages 33559-33562]
[FR Doc No: 2014-13584]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0595]

Environmental Protection Agency and Food and Drug Administration
Advice About Eating Fish: Availability of Draft Update

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of docket; request for comments.

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SUMMARY: In March 2004, the Food and Drug Administration (FDA) and the
U.S. Environmental Protection Agency (EPA) (the Agencies) jointly
released a document entitled ``What You Need to Know About Mercury in
Fish and Shellfish'' (the 2004 advice). FDA and EPA are now announcing
a draft update that contains both advice and supplemental questions and
answers for those who want to understand the advice in greater detail.
FDA and EPA are establishing a public docket and seeking public comment
on both the substance of the advice and how best to frame the advice
for consumers so that it is both understandable and influential. In
addition to inviting public comments, the Agencies intend to seek the
input of the FDA Advisory Committee on Risk Communication in a meeting
open to the public. The Agencies may also hold public meetings in
various locations around the country. Information about any such
meetings will be published in the Federal Register once dates and
locations are confirmed.

DATES: The comment period will be open until 30 days after the last
transcript from the advisory committee meeting and the other meetings
mentioned previously becomes available. The date for closure of public
comment will be published in a future notice in the Federal Register.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. FDA will share with EPA all comments submitted to
the FDA docket.

FOR FURTHER INFORMATION CONTACT: FDA: Philip Spiller, Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740-3835,

240-402-1428, email<EMAIL_ADDRESS>EPA: Jeffrey Bigler,
MS-4305T, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., Washington, DC 20460,<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Fish and shellfish (referred to collectively in this notice as
``fish'') provide protein, are low in saturated fat, and are rich in
many micronutrients; they also provide certain omega-3 fatty acids
(Ref. 1). However, as a result of natural processes and human activity,
fish also contain mercury in the form of methylmercury. Methylmercury
can adversely affect the central nervous system, particularly the
developing brain of the fetus.
    FDA issued fish consumption advice relating to mercury in 1994,
followed by separate, but simultaneously issued, FDA and EPA fish
consumption advice in 2001. FDA's 2001 advice addressed commercial
fish; EPA's 2001 advice addressed locally caught fish. In March 2004,
FDA and EPA jointly issued a document entitled ``What You Need to Know
About Mercury in Fish and Shellfish; 2004 EPA and FDA Advice for: Women
Who Might Become Pregnant, Women Who Are Pregnant, Nursing Mothers,
Young Children'' (Ref. 2). The 2004 advice was issued to help
individuals in the target population limit their exposure to mercury
while still obtaining the health benefits of fish consumption. The 2004
advice recommends avoiding four types of commercially available fish
that have the highest average mercury concentrations: Tilefish, shark,
swordfish, and king mackerel. The advice further recommends that women
in the target population eat up to--but not exceed--12 ounces per week
of most other types of commercially available fish. It recommends
limiting consumption of one species, white (albacore) tuna, to no more
than 6 ounces per week. For local fish caught by family and friends,
the advice recommends following locally posted fish advisories
regarding safe catch. Where no such advice exists, it recommends
limiting consumption of locally caught fish to 6 ounces per week and
eating no other fish that week.
    The 2004 advice is no longer entirely consistent with the most
current U.S. Dietary Guidelines for Americans (DGAs), which are issued
jointly every 5 years by HHS and USDA. HHS and USDA recommend in the
Dietary Guidelines for Americans 2010 that ``women who are pregnant or
breastfeeding consume at least 8 and up to 12 ounces per week of a
variety of seafood per week, from choices lower in methyl mercury''
taking into account evidence relating fish consumption to improved
infant health and developmental outcomes \1\ (Refs. 3 and 4). While the
2004 advice encourages fish consumption as part of a healthy diet, it
does not encourage consumption of any particular amount of fish in
order to improve health and developmental outcomes. As an additional
matter, quantitative assessments recently performed have produced
results that support the quantitative recommendations in the 2010 DGAs.
These assessments estimate risks and benefits to neurodevelopment from
fish consumption during pregnancy. They estimate ``net effects'' from
eating fish during pregnancy by estimating both adverse effects from
mercury and beneficial effects from nutrients in fish. These
assessments include a 2011 report by the Food and Agriculture
Organization of the United Nations (FAO) and the World Health
Organization (WHO) entitled ``Report of the Joint FAO/WHO Expert
Consultation on the Risks and Benefits of Fish Consumption'' (Ref. 5)
and a 2014 assessment conducted by FDA entitled, ``A Quantitative
Assessment of the Net Effects on Fetal Neurodevelopment from Eating
Commercial Fish (As Measured by IQ and also by Early Age Verbal
Development in Children)'' (Ref. 6). The FDA assessment was first
published in draft in 2009 and then recently revised to incorporate
comments and advice from peer reviewers, the public, and other Federal
Agencies, including recent comments from EPA. In addition, since 2004
there have been other publications in the peer reviewed scientific
literature evaluating the benefits of fish consumption versus risks of
mercury exposure (Refs. 7 and 8).
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    \1\ A review of the evidence taken into account in the
development of the fish consumption recommendation in the Dietary
Guidelines for Americans 2010 can be found on pages 239-241 in the
``Report of the Dietary Guidelines Advisory Committee on the Dietary
Guidelines for Americans,'' 2010, at http://www.cnpp.usda.gov/DGAs2010-DGACReport.htm.
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II. What is being proposed in the draft updated advice?

