June 27, 2016

FDA/HHS Technical Assistance on
Senate Agriculture Committee draft legislation
to establish a national disclosure standard for bioengineered foods(EDW16734)
These comments are intended only to provide technical assistance on the draft bill and are
by no means to be interpreted as any kind of approval or endorsement of the proposed
legislation by HHS and its agencies or the Administration.

General Comments
The bill would give USDA alone certain regulatory authorities over claims on humanfood labeling that the food is bioengineered. Those authorities would apply to any food that issubject to labeling requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act)and to certain foods that are subject to labeling requirements of the Federal Meat Inspection Act
or the Egg Products Inspection Act. Thus, the bill would give USDA these authorities over foodlabeling that is otherwise under FDA's sole regulatory jurisdiction (as well as over certain otherfoods).
FDA has a long-held policy position that the use of genetic engineering (GE) in the
production of food has not presented any safety concerns for such foods as a class, and therefore
the use of GE techniques in the production of food is not a material fact that must be disclosed
on the labeling of food products. Since FDA's key responsibilities and focus with respect to foodare for safety, any issuance by FDA of regulations governing labeling of foods as bioengineered
could be understood by the public as reflecting on the safety of such foods. In the absence ofreliable data indicating any safety concerns with bioengineered foods as a class, FDA has not
expressed a desire to be the responsible agency for any such regulatory program.
We note that provisions to allow information regarding the GE content of food to bepresented only in an electronically accessible form and not on the package label would be intension with FDA’s statute and regulations, which require disclosures on food labels. For
example, under FDA's provisions, information such as Nutrition Facts and the list of ingredients
must be displayed directly on the label. To avoid potential conflicts, the drafters could makeclear in this bill that it will not affect FDA’s labeling requirements in the future.
We are concerned that USDA’s regulations implementing the mandatory standard under
this bill could conflict with FDA’s labeling requirements. For example, depending on what
USDA requires for small packages, it is possible that a manufacturer would not be able to fit
both FDA’s required statements and USDA’s required information on the label. Here also, toavoid conflicts, the drafters could amend the bill to state clearly that it shall not be construed toauthorize a regulatory requirement that would supersede or conflict with any labelingrequirement under the FD&C Act.

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Technical Comments
We note several points in the drafting of the bill that raise confusion (references of theform "(5:4-7)" mean page 5, lines 4-7, of the bill.):
1. (2:10-15) The definition of "bioengineering" (new sec. 291) would result in asomewhat narrow scope of coverage. First, in subparagraph (A), the phrase “that containsgenetic material” will likely mean that many foods from GE sources will not be subject to thisbill. For instance, oil made from GE soy would not have any genetic material in it. Likewise,
starches and purified proteins would not be covered.
Second, subparagraph (B) would limit coverage to foods where the genetic modification"could not otherwise be obtained through conventional breeding or found in nature.” It may bedifficult to demonstrate that a particular modification could not be obtained through conventional
breeding (or even that it could not occur in nature). In addition, it is unclear whether this refers
to the effect of the rDNA construct or the location in the genome (i.e., the former could arguably
be obtained via conventional breeding, whereas the latter cannot).
2. (3:5 - 4:2) This scope provision is problematic. All foods (as defined in the FD&CAct) are "subject to ... the labeling requirements under the [FD&C Act]," so paragraph (1) of thecurrent draft would seem to make all foods subject to the bill, and thus paragraph (2) would besuperfluous. It appears that the intent is to have the bill apply to all foods except those that areessentially meat, poultry, or eggs, and that the drafters may have assumed, incorrectly, that
products covered by the Federal Meat Inspection Act, the Poultry Products Inspection Act, or theEgg Products Inspection Act are not covered by the FD&C Act. If this is indeed the intent, wesuggest that the following revision of new subsection (c):"(c) APPLICATION TO FOODS.—This subtitle shall apply to a food, except for a food thatsatisfies both of the following conditions:"(1) COVERAGE BY OTHER STATUTES.—The food is subject to the labeling requirements
under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection
Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 103 et seq.).
"(2) PREDOMINANT INGREDIENT.—The most predominant ingredient of the food —"(A) would independently be subject to the labeling requirements under one of the Acts
identified in paragraph (1); or"(B) is broth, stock, water, or a similar solution, and the second-most predominantingredient of the food would independently be subject to the labeling requirements under
one of the Acts identified in paragraph (1)."
If this is not the intent, we recommend clarification.
3. (4:8-11) New sec. 293(a)(1) says that USDA is to establish a disclosure standard withrespect to any food that is bioengineered and “any food that may be bioengineered”. It is notclear whether this means any food that is susceptible to bioengineering or any food about which
it is uncertain whether it is in fact bioengineered.

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4. (4:23 -- 5:2) New sec. 293(b)(2)(A) would require the USDA regulations to "prohibit afood derived from an animal to be considered a bioengineered food solely because [of a certainfact]". This is unclear -- the language of "prohibit[ion]" and of 'be[ing] considered", if taken
literally, would mean that an advocacy group that thought of these foods as being bioengineered
would thereby have violated the USDA regulation and could be subject to sanctions.
Presumably what was meant was that the regulation "shall provide that a food derived from ananimal shall not be deemed, for purposes of this subtitle or for the purposes of the regulation,
solely because ...."
5. (6:19 - 7:2) New sec. 293(b)(3) refers to a food that "has successfully completed thepre-market Federal regulatory review process". Because there are a number of different premarket review paths as well as the voluntary consultation process, we suggest adding“applicable” before “pre-market Federal regulatory review process.”

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