    FDA and EPA are now proposing to update their 2004 advice to make
it consistent with the recommendations in the Dietary Guidelines for
Americans 2010. It is important that advice on fish consumption be
harmonized across Federal Agencies. Inconsistent advice can cause
confusion and undermine the public health objectives that the advice is
intended to accomplish. The Agencies are also proposing to modify the
wording and organization of the 2004 advice in order to enhance the
likelihood that it will be followed by the target audience. Consuming 8
to12 ounces of fish per week while pregnant or breastfeeding would be a
significant dietary change for most women. In a survey of over 1,200
pregnant women conducted by FDA in 2005, median fish consumption was
1.8 ounces per week (Ref. 9).
    Consistent with the Dietary Guidelines for Americans 2010, the
draft updated advice would:
     Recommend that pregnant women, women who might become
pregnant, and breastfeeding mothers eat at least 8 and up to 12 ounces
per week of a variety of fish lower in mercury within their calorie
needs. The draft updated advice also describes this amount as 2 or 3
servings per week. The 2004 advice translated 12 ounces into 2 servings
based on an assumption that a single serving is likely to be around 6
ounces; however, there is variability surrounding serving sizes and
single servings can often be somewhat smaller than 6 ounces (Refs. 10,
11, and 12). The proposed consumption target of 8 to 12 ounces per week
of fish lower in mercury is designed to maximize the potential health
and developmental benefits that fish could provide. The recommendation
to stay within calorie needs is aimed at insuring that women who eat
more fish in order to achieve 8 to 12 ounces of fish per week do not
inadvertently exceed the number of calories that are appropriate for
them when they do so.
     Continue to recommend that the target audience avoid
certain fish with the highest mercury concentrations; those fish are
tilefish, shark, swordfish, and king mackerel. It would recommend
avoidance of tilefish only from the Gulf of Mexico, however. Data on
tilefish from the Atlantic Ocean indicate that these fish have much
lower levels of mercury on average (Ref. 13).
     Advise members of the target audience that they may eat
tuna but continue to recommend limiting white (albacore) tuna to 6
ounces per week.
     Retain the recommendations included in the 2004 advice for
fish caught in local streams, rivers, and lakes. There are local waters
where there may have been little or no monitoring and, therefore, the
extent of potential mercury contamination is unknown. Fish in local
waters can contain higher levels of mercury than commercially available
species. Local freshwater fish may also differ in their nutritional
composition.

     Continue to extend the recommendations in the 2004 advice
to young children because their nervous systems are still developing.
The Dietary Guidelines for Americans 2010 do not provide specific
feeding recommendations for infants and young children under the age of
2 years, but they do note that the nutritional value of fish is of
particular importance in early infancy from maternal consumption and in
childhood (Ref. 3). The draft updated advice would continue to
recommend that the portions for children be smaller than those for
adult women and the accompanying questions and answers (Q & A) would
provide advice on specific consumption amounts for fish in general and
for albacore tuna.
     Note that fish provides health benefits for the general
public. This information is intended for the general public, not just
for the target audience. The Dietary Guidelines for Americans 2010
recommend that the general public increase the amount and variety of
fish consumed.

III. What else are FDA and EPA seeking comment on?

    In addition to requesting comments on the substance of the draft
updated advice, FDA and EPA are seeking public comment on alternative
risk communication approaches for conveying the message and its
supplemental Q & A. The Agencies recognize that how the message is
conveyed can be highly important to its success. The approach in this
draft update seeks to balance simplicity of message with specificity of
information. FDA and EPA believe that public input is required to
assist in achieving this balance. FDA and EPA anticipate the public
process will address how best to provide accurate, balanced
descriptions of the purpose for the updated advice and the potential
benefits and risks of fish consumption.
    FDA and EPA further anticipate that the public process will address
whether the questions in the draft supplemental Q & A are appropriate
and represent those most likely to be asked by consumers, and whether
the answers are accurate and sufficiently informative to encourage more
consumption of fish and to guide consumers to fish lower in mercury.
    On a specific matter, the Agencies are interested in public comment
on whether to add two additional fish to the list of fish that members
of the target audience should not eat. Because the draft updated advice
tracks the Dietary Guidelines for Americans 2010, the draft updated
advice recommends essentially \2\ the same fish to avoid as is
recommended in the DGAs. They are: (1) Tilefish from the Gulf of Mexico
(average of 1.45 parts per million (ppm) of mercury); (2) swordfish
(average of 1.00 ppm of mercury); (3) shark (average of 0.98 ppm of
mercury); and (4) king mackerel (average of 0.73 ppm of mercury). The
average mercury concentrations in these fish are notably higher than
the concentrations in all other commercial species. FDA and EPA are
seeking comment on whether to add orange roughy and marlin to the list
of fish to avoid. While orange roughy and marlin are lower in mercury
than the four fish listed previously (orange roughy averages 0.57 ppm
mercury, which equals 80 micrograms/4 ounce (oz.) of cooked fish, and
marlin averages 0.49 ppm mercury, which equals 69 micrograms/4 oz. of
cooked fish), their mercury concentrations are higher than nearly all
other commercial fish. Moreover, both orange roughy and marlin can be
unusually low in omega-3 fatty acids. Omega-3 fatty acids may
contribute to the healthful effects from fish, although the supporting
science is not settled on this point. For those reasons, we
particularly invite comment on whether it would be prudent for pregnant
women or those who might become pregnant, breastfeeding women, and
young children, to avoid orange roughy and marlin in addition to the
four other fish to avoid.
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    \2\ As stated previously, our recommendation for tilefish now
relates only to tilefish from the Gulf of Mexico and not to Atlantic
tilefish.
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    FDA and EPA used sampling data from FDA and, to a limited extent,
from the U.S. National Marine Fisheries Service as the source for
mercury amounts in fish. FDA and EPA used data developed by the USDA to
estimate the amounts of the omega-3 fatty acids eicosapentaenoic acid
and docosahexanoic acid in fish.
    Additionally, the Agencies invite comment on the following:
    (1) Whether the final updated advice should track the Dietary
Guidelines for Americans 2010 more or less closely than the draft of
that updated advice now does.
    (2) Any new science that has become available since the Dietary
Guidelines for Americans 2010 were issued that would be relevant to the
updated advice.
    (3) Information upon which to base advice on young children's fish
consumption. There have been a number of studies that have examined the
effects of both postnatal exposure to mercury as well as postnatal fish
consumption by young children, but this research has not been as
extensive as the research on prenatal exposures and maternal fish
consumption.
    (4) As stated previously, suggestions for improving the clarity and
utility of the advice.
    (5) How to integrate advice from local advisories for those who
consume fish from local streams, rivers, and lakes.

IV. How To Submit Comments

    Interested persons may submit either electronic comments regarding
the draft documents to http://www.regulations.gov or written comments
regarding the draft documents to the Division of Dockets Management
(see ADDRESSES). It is only necessary to send one set of comments.
Identify comments with the docket number found in brackets in the
heading of this document. Received comments may be seen in the Division
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday,
and will be posted to the docket at http://www.regulations.gov.

V. How To Access the Draft Documents

    The draft documents described in this notice are available
electronically at http://www.fda.gov/Food/FoodborneIllnessContaminants/Metals/ucm393070.htm and at http://water.epa.gov/scitech/swguidance/fishshellfish/fishadvisories/index.cfm.

VI. References

    FDA has placed the following references on display in FDA's
Division of Dockets Management (see ADDRESSES). You may see them
between 9 a.m. and 4 p.m., Monday through Friday, and online at http://www.regulations.gov. (FDA has verified all the Web site addresses in
this reference section, but FDA is not responsible for any subsequent
changes to Web sites after this document publishes in the Federal
Register.)

1. Institute of Medicine, Committee on Nutrient Relationships in
Seafood: ``Selections to Balance Benefits and Risks,'' (2007).
Seafood Choices, Balancing Benefits and Risks. The National
Academies Press, Washington, DC.
2. ``What You Need to Know About Mercury in Fish and Shellfish; 2004
EPA and FDA Advice for: Women Who Might Become Pregnant, Women Who
are Pregnant, Nursing Mothers, Young Children,'' available at:
http://www.fda.gov/food/foodborneillnesscontaminants/buystoreservesafefood/ucm110591.htm.
3. U.S. Departments of Agriculture and Health and Human Services,
(2010). Dietary Guidelines for Americans 2010, chapter 4, ``Foods
and Nutrients to Increase,'' available at

http://health.gov/dietaryguidelines/2010.asp.
4. ``Report of the Dietary Guidelines Advisory Committee on the
Dietary Guidelines for Americans,'' 2010 to the Secretary of
Agriculture and the Secretary of Health and Human Services,
available at http://www.cnpp.usda.gov/DGAs2010-DGACReport.htm.
5. FAO/WHO, (2011). ``Report of the Joint FAO/WHO Expert
Consultation on the Risks and Benefits of Fish Consumption,'' Rome,
25-29 January 2010. FAO Fisheries and Aquaculture Report No. 978
FIPM/R978(En).
6. ``A Quantitative Assessment of the Net Effects on Fetal
Neurodevelopment From Eating Commercial Fish (As Measured by IQ and
also by Early Age Verbal Development in Children).'' Available at:
http://www.fda.gov/Food/FoodborneIllnessContaminants/Metals/ucm393211.htm.
7. Cohen, J.T., DC Bellinger, W.E. Connor, et al., (November 2005).
``A Quantitative Risk-Benefit Analysis of Changes in Population Fish
Consumption,'' American Journal of Preventive Medicine, vol. 29(4),
pp. 325-334.
8. Ginsberg, C.L. and B.F. Toal, (2009). Quantitative Approach for
Incorporating Methylmercury Risks and Omega-3 Fatty Acid Benefits in
Developing Species-Specific Fish Consumption Advice. Environmental
Health Perspectives, vol. 117(2), pp. 267-275.
9. Lando, A.M., S.B. Fein, and C.J. Choini[egrave]re, (2012).
``Awareness of Methylmercury in Fish and Fish Consumption Among
Pregnant and Postpartum and Women of Childbearing Age in the United
States,'' Environmental Research, vol. 116, pp. 85-92.
10. Daniels, J.L., M.P. Longnecker, A.S. Rowland, J. Golding, and
the ALSPAC Study Team University of Bristol Institute of Child
Health, (July 2004). ``Fish Intake During Pregnancy and Early
Cognitive Development of Offspring,'' Epidemiology, vol. 15(4), pp.
394-402.
11. FAO/WHO, (2011). ``Report of the Joint FAO/WHO Expert
Consultation on the Risks and Benefits of Fish Consumption,'' Rome,
January 25-29, 2010. FAO Fisheries and Aquaculture Report No. 978
FIPM/R978(En) (see page 26).
12. Institute of Medicine, Committee on Nutrient Relationships in
Seafood: ``Selections to Balance Benefits and Risks,'' (2006).
Seafood Choices, Balancing Benefits and Risks. The National
Academies Press, Washington, DC. (see page 240).
13. ``Mercury Levels in Commercial Fish and Shellfish 1990-2010,''
available at: http://www.fda.gov/Food/FoodborneIllnessContaminants/Metals/ucm115644.htm.

    Dated: June 6, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13584 Filed 6-10-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: July 16, 2008 (Volume 73, Number 137)]
[Rules and Regulations]
[Page 40760-40764]
[DOCID:fr16jy08-19]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[EPA-HQ-OPP-2007-1204; FRL-8371-6]

Bacillus thuringiensis Modified Cry1Ab Protein; Exemption from
the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of the Bacillus thuringiensis modified
Cry1Ab protein as identified under OECD Unique Identifier SYN-IR67B-1
when used as a plant-incorporated protectant in the food and feed
commodities of cotton; cotton, undelinted seed; cotton, refined oil;
cotton, meal; cotton, hay; cotton, hulls; cotton, forage; and cotton,
gin byproducts. Syngenta Seeds, Inc. submitted a petition to EPA under
the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the
Food Quality Protection Act of 1996 (FQPA), requesting an exemption
from the requirement of a tolerance. This regulation eliminates the
need to establish a maximum permissible level for residues of Bacillus
thuringiensis modified Cry1Ab protein as identified under OECD Unique
Identifier SYN-IR67B-1 when used as a plant-incorporated protectant in
cotton.

DATES: This regulation is effective July 16, 2008. Objections and
requests for hearings must be received on or before September 15, 2008,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-1204. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr.,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Alan Reynolds, Biopesticides and

Pollution Prevention Division (7511P), Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://
www.regulations.gov, you may access this ``Federal Register'' document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 174 through the
Government Printing Office's pilot e-CFR site at http://
www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. You must file your objection or request a hearing on
this regulation in accordance with the instructions provided in 40 CFR
part 178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2007-1204 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk on or before September 15, 2008.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2007-1204, by one of the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of January 30, 2008 (73 FR 5563) (FRL-8348-
4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 7F7290) by Syngenta Seeds, Inc., P.O. Box 12257, 3054 E.
Cornwallis Road, Research Triangle Park, NC 27709. The petition
requested that 40 CFR part 174 be amended by establishing an exemption
from the requirement of a tolerance for residues of Bacillus
thuringiensis modified Cry1Ab protein containing an additional 26 amino
acid sequence (``Geiser Motif'') in all crops and agricultural
commodities. A summary of the petition prepared by the petitioner,
Syngenta Seeds, Inc., was posted on www.regulations.gov in the docket
for this action (EPA-HQ-OPP-2007-1204). After review, the Agency
determined that the appropriate designation for the protein is Bacillus
thuringiensis modified Cry1Ab protein as identified under OECD Unique
Identifier SYN-IR67B-1 (hereafter referred to as modified Cry1Ab).
There was one comment received in response to the notice of filing. The
commenter objected to the petition, pesticide residues on food crops,
and the widespread use of Bacillus thuringiensis (Bt). The Agency
understands the commenter's concerns regarding tolerances of pesticide
residues on food. Pursuant to its authority under the FFDCA, EPA
conducted a comprehensive assessment of modified Cry1Ab protein,
including a review of acute oral toxicity data on modified Cry1Ab
protein, amino acid sequence comparisons to known toxins and allergens,
as well as data demonstrating that modified Cry1Ab protein is rapidly
degraded by gastric fluid in vitro, is not glycosylated, and is present
in low levels in plant tissues. Based on these data, the Agency has
concluded that there is a reasonable certainty that no harm will result
from dietary exposure to this protein as expressed in plant-
incorporated protectants. Thus, under the standard in FFDCA section
408(b)(2), a tolerance exemption is appropriate.
    In taking this action, EPA, pursuant to its authority under section
408(d)(4)(A)(i) of the FFDCA, is issuing a final regulation that varies
from the regulation sought by petitioner Syngenta Seeds, Inc.
Specifically, instead of issuing a tolerance exemption that covers
residues of the subject plant-incorporated protectant in all food
commodities, EPA is issuing a tolerance exemption that covers such
residues in those commodities in which it will be used as a plant-
incorporated protectant - in this case, the food and feed commodities
of cotton; cotton, undelinted seed; cotton, refined oil; cotton, meal;
cotton, hay; cotton, hulls; cotton, forage; and cotton, gin byproducts.
In this way, the tolerance exemption is coextensive with the registered
uses for this particular plant-incorporated protectant.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include

occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C) of FFDCA, which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue....
'' Additionally, section 408(b)(2)(D) of FFDCA requires that the Agency
consider ``available information concerning the cumulative effects of a
particular pesticide's residues '' and ``other substances that have a
common mechanism of toxicity.''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.

III. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness, and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children.

Mammalian Toxicity and Allergenicity Assessment

    Syngenta Seeds, Inc. has submitted acute oral toxicity data
demonstrating the lack of mammalian toxicity at high levels of exposure
to the pure modified Cry1Ab protein as identified under the
Organisation for Economic Co-operation and Development (OECD) Unique
Identifier SYN-IR67B-1 (hereafter referred to as modified Cry1Ab). The
modified Cry1Ab protein contains a 26 amino acid sequence that is found
at the C-terminus of the pro-toxin portion of the modified Cry1Ab
protein. This sequence naturally occurs in Cry1Ab protein expressed in
microbial Bacillus thuringiensis (Bt). The pro-toxin containing the
additional 26 amino acid sequence is enzymatically cleaved in the
insect gut to produce active Cry1Ab. These toxicity data demonstrate
the safety of the product at a level well above maximum possible
exposure levels that are reasonably anticipated in the crop. Basing
this conclusion on acute oral toxicity data without requiring further
toxicity testing and residue data is similar to the Agency position
regarding toxicity testing and the requirement of residue data for the
microbial Bacillus thuringiensis products from which this plant-
incorporated protectant was derived (See 40 CFR 158.2140). For
microbial products, further toxicity testing (Tiers II and III) and
residue data are triggered by significant adverse acute effects in
studies such as the acute oral toxicity study, to verify the observed
adverse effects and clarify the source of these effects.
    An acute oral toxicity study in mice indicated that modified Cry1Ab
is non-toxic to humans. Groups of five male and five female mice were
given 0 or 1,830 mg/kg bodyweight microbially-produced modified Cry1Ab
by oral gavage as a single dose. There were no effects on clinical
condition, body weight, food consumption, clinical pathology, organ
weight, or macroscopic or microscopic pathology that were attributed to
the test substance.
    When proteins are toxic, they are known to act via acute mechanisms
and at very low dose levels (Ref. 1). Therefore, since no acute effects
were shown to be caused by modified Cry1Ab, even at relatively high
dose levels, the modified Cry1Ab protein is not considered toxic.
    Since modified Cry1Ab is a protein, allergenic potential was also
considered. Currently, no definitive tests for determining the
allergenic potential of novel proteins exist. Therefore, EPA uses a
weight-of- evidence approach where the following factors are
considered: source of the trait; amino acid sequence comparison with
known allergens; and biochemical properties of the protein, including
in vitro digestibility in simulated gastric fluid (SGF) and
glycosylation. This approach is consistent with the approach outlined
in the Annex to the Codex Alimentarius ``Guideline for the Conduct of
Food Safety Assessment of Foods Derived from Recombinant-DNA Plants.''
The allergenicity assessment for modified Cry1Ab follows:
    1. Source of the trait. Bacillus thuringiensis is not considered to
be a source of allergenic proteins.
    2. Amino acid sequence. A comparison of the amino acid sequence of
modified Cry1Ab with known allergens showed no significant sequence
identity over 80 amino acids or identity at the level of 8 contiguous
amino acid residues.
    3. Digestibility. Modified Cry1Ab was rapidly digested in simulated
gastric fluid containing pepsin.
    4. Glycosylation. Modified Cry1Ab expressed in cotton was shown not
to be glycosylated.
    5. Conclusion. Considering all of the available information, EPA
has concluded that the potential for modified Cry1Ab to be a food
allergen is minimal.
    Although modified Cry1Ab was only shown not to be glycosylated in
cotton, it is unlikely to be glycosylated in any other crops because in
order for a protein to be glycoslyated, it needs to contain specific
recognition sites for the enzymes involved in glycosylation, and the
mechanisms of protein glycosylation are similar in different plants
(Ref. 2).

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of FFDCA directs EPA
to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or buildings
(residential and other indoor uses).
    The Agency has considered available information on the aggregate
exposure levels of consumers (and major identifiable subgroups of
consumers) to the pesticide chemical residue (i.e., the modified Cry1Ab
protein) and to other related substances. These considerations include
dietary exposure under the tolerance exemption and all other exposures
from non-occupational sources. Exposure via the skin or inhalation is
not likely since the plant-incorporated protectant is contained within
plant cells, which essentially eliminates these exposure routes or
reduces these exposure routes to negligible. In addition, even if
exposure can occur through inhalation, the potential for modified
Cry1Ab to be an allergen is low, as discussed above. Although the
allergenicity assessment focuses on potential to be a food allergen,
the data also indicate a low potential for modified Cry1Ab to be an
inhalation allergen. Exposure via residential or lawn use to infants
and children is also not expected because the use sites for the
modified Cry1Ab protein is agricultural. Dietary exposure may occur
from ingestion of processed cotton products but is expected to be very
low because the already low expression levels in the seed would be
reduced further by the heat and pressure used for processing. Also,
dietary exposure may theoretically occur

through exposure in drinking water because plant stubble may release
modified Cry1Ab protein into ground water upon decay. This protein
would not be expected to survive in the soil due to microbial
degradation, adherence to soil components and removal upon exposure to
drinking water treatment procedures. In addition, oral toxicity testing
showed no adverse effects.

V. Cumulative Effects

    Pursuant to FFDCA section 408(b)(2)(D)(v), EPA has considered
available information on the cumulative effects of such residues and
other substances that have a common mechanism of toxicity. These
considerations included the cumulative effects on infants and children
of such residues and other substances with a common mechanism of
toxicity. Because there is no indication of mammalian toxicity from the
plant-incorporated protectant, there is no common mechanism of toxicity
for this protein; therefore, section 408(b)(2)(D)(v) does not apply.

VI. Determination of Safety for U.S. Population, Infants and Children

A. Toxicity and Allergenicity Conclusions

    The data submitted and cited regarding potential health effects for
the modified Cry1Ab protein includes the characterization of the
expressed modified Cry1Ab protein in cotton, as well as the acute oral
toxicity study, amino acid sequence comparisons to known allergens, and
in vitro digestibility of the protein. The results of these studies
were used to evaluate human risk, and the validity, completeness, and
reliability of the available data from the studies were also
considered.
    Adequate information was submitted to show that the modified Cry1Ab
test material derived from microbial culture was biochemically and
functionally equivalent to the protein in the plant. Microbially
produced protein was used in the safety studies so that sufficient
material for testing was available.
    The acute oral toxicity data submitted support the prediction that
the modified Cry1Ab protein is non-toxic to humans. As mentioned above,
when proteins are toxic, they are known to act via acute mechanisms and
at very low dose levels (Ref. 1). Since no treatment-related adverse
effects were shown to be caused by the Cry1Ab protein, even at
relatively high dose levels, the modified Cry1Ab protein is not
considered toxic. Basing this conclusion on acute oral toxicity data
without requiring further toxicity testing and residue data is similar
to the Agency position regarding toxicity and the requirement of
residue data for the microbial Bacillus thuringiensis products from
which this plant-incorporated protectant was derived (See 40 CFR
158.2140). For microbial products, further toxicity testing and residue
data are triggered when significant adverse effects are seen in studies
such as the acute oral toxicity study. Further studies verify the
observed adverse effects and clarify the source of these effects.
    Residue chemistry data were not required for a human health effects
assessment of the subject plant-incorporated protectant ingredients
because of the lack of mammalian toxicity. However, data submitted
demonstrated low levels of the modified Cry1Ab protein in cotton
tissues.
    Since Cry1Ab is a protein, potential allergenicity is also
considered as part of the toxicity assessment. Considering all of the
available information (1) modified Cry1Ab originates from a non-
allergenic source; (2) modified Cry1Ab has no sequence similarities
with known allergens; (3) modified Cry1Ab is not glycosylated; and (4)
modified Cry1Ab is rapidly digested in simulated gastric fluid; EPA has
concluded that the potential for modified Cry1Ab to be an allergen is
minimal.
    Neither available information concerning the dietary consumption
patterns of consumers (and major identifiable subgroups of consumers
including infants and children) nor safety factors that are generally
recognized as appropriate for the use of animal experimentation data
were evaluated. The lack of mammalian toxicity at high levels of
exposure to the modified Cry1Ab protein, as well as the minimal
potential to be an allergen, demonstrate the safety of the product at
levels well above possible maximum exposure levels anticipated.
    The genetic material necessary for the production of the plant-
incorporated protectant active ingredient include the nucleic acids
(DNA, RNA) that encode these proteins and regulatory regions. The
genetic material (DNA, RNA) necessary for the production of the
modified Cry1Ab protein has been exempted from the requirement of a
tolerance under 40 CFR 174.507--nucleic acids that are part of a plant-
incorporated protectant.

B. Infants and Children Risk Conclusions

    FFDCA section 408(b)(2)(C) provides that EPA shall assess the
available information about consumption patterns among infants and
children, special susceptibility of infants and children to pesticide
chemical residues and the cumulative effects on infants and children of
the residues and other substances with a common mechanism of toxicity.
In addition, FFDCA section 408(b)(2)(C) also provides that EPA shall
apply an additional tenfold margin of safety for infants and children
in the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database unless EPA determines
that a different margin of safety will be safe for infants and
children.
    In this instance, based on all the available information, the
Agency concludes that there is a finding of no toxicity for the
modified Cry1Ab protein. Thus, there are no threshold effects of
concern and, as a result, the provision requiring an additional margin
of safety does not apply. Further, the considerations of consumption
patterns, special susceptibility, and cumulative effects do not apply.

C. Overall Safety Conclusion

    There is a reasonable certainty that no harm will result from
aggregate exposure to the U.S. population, including infants and
children, to the modified Cry1Ab protein and the genetic material
necessary for its production. This includes all anticipated dietary
exposures and all other exposures for which there is reliable
information. The Agency has arrived at this conclusion because, as
discussed above, no toxicity to mammals has been observed, nor any
indication of allergenicity potential for the plant-incorporated
protectant.

VII. Other Considerations

A. Endocrine Disruptors

    The pesticidal active ingredient is a protein, derived from a
source that is not known to exert an influence on the endocrine system.
Therefore, the Agency is not requiring information on the endocrine
effects of this plant-incorporated protectant at this time.

B. Analytical Method(s)

    A lateral flow enzyme-linked immunosorbent assay (ELISA) protocol
has been provided to the Agency for detecting modified Cry1Ab in
cotton.

C. Codex Maximum Residue Level

    No Codex maximum residue level exists for the plant-incorporated
protectant Bacillus thuringiensis modified Cry1Ab protein.

VIII. References

    1. Sjoblad, Roy D., et al., ``Toxicological Considerations for

Protein Components of Biological Pesticide Products,'' Regulatory
Toxicology and Pharmacology 15, 3-9 (1992).
    2. Lerouge, P., Cabanes-Macheteau, M., Rayon, C., Fichette-
Lain[egrave], A-C., Gomord, V., and Faye, L., ``N-Glycoprotein
biosynthesis in plants: recent developments and future trends,'' Plant
Molecular Biology 38: 31-48 (1998).

IX. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, Actions Concerning Regulations
That Significantly Affect Energy Supply, Distribution, or Use (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., nor does it require any special
considerations under Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

X. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this 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 this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 174

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: June 26, 2008.
Debra Edwards,
Director, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 174--[AMENDED]

0
1. The authority citation for part 174 continues to read as follows:

    Authority: 7 U.S.C. 136-136y; 21 U.S.C. 346a and 371.

0
2. Section 174.529 is added to subpart W to read as follows:

Sec.  174.529  Bacillus thuringiensis modified Cry1Ab protein as
identified under OECD Unique Identifier SYN-IR67B-1 in cotton;
exemption from the requirement of a tolerance.

    Residues of Bacillus thuringiensis modified Cry1Ab protein as
identified under OECD Unique Identifier SYN-IR67B-1 are exempt from the
requirement of a tolerance when used as a plant-incorporated protectant
in cotton; cotton, undelinted seed; cotton, refined oil; cotton, meal;
cotton, hay; cotton, hulls; cotton, forage; and cotton, gin byproducts.
[FR Doc. E8-16277 Filed 7-15-08; 8:45 am]

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[Federal Register Volume 83, Number 40 (Wednesday, February 28, 2018)]
[Notices]
[Pages 8665-8666]
[FR Doc No: 2018-04093]

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ENVIRONMENTAL PROTECTION AGENCY

[Petitions IV-2016-11 and IV-2017-17; FRL-9974-65--Region 4]

Clean Air Act Operating Permit Program; Petitions for Objection
to State Operating Permits for Tennessee Valley Authority--Gallatin
Fossil Plant (Sumner County, Tennessee)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of final order on petitions to object to state operating
permits.

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SUMMARY: The Environmental Protection Agency (EPA) Administrator signed
an Order, dated January 30, 2018, denying the petitions submitted by
Sierra Club (Petitioner) objecting to a proposed Clean Air Act (CAA)
title V operating permit issued to Tennessee Valley Authority (TVA) for
its Gallatin Fossil Fuel Plant located in Gallatin, Sumner County,
Tennessee. The Order responds to two petitions: The first, dated August
8, 2016, requested that the EPA object to the proposed renewal permit
no. 561209; the second, dated November 20, 2017, requested that the EPA
object to the proposed significant modification to permit no. 561209.
Both permitting actions were issued by the Tennessee Department of
Environment and Conservation (TDEC). The Order constitutes a final
action on the petitions addressed therein.

ADDRESSES: Copies of the Order, the petitions, and all pertinent
information relating thereto are on file at the following location: EPA
Region 4; Air, Pesticides and Toxics Management Division; 61 Forsyth
Street SW; Atlanta, Georgia 30303-8960. The Order is also available
electronically at the following address: https://wcms.epa.gov/sites/production/files/2018-02/documents/tvagallatinorder2018.pdf.

FOR FURTHER INFORMATION CONTACT:  Art Hofmeister, Air Permits Section,
EPA Region 4, at<PHONE_NUMBER> or [email protected].

SUPPLEMENTARY INFORMATION: The CAA affords the EPA a 45-day period to
review and, as appropriate, the authority to object to operating
permits proposed by state permitting authorities under title V of the
CAA, 42 U.S.C. 7661-7661f. Section 505(b)(2) of the CAA and 40 CFR
70.8(d) authorize any person to petition the EPA Administrator to
object to a title V operating permit within 60 days after the
expiration of the EPA's 45-day review period if EPA has not objected on
its own initiative. Petitions must be based only on objections to the
permit that were raised with reasonable specificity during the public
comment period provided by the state, unless the petitioner
demonstrates that it was impracticable to raise these issues during the
comment period or the grounds for the issues arose after this period.
Pursuant to sections 307(b) and 505(b)(2) of the CAA, a petition for
judicial review of those parts of the Order that deny issues in the
petition may be filed in the United States Court of Appeals for the
appropriate circuit within 60 days from the date this notice is
published in the Federal Register.
    Petitioner submitted petitions requesting that the EPA object to
the proposed CAA title V operating permit no. 561209 and the subsequent
significant modification to this permit., both issued by TDEC to TVA.
Petitioner claims that these permitting actions: Fail to include
monitoring requirements adequate to ensure compliance with opacity,
particulate matter, and fugitive dust requirements; fail to include
reporting requirements to ensure compliance with a previous consent
decree; include startup/shutdown provisions that are inconsistent with
the CAA; impose an unreasonably permissive limit for sulfur dioxide
(SO2); and include a limit that fails to protect the one-
hour National Ambient Air Quality Standard for SO2.
    On January 30, 2018, the Administrator issued an Order denying

the petitions. The Order explains EPA's basis for denying the
petitions.

    Dated: February 8, 2018.
Onis ``Trey'' Glenn, III,
Regional Administrator, Region 4.
[FR Doc. 2018-04093 Filed 2-27-18; 8:45 am]
